Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminated by the Centers for Disease Control and Prevention 

and should not be construed to represent any agency determination or policy. 1

Appendix 1. Core Section

Draft Guideline for the Prevention of Surgical Site Infections
Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminated by the Centers for Disease Control and Prevention 

and should not be construed to represent any agency determination or policy. 2

Table of Contents

SECTION 1. SEARCH STRATEGIES ........................................................................................................................................................................................ 4

SECTION 2: GRADE, EVIDENCE AND RISK OF BIAS ASSESSMENT TABLES........................................................................................................................... 6

Q1 PARENTERAL ANTIMICROBIAL PROPHYLAXIS (AMP)................................................................................................................................................ 6

GRADE TABLE Q1 ......................................................................................................................................................................................................... 6

EVIDENCE TABLE Q1 .................................................................................................................................................................................................. 27

RISK OF BIAS ASSESSMENTS OF STUDIES Q1............................................................................................................................................................. 93

Q2 NON-PARENTERAL ANTIMICROBIAL PROPHYLAXIS ................................................................................................................................................ 96

GRADE TABLE Q2 ....................................................................................................................................................................................................... 96

EVIDENCE TABLE Q2 ................................................................................................................................................................................................ 100

RISK OF BIAS ASSESSMENTS OF STUDIES Q2........................................................................................................................................................... 125

Q3 GLYCEMIC CONTROL ............................................................................................................................................................................................. 126

GRADE TABLE Q3 ..................................................................................................................................................................................................... 126

EVIDENCE TABLE Q3 ................................................................................................................................................................................................ 129

RISK OF BIAS ASSESSMENTS OF STUDIES Q3........................................................................................................................................................... 132

Q4-5 NORMOTHERMIA............................................................................................................................................................................................... 133

GRADE TABLE Q4-5.................................................................................................................................................................................................. 133

EVIDENCE TABLE Q4-5............................................................................................................................................................................................. 136

RISK OF BIAS ASSESSMENTS OF STUDIES 4-5 .......................................................................................................................................................... 145

Q6-7OXYGENATION .................................................................................................................................................................................................... 146

GRADE TABLE Q6-7.................................................................................................................................................................................................. 146

EVIDENCE TABLE Q6-7............................................................................................................................................................................................. 152

RISK OF BIAS ASSESSMENTS OF STUDIES Q6-7 ....................................................................................................................................................... 177

Q8-10 ANTISEPTIC PROPHYLAXIS................................................................................................................................................................................ 178
Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminated by the Centers for Disease Control and Prevention 

and should not be construed to represent any agency determination or policy. 3

GRADE TABLE Q8-10................................................................................................................................................................................................ 178

EVIDENCE TABLE Q8-10........................................................................................................................................................................................... 188

RISK OF BIAS ASSESSMENTS OF STUDIES Q8-10 ..................................................................................................................................................... 243

SECTION 3: EVALUATION OF THE RISK OF BIAS OF AN INDIVIDUAL STUDY................................................................................................................... 245

CHECKLIST FOR SYSTEMATIC REVIEWS....................................................................................................................................................................... 245

CHECKLIST FOR RANDOMIZED CONTROLLED TRIALS ................................................................................................................................................. 245

CHECKLIST FOR OTHER CONTROLLED STUDIES .......................................................................................................................................................... 246

SECTION 4: EVIDENCE TABLE EXTRACTION TEMPLATES ................................................................................................................................................ 247

1. SYSTEMATIC REVIEW (SR) EXTRACTION TEMPLATE ............................................................................................................................................... 247

2. RANDOMIZED CONTROLLED TRIAL (RCT) EXTRACTION TEMPLATE ....................................................................................................................... 247

3. OTHER CONTROLLED STUDIES EXTRACTION TEMPLATE ........................................................................................................................................ 248

SECTION 5: STUDY TYPE DETERMINATION ALGORITHM................................................................................................................................................ 249

SECTION 6: REFERENCES................................................................................................................................................................................................. 250
Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminated by the Centers for Disease Control and Prevention 

and should not be construed to represent any agency determination or policy. 4

SECTION 1. SEARCH STRATEGIES

MEDLINE

# Search History Results

1 exp Surgical Wound Infection/ 25,893

2 "surgical site infection*".af. 2,130

3 1 or 2 26,382

4 limit 3 to English language 19,318

5 limit 4 to yr="1998 -Current" 8,709

6 limit 5 to guideline 19

7 limit 5 to systematic reviews 429

8 limit 5 to practice guideline 27

9 limit 5 to meta analysis 161

10 limit 5 to "reviews (maximizes specificity)" 262

11 6 or 7 or 8 or 9 or 10 469

12 limit 5 to randomized controlled trial 715

13 11 or 12 1,170

EMBASE

# Search History Results

1 'surgical infection'/exp or 'surgical site infection' or 'surgical wound infection' 19,658

2 limit 1 to English language 13,666

3 limit 2 to 'randomized controlled trial'/de 749

4 limit 3 [1998-2012]/py 566

5 limit 2 to [review] 1,580

6 limit 2 to ('meta analysis'/de OR 'practice guideline'/de) 639

7 'systematic review'/exp 43,081
Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminated by the Centers for Disease Control and Prevention 

and should not be construed to represent any agency determination or policy. 5

8 5 and 7 82

9 6 or 8 679

10 limit 9 to [1998-2012]/py 654

11 4 or 10 1,220
Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminated by the Centers for Disease Control and Prevention 

and should not be construed to represent any agency determination or policy. 6

SECTION 2: GRADE, EVIDENCE AND RISK OF BIAS ASSESSMENT TABLES

Q1 PARENTERAL ANTIMICROBIAL PROPHYLAXIS (AMP)

GRADE TABLE Q1

Comparison Outcome

Quantity 

and Type of 

Evidence

Findings Starting 

GRADE

Decrease GRADE Increase 

GRADE

GRADE of 

Evidence for 

Outcome

Overall 

GRADE of 

Evidence 

Base

Study QualityConsistencyDirectnessPrecisionPublication BiasLarge MagnitudeDose-responseConfounders

Q1. What are the most effective strategies for administering parenteral AMP to reduce the risk of SSI?

Q1B. What is the optimal timing of AMP in cesarean section: prior to skin incision or at cord clamping?

Cesarean 

section 

AMP Timing: 

Prior to skin 

incision vs. 

at cord 

clamping

SSIEndometri

tis*

1 SR 1

 N=749 Mothers from 3 RCTs 2, 3, 4all undergoing 

Cesarean section, overall RR: 0.47 (95%CI 0.26-

0.85); P=0.012 indicating a 53% overall reduction 

in risk with administration of AMP prior to skin 

incision

High 0 0 0 0 0 0 0 0 High

High

SSI 

Incisional 1 SR 1

 N=149 mothers from 3 RCTs 2,3,4all undergoing 

cesarean section, overall RR: 0.60 (95%CI 0.30-

1.21); P=0.151 1indicating trend toward reduction 

in risk with administration of AMP prior to skin 

incision, though it is not statistically significant

High 0 0 0 0 0 0 0 0 High

Neonatal 

Sepsis 1 SR 1

 N=771 Neonates from 3 RCTs 2,3,4all delivered by 

Cesarean section, administration of AMP to the 

mother prior to skin incision did not significantly 

affect proven neonatal sepsis- Overall RR: 0.93

(95%CI 0.45-1.96); P=0.86 1

 In 1 RCT 2, 13 cases of sepsis among 357 neonates 

did not show different causative organisms 

between groups or increased antimicrobial 

resistance

High 0 0 0 0 0 0 0 0 High
Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminated by the Centers for Disease Control and Prevention 

and should not be construed to represent any agency determination or policy. 7

Comparison Outcome

Quantity 

and Type of 

Evidence

Findings Starting 

GRADE

Decrease GRADE Increase 

GRADE

GRADE of 

Evidence for 

Outcome

Overall 

GRADE of 

Evidence 

Base

Study QualityConsistencyDirectnessPrecisionPublication BiasLarge MagnitudeDose-responseConfounders

Neonatal 

Sepsis 

Workup

1 SR 1

 N=771 Neonates delivered by cesarean section 

from 3 RCTs, administration of AMP to the mother 

prior to skin incision did not significantly affect 

suspected sepsis that required workup: Overall 

RR: 1 (95%CI 0.71-1.42); P=0.99

High 0 0 0 0 0 0 0 0 High

NICU 

Admission 1 SR 1

 N=681 Neonates from 2 RCTs 2,3all delivered by 

Cesarean section, , administration to the mother 

prior to skin incision did not significantly affect 

NICU admission- Overall RR: 1.07 (95%CI 0.51-

2.24); P=0.86 1

 In 1 RCT 2 with 357 neonates, administration 

prior to skin incision resulted in significantly 

shorter NICU stay (p<0.01)

High 0 0 0 0 0 0 0 0 High

Q1D. How safe and effective is intraoperative redosing of AMP?

1 

Preoperativ

e dose

vs. 

1 

preoperativ

e dose plus s 

additional 

dose at 2h 

intraoperati

vely

SSI* 

(Abdomin

al)

1 RCT 5

 In 1 RCT (N=278) in elective colorectal surgery, 

271 patients completed 30 day follow up. No 

difference: 10/143 (7%) vs. 7/128 (5%); p>0.05

 Patients with procedure duration >3h had a 

significantly higher the probability of infection 

(5/37(14%) as compared to those with 2-3hr 

(5/127(4%) or <2h duration 7/107(7%); p<0.05. Of 

note, 36/164 (22%) of patients with procedure 

durations ≥2h were not redosed intraoperatively 

(antimicrobial half-life was 68 min. Study does not 

report these infections by single dose versus 

redosed.

 Increasing fecal contamination almost doubled 

the infection rate at every level from 2/67(3%) in 

those with no contamination, to 10/162(6%) in 

those with moderate and 5/38(13%) in those with 

High 0 0 0 -1 0 0 0 0 Moderate Moderate
Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminated by the Centers for Disease Control and Prevention 

and should not be construed to represent any agency determination or policy. 8

Comparison Outcome

Quantity 

and Type of 

Evidence

Findings Starting 

GRADE

Decrease GRADE Increase 

GRADE

GRADE of 

Evidence for 

Outcome

Overall 

GRADE of 

Evidence 

Base

Study QualityConsistencyDirectnessPrecisionPublication BiasLarge MagnitudeDose-responseConfounders

gross contamination; p<0.05 (contamination 

unknown in 4). Study does not report these 

infections by single dose versus redosed. 

IntraAbdomina

l Abscess

1 RCT 5

 No difference: 8/146 (5%) vs. 10/132(8%) High 0 0 0 -1 0 0 0 0 Moderate

Perineal 

Wound 

Infection

1 RCT 5

 No difference: 4/9 vs. 4/9 High 0 0 0 -1 0 0 0 0 Moderate

Antimicro

bial 

resistance

1 RCT 5  No difference: 1 minor SSI in each group culture 

positive for MRSA as the sole organism High 0 0 0 -1 0 0 0 0 Moderate

Q1E. How safe and effective is postoperative AMP and what is the optimal duration?

All Surgeries

None

vs. 

<24h

SSI

19 RCT 6, 7, 

8, 9, 10, 11, 12, 

13, 14, 15, 16, 17, 

18, 19, 20, 21, 22, 

23, 24

 In a meta-analysis of 19 RCTs, (N=13,408) no 

benefit of continuing AMP after the wound 

is closed in the operating room: OR: 1.24; 

(95% CI: 0.96 – 1.61); p=0.10.

High 0 0 0 0 0 0 0 0 High High

Cardiac Surgery

None

vs.

≤24h SSI* 1 RCT 7

 ≤24h AMP duration reduced the risk of SSI at 12 

month follow up in 1 large RCT with N=838 

patients undergoing CABG with or without valve 

replacement: 30 /419 (7.2%) vs. 15/419 (3.6%); 

p=0.02. Overall rate of SSI was 5.9%. 

 Patients received their first dose of AMP 20-30 

High 0 0 0 -1 0 0 0 0 Moderate Moderate
Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminated by the Centers for Disease Control and Prevention 

and should not be construed to represent any agency determination or policy. 9

Comparison Outcome

Quantity 

and Type of 

Evidence

Findings Starting 

GRADE

Decrease GRADE Increase 

GRADE

GRADE of 

Evidence for 

Outcome

Overall 

GRADE of 

Evidence 

Base

Study QualityConsistencyDirectnessPrecisionPublication BiasLarge MagnitudeDose-responseConfounders

min after induction of anesthesia and those whose 

procedures lasted >3h were redosed 

intraoperatively.

 The “no postoperative AMP” group also had 

statistically higher proportion of patients on 

intraaortic balloon pump postoperatively (0.03) 

and received more blood transfusions 

(0.01).Patients who presented with both 

osteomyelitis and mediastinitis were reported as 

both an organ/space and a deep incisional SSI. 

Between 1 and 3 of 5 deep SSI patients in the “no 

postoperative AMP group” may have has both. 

Since the study did not stratify those results, deep 

SSI data were excluded from this analysis.

 No S. aureus decolonization was performed

Organ/ 

Space 

Sternal 

SSI*

1 RCT 7

 No difference: 14/419 (3.3%) vs. 8/419 (1.9%); 

P=0.19 at 12 month follow up.

 No statistically significant differences between 

groups for osteomyelitis, mediastinitis, or 

endocarditis individually.

High 0 0 0 -1 0 0 0 0 Moderate

Superficial 

SSI*` 1 RCT 7

 ≤24 AMP reduced the risk of superficial incisional 

SSI: 16 (3.8%) vs. 7 (1.7%); p=0.04 

 However, it is not clear if incisional SSIs included 

both sternal and donor site wounds.

High 0 0 0 -1 0 0 0 0 Moderate

Mortality 1 RCT 7  No difference at 30d, 90d and 365d (P=0.12, 0.18, 

and 0.34, respectively) High 0 0 0 -1 0 0 0 0 Moderate

Length of 

stay

1 RCT 7

 No differences: (14.75±15.8 vs. 12.2±14.2; 

P=0.25. 

 Of note, patients in both groups were hospitalized 

for approximately 10 days before surgery and had 

High 0 0 0 -1 0 0 0 0 Moderate
Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminated by the Centers for Disease Control and Prevention 

and should not be construed to represent any agency determination or policy. 10

Comparison Outcome

Quantity 

and Type of 

Evidence

Findings Starting 

GRADE

Decrease GRADE Increase 

GRADE

GRADE of 

Evidence for 

Outcome

Overall 

GRADE of 

Evidence 

Base

Study QualityConsistencyDirectnessPrecisionPublication BiasLarge MagnitudeDose-responseConfounders

long mean ICU stays: 10.3±10.9 vs. 9.1±8.7; 

p=0.09. 

Antimicro

bial 

resistance

1 RCT 7

 The most frequently isolated organisms were 

Staphylococcus epidermis and Staphylococcus 

aureus (p≥0.05) and the majority of SSIs were 

polymicrobial: 57.1% vs. 60.0%. 

 MRSA: 4/35(11.4%) vs. 9/15 (60%); p=0.001

High 0 0 0 -1 0 0 0 0 Moderate

None 

vs.

72-96h

Organ/Sp

ace SSI* 

Sternal 

2 RCT 25, 26 No difference in meta-analysis (N=908) of 2 RCTs, OR: 

4.28; 95% CI: 0.47 – 39.24; p=0.20. High 0 0 0 -1 0 0 0 0 Moderate

Moderate

Superficial 

Sternal 

SSI*`

3 RCT 25, 

27,26

 No difference in meta-analysis (N=993) of 3 RCTs: 

OR: 1.23; 95% CI: 0.44 – 3.45; p=0.69. High 0 0 0 -1 0 0 0 0 Moderate

SSI* Leg 

Graft 

Donor site

1 RCT 25

 No difference in 1 large RCT where 766 (91%) of 

844 CABG patients underwent leg vein harvest. 

(23/377) (6.1%) vs. 20/389 (5.1%); 7 day follow up. 

Overall donor site SSI rate 5.6% (43/766) 

High 0 0 0 -1 0 0 0 0 Moderate

Deep Leg 

Graft 

Donor Site 

SSI*

1 RCT 25

 No difference: 18 reports of wound dehiscence in 

each group (7 day follow up). The authors 

included donor site wound dehiscence in their 

calculation of the overall infection rate. 

High 0 0 0 -1 0 0 0 0 Moderate
Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminated by the Centers for Disease Control and Prevention 

and should not be construed to represent any agency determination or policy. 11

Comparison Outcome

Quantity 

and Type of 

Evidence

Findings Starting 

GRADE

Decrease GRADE Increase 

GRADE

GRADE of 

Evidence for 

Outcome

Overall 

GRADE of 

Evidence 

Base

Study QualityConsistencyDirectnessPrecisionPublication BiasLarge MagnitudeDose-responseConfounders

Superficial 

Leg Graft 

Donor Site 

SSI*

1 RCT 25  No difference: 5/377 (1.3%) vs. 2/389 (0.5%); 

p=0.26 (7 day follow up) High 0 0 0 -1 0 0 0 0 Moderate

Length of 

Stay 1 RCT 27

 Significantly shorter length of stay with 

postoperative AMP in one small (N=85) RCT with 

data collected 35 years ago: 12.03±4.2 versus 

14.6±7.5 days; P<0.05

High -1 0 0 -1 0 0 0 0 Low

Antimicro

bial 

Resistance

2 RCT 27,26

 One study 27 both incisional SSIs were 

Staphylococcus aureus

 One study 26 incisional SSI: The “no postoperative 

AMP group” had 1 Staphylococcus aureus and 1 

Staphylococcus epidermis infection as compared 

to 1 Serratia marcescens and 1 Enterococcus 

infection in those with postoperative AMP. The 

one case of endocarditis in the group with “no 

postoperative AMP” was a Staphylococcus 

epidermis

High 0 0 0 -1 0 0 0 0 Moderate

Thoracic Surgery

None 

vs.

2 days

SSI* 1 RCT 28

 No difference in 1 RCT (N=203) of patients 

undergoing thoracic surgery (thoracotomy with 

lung resection): 7/102 (7%) vs. 2/101 (2%) P=0.11 

 Overall SSI rate was 4.4%. 

High 0 0 0 -1 0 0 0 0 Moderate

Moderate Organ/ 

Space SSI* 

(empyem

a)

1 RCT 28

 Significantly more empyema in group without 

postoperative AMP: 6/102 (6%) vs. 1/101 (1%) 

P=0.03

 Both groups received AMP at induction of 

anesthesia and were redosed intraoperatively (2h)

High 0 0 0 -1 0 0 0 0 Moderate
Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminated by the Centers for Disease Control and Prevention 

and should not be construed to represent any agency determination or policy. 12

Comparison Outcome

Quantity 

and Type of 

Evidence

Findings Starting 

GRADE

Decrease GRADE Increase 

GRADE

GRADE of 

Evidence for 

Outcome

Overall 

GRADE of 

Evidence 

Base

Study QualityConsistencyDirectnessPrecisionPublication BiasLarge MagnitudeDose-responseConfounders

Incisional 

SSI* 1 RCT 28

 No difference: 1/102 (1%) vs. 1/101 (1%); p=0.9 High 0 0 0 -1 0 0 0 0 Moderate

Mortality 1 RCT 28  4 (2%) postoperative deaths; none related to AMP 

or SSI High 0 0 0 -1 0 0 0 0 Moderate

Length of 

stay

1 RCT 28

 No differences: 15±1.6 days versus 13±1 days High 0 0 0 -1 0 0 0 0 Moderate

Adverse 

Events 1 RCT 28  No side effects of the antimicrobial prophylaxis 

were noted High 0 0 0 -1 0 0 0 0 Moderate

Vascular Surgery

None

vs.

<24 hours

SSI* 1 RCT 11

 No difference in 1 RCT subanalysis (N=169) of 

clean, clean-contaminated, and contaminated 

elective and emergency vascular surgery 

procedures: 2/89 (3.8%) vs. 3/80 (2.3%), p>0.05 (1 

month follow up)

High 0 0 0 -1 0 0 0 0 Moderate Moderate

<24h versus

3 days SSI* 1 RCT 29

 No difference in 1 RCT, of patients undergoing 

acute femoral embolectomy or thrombectomy, 

subanalysis (N=121): 2/52 (3.8%) vs. (3/69) 4.3%; 

p=0.89 (30 day follow up)

High 0 0 0 -1 0 0 0 0 Moderate Moderate

None 

vs. 

5 days

SSI* 1 RCT 30

 Reduced risk of SSI with postoperative AMP in 1 

RCT of emergency and elective open arterial 

reconstructions (N=302): 28/153(18%) vs. 

15/149(10%); OR: 2.00; 95% CI: 1.02 – 3.92; 

p=0.04) (42 day follow up).

 Overall SSI rate: 14.2% (43/302). 

High 0 0 0 -1 0 0 0 0 Moderate Moderate
Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminated by the Centers for Disease Control and Prevention 

and should not be construed to represent any agency determination or policy. 13

Comparison Outcome

Quantity 

and Type of 

Evidence

Findings Starting 

GRADE

Decrease GRADE Increase 

GRADE

GRADE of 

Evidence for 

Outcome

Overall 

GRADE of 

Evidence 

Base

Study QualityConsistencyDirectnessPrecisionPublication BiasLarge MagnitudeDose-responseConfounders

 Patients received first dose of AMP (over 30 

minutes) after induction of anesthesia. Patients 

tended to be “elderly and debilitated”, with a 

higher proportion of those in the “no 

postoperative AMP” being current smokers and 

insulin dependent diabetics.

Organ/ 

Space SSI* 1 RCT 30

 No difference: 1 graft infection in each group High 0 0 0 -1 0 0 0 0 Moderate

Ear, nose, and throat (ENT) procedures

≤24h

vs. 

3-5 days

SSI* 2 RCT 31, 32

 No difference on meta-analysis of 2 small RCTs 

(N=127): OR: 1.54 (95% CI: 0.59 – 4.05); p=0.38

 1 RCT 31 of 53 patients undergoing head and neck 

procedures including myocutaneous flap 

reconstruction, reported an overall wound 

infection rate of 24.5% (13/53) at 30 day follow 

up and no difference between groups: 

8/26(30.7%) vs. 5/27(18.5%); p=0.471.

 1 RCT 32 in 74 patients undergoing head and neck 

procedures including immediate flap 

reconstruction, reported an overall wound 

infection rate of 10.8% (8/74) at 7 day follow up 

and no difference between groups 4/35 (11%) vs. 

4/39 (10%); P=0.99 

High 0 0 0 -1 0 0 0 0 Moderate

Moderate

Length of 

stay

1 RCT 31

 No difference: 25±18 vs. 22±15 days; P=0.627 High 0 0 0 -1 0 0 0 0 Moderate
Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminated by the Centers for Disease Control and Prevention 

and should not be construed to represent any agency determination or policy. 14

Comparison Outcome

Quantity 

and Type of 

Evidence

Findings Starting 

GRADE

Decrease GRADE Increase 

GRADE

GRADE of 

Evidence for 

Outcome

Overall 

GRADE of 

Evidence 

Base

Study QualityConsistencyDirectnessPrecisionPublication BiasLarge MagnitudeDose-responseConfounders

Pharyngoc

utaneous 

fistula

1 RCT 32

 No difference: 3/35 (9%) vs. 3/39(8%) (7 day 

follow up).

 Overall pharyngocutaneous fistula rate: 6/74 (8%) 

High 0 0 0 -1 0 0 0 0 Moderate

Gynecologic Procedures

None

vs.

≤24h

SSI* 4 RCT 8, 22, 

23, 24

 No difference on meta-analysis (N=1317) of 4 

RCTs: OR: 1.25; 95% CI: 0.50 – 3.13; p=0.63.

 in 1 RCT 8(N=531) of patients undergoing 

laparoscopic-assisted vaginal hysterectomy (LAVH) 

or ovarian cystectomy (LAOC), total abdominal or 

vaginal hysterectomies (TAH or TVH), 1 trocar site 

infection was reported in each group at 90 day 

follow up: 1/267 vs. 1/264.

 In 1 RCT 22 (N=66) of patients undergoing radical 

gynecologic pelvic surgery for malignancy, 1 

abdominal wound infection was reported in each 

group at 8 day follow up: 1/37 vs. 1/29.

 In 1 RCT 24 with a subpopulation of 608 patients 

undergoing unspecified gynecologic procedures, 

no difference at minimum 7 day follow up: 12/385 

vs.4/223;p=0.53

 In 1 RCT 23 of 112 patients undergoing vaginal 

hysterectomy, no difference: 1/58 vs. 2/54(3-6 

week follow up)

High -1 0 0 -1 0 0 0 0 Low

Low

Organ/spa

ce SSI* 1 RCT 8

 In 1 RCT (N=531) among the 478 who had 

laparoscopic-assisted vaginal hysterectomy 

(LAVH), total abdominal or vaginal hysterectomies 

(TAH or TVH), only 1 vaginal cuff infection with 

pelvic abscess was reported in patient who 

underwent LAVH in the 24 hour group: 0/237 vs. 

High -1 0 0 -1 0 0 0 0 Low
Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminated by the Centers for Disease Control and Prevention 

and should not be construed to represent any agency determination or policy. 15

Comparison Outcome

Quantity 

and Type of 

Evidence

Findings Starting 

GRADE

Decrease GRADE Increase 

GRADE

GRADE of 

Evidence for 

Outcome

Overall 

GRADE of 

Evidence 

Base

Study QualityConsistencyDirectnessPrecisionPublication BiasLarge MagnitudeDose-responseConfounders

1/241 (0.41%) at 90 day follow up.

Trocar 

wound 

infection*

1 RCT 8

 In 1 RCT (N=531), among the 455 (86%) patients 

who had a laparoscopic-assisted vaginal 

hysterectomy (LAVH) or ovarian cystectomy 

(LAOC), only 1 trocar wound infection was 

reported in a patient who underwent LAOC in the 

no postoperative AMP group: 1/226 (0.44%) vs. 

0/229. (90 day follow up)

High -1 0 0 -1 0 0 0 0 Low

Length of 

Stay

3 RCT 8, 22,

23

 One RCT 8no difference : 4.02 ±1.51 vs. 3.97±1.27 

 One RCT 22no differences: 18 days (range 12-23) 

vs. 19 days (range, 12-23 days)

 One RCT 23no difference : days ±SD: 4.4±1.1 vs. 

4.7±1.2 days

High 0 0 0 0 0 0 0 0 High

<24h

vs.

<2.5 days 

SSI* 1 RCT 33

 No difference: 1 RCT (N=156) in patients 

undergoing a laparoscopic-assisted vaginal 

hysterectomy (LAVH) no difference: 2/74(2.7%) vs. 

3/82(3.6%) (7 day follow up)

 Overall SSI rate: 3.2% (5/156) 

High 0 0 0 -1 0 0 0 0 Moderate

Moderate

Organ/ 

Space SSI* 1 RCT 33  No difference 1 vaginal cuff abscess in each group. 

(7 day follow up). High 0 0 0 -1 0 0 0 0 Moderate
Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminated by the Centers for Disease Control and Prevention 

and should not be construed to represent any agency determination or policy. 16

Comparison Outcome

Quantity 

and Type of 

Evidence

Findings Starting 

GRADE

Decrease GRADE Increase 

GRADE

GRADE of 

Evidence for 

Outcome

Overall 

GRADE of 

Evidence 

Base

Study QualityConsistencyDirectnessPrecisionPublication BiasLarge MagnitudeDose-responseConfounders

Trocar

wound 

infection

1 RCT 33  No difference: 1/74 (1.4%) vs. 3/82(3.7%); P=0.38. 

(7 day follow up) High 0 0 0 -1 0 0 0 0 Moderate

Orthopaedic Surgery – Fracture Surgery

None

vs.

≤24h

SSI* 4 RCT 9, 12, 

14, 13

 No difference on meta-analysis of 4 RCTs 

(N=1722): OR: 1.87; 95% CI: 0.70 – 4.94; p=0.21

 3 RCTs 9, 12, 14 reported no difference between 

groups for all SSIs combined:

 One RCT 9(N=191) in hip fracture patients 

reported a total of 4 (2.1%) infections and no 

difference between groups at 6w follow up: 

2/83(2.4%) vs. 2/108(1.9%); p=0.79. Both were 

superficial SSI. Postop dosing group received AMP 

for another 24h. 

 1 RCT 12 (N=200) in a mix of clean orthopaedic 

fracture surgeries reported a total of 14(7%) 

infections, and no difference between groups at 

28day follow up: 8% vs. 6%; p=0.27 Postop dosing 

group received AMP for another 24h. 

 1 RCT 14 (N=614) in orthopaedic fracture fixation 

and arthroplasty patients, no difference: 2/301 

(0.66%) vs. 3/313(1.27%); p=0.45 (10 day follow 

up); Overall SSI rate0.98%. 

 1 RCT 13 (N=717) in a mix of orthopaedic fracture 

surgeries, reported a total of 23(3.2%) infections 

(follow up period not reported) with a significantly 

higher risk of SSI among the no postoperative 

AMP group : 20/382(5.3%) vs. 3/335(0.89%); 

p=0.004 This significance was seen for both 

High 0 0 0 -1 0 0 0 0 Moderate Moderate
Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminated by the Centers for Disease Control and Prevention 

and should not be construed to represent any agency determination or policy. 17

Comparison Outcome

Quantity 

and Type of 

Evidence

Findings Starting 

GRADE

Decrease GRADE Increase 

GRADE

GRADE of 

Evidence for 

Outcome

Overall 

GRADE of 

Evidence 

Base

Study QualityConsistencyDirectnessPrecisionPublication BiasLarge MagnitudeDose-responseConfounders

hemiarthroplasties: 5/76 (6.5%) vs. 0/74(0%); 

p=0.03 and all other procedures combined: 

15/306 (5%) vs. 3/261(1%); p=0.006. 

Postoperative dosing group received AMP for 

another 20h postop. Patients in both groups were 

hospitalized for approximately 5 days before 

surgery.

Deep SSI* 2 RCT 9, 12

 No difference on meta-analysis of 2 RCTs (N=391): 

OR: 0.33; 95% CI: 0.03 – 3.19; p=0.34.

 One RCT 9(N=191) in hip fracture patients 

reported no deep infections in either group (0/83 

vs. 0/108) at 6 week follow up. 

 1 RCT 12 (N=200) in a mix of clean orthopaedic 

fracture surgeries reported a total of 4(2%) deep 

infections and no difference between groups at 28 

day follow up: 1% vs. 3%; p=0.34 

High 0 0 0 -1 0 0 0 0 Moderate

Superficial 

SSI* 2 RCT 9, 12

 No difference in meta-analysis of 2 RCT (N=391), 

no difference between groups (OR: 1.99; 95% CI: 

0.64 – 6.17; p=0.24)

 1 RCT 9(N=191) in hip fracture patients reported a 

total of 4 (2.1%) infections and no difference: 

2/83(2.4%) vs. 2/108(1.9%); p=0.79 (6 week 

follow up): 

 1 RCT 12 (N=200) in a mix of clean orthopaedic 

fracture surgeries reported a total of10 (5%) 

superficial SSIs and no difference:: 7% vs. 3%; 

p=0.21 (28 days follow up)

High 0 0 0 0 0 0 0 0 High

Mortality 2 RCT 9, 13

 In 1 RCT 9(N=191), there were 7 (3.4%) deaths. 

There were no significant differences in mortality 

between groups 3/121(2.4%) vs. 4/83 (4.81%) and 

High 0 0 0 0 0 0 0 0 High
Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminated by the Centers for Disease Control and Prevention 

and should not be construed to represent any agency determination or policy. 18

Comparison Outcome

Quantity 

and Type of 

Evidence

Findings Starting 

GRADE

Decrease GRADE Increase 

GRADE

GRADE of 

Evidence for 

Outcome

Overall 

GRADE of 

Evidence 

Base

Study QualityConsistencyDirectnessPrecisionPublication BiasLarge MagnitudeDose-responseConfounders

no deaths resulted from infections.

 In 1 RCT 13 (N=717) there were 30 deaths (4%); 1 

patient had an uncontrolled wound infection but 

the cause of death was a stroke.

Adverse 

Events 1 RCT 9

 In 1 RCT (N=191), there were no anaphylactic 

reactions, allergies or renal toxicity related to 

antimicrobial prophylaxis administration.

High 0 0 0 -1 0 0 0 0 Moderate

Antimicro

bial 

resistance

3 RCT 9,12,13

 In 1 RCT 9(N=191), Staphylococcus aureus isolated 

from all SSIs. No gram negative organisms 

isolated. No mention of antimicrobial resistance.

 In 1 RCT 12 (N=200) Staphylococcus aureus was the 

commonest organism isolated, followed by E.coli. 

Eight of the 14 SSIs had a negative wound culture 

(7 superficial, 1 deep). No mention of resistance

 In 1 RCT 13(N=717) 31 organisms isolated from 23 

wound infections: 9 Staphylococcus aureus, 4 S. 

epidermis and 4 E.coli all sensitive to the AMP. In 

addition, 4 Pseudomonas aeruginosa, and 3 

Streptococcus faecalis all resistant to the AMP and 

7 strains of other gram negative bacilli, 2 of them 

resistant to the AMP.

High 0 0 0 0 0 0 0 0 High

Orthopaedic Surgery-Prosthetic Joint Arthroplasty)

None

vs.

≤ 24h

SSI* 2 RCT 16, 15

 No difference in a meta-analysis of 2 RCT, no 

difference between groups (OR: 1.84; 95% CI: 0.68 

– 4.98; p=0.23)

 In the larger RCT 15 (N=2651) in THA, TKA, and 

hemiarthroplasty patients, no difference in PJI 

between groups at 13 month follow up: 11/1327 

(0.83%) vs. 6/1324(0.45%); p=0.17; RR: 1.83, 

High 0 0 0 0 0 0 0 0 High High
Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminated by the Centers for Disease Control and Prevention 

and should not be construed to represent any agency determination or policy. 19

Comparison Outcome

Quantity 

and Type of 

Evidence

Findings Starting 

GRADE

Decrease GRADE Increase 

GRADE

GRADE of 

Evidence for 

Outcome

Overall 

GRADE of 

Evidence 

Base

Study QualityConsistencyDirectnessPrecisionPublication BiasLarge MagnitudeDose-responseConfounders

95%CI (0.68-4.93). 

 In the second smaller study 16 (N=196), in 

unilateral or bilateral THA or TKA patients no 

infections (including deep wound infections) were 

reported in either group at 12month follow up.

Colorectal Surgery

BOWEL PREPARATION INCLUDED ORAL ANTIMICROBIALS PREOPERATIVELY

None

vs.

3 days

SSI* 

Incisional 1 RCT 34

 No difference in 1 RCT (N=360) in patients 

undergoing elective laparotomy for colorectal 

malignancy: 15/179 (8.4%) vs. 13/181(7.2%); 

p=0.67 (30 day follow up) 

High 0 0 0 -1 0 0 0 0 Moderate

Moderate

SSI* 

Organ/ 

Space

1 RCT 34

 No difference: 1/179(0.6%) vs. 2/181(1.1%); 

p=0.58 (30 day follow up)

 All 3 caused by anastomotic leak

High 0 0 0 -1 0 0 0 0 Moderate

Antimicro

bial 

resistance

1 RCT 34

 Culture isolates available for 23/28 patients with 

incisional SSI: Pseudomonas aeruginosa most 

commonly isolated in both groups followed by 

Enterococcus faecalis. MRSA isolated from 3 

patients all in the group without postoperative 

administration of AMP (in 2 as part of 

polymicrobial SSI).

High 0 0 0 -1 0 0 0 0 Moderate

Adverse 

events

1 RCT 34

 No Clostridium difficile in either group High 0 0 0 -1 0 0 0 0 Moderate
Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminated by the Centers for Disease Control and Prevention 

and should not be construed to represent any agency determination or policy. 20

Comparison Outcome

Quantity 

and Type of 

Evidence

Findings Starting 

GRADE

Decrease GRADE Increase 

GRADE

GRADE of 

Evidence for 

Outcome

Overall 

GRADE of 

Evidence 

Base

Study QualityConsistencyDirectnessPrecisionPublication BiasLarge MagnitudeDose-responseConfounders

≤24h 

vs.

5 days

SSI* 1 RCT 35

 1 RCT (N=40) in patients with chronic ulcerative 

colitis, familial polyposis or Gardner’s syndrome 

undergoing colectomy, mucosal proctectomy with 

ileal pouch-anal anastomosis reported no wound 

or intra-abdominal infections in either group at 

1yr follow up: 0/22 vs. 0/18.

High 0 0 0 -2 0 0 0 0 Low

Low

Length of 

stay

1 RCT 35  No difference: (mean±SD) 8.7±0.4 days vs. 8.4±0.2 

days. High 0 0 0 -1 0 0 0 0 Moderate

BOWEL PREPARATION ONLY 

None 

vs.

<24h

SSI* 4 RCT 10, 18, 

19, 17

 No difference In a meta-analysis of 4 RCTs, no 

difference between groups (OR: 1.58; 95% CI: 0.76 

– 3.28; p=0.22)

 1 RCT 10 (N=377) in elective open and 

laparoscopic colorectal procedures for colon 

cancer postoperative AMP associated with 

reduced risk of SSI at 30 day follow up: 

27/190(14.2%) vs. 8/187(4.3%);p=0.009. On 

multivariate analysis antimicrobial dose was the 

only significant factor associated with incisional 

SSI (p=0.002).

 1 RCT 17 1 subgroup analysis 1 (N=138) in patients 

undergoing elective colorectal procedures 

suggests no difference: 12/138 (8.7%); 5/71(7.0%) 

vs. 7/67(10.4%); p =0.48 (28-41 day follow up)

 1 RCT 17 subgroup analysis 2 (N=135) in patients 

High 0 0 0 0 0 0 0 0 High High
Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminated by the Centers for Disease Control and Prevention 

and should not be construed to represent any agency determination or policy. 21

Comparison Outcome

Quantity 

and Type of 

Evidence

Findings Starting 

GRADE

Decrease GRADE Increase 

GRADE

GRADE of 

Evidence for 

Outcome

Overall 

GRADE of 

Evidence 

Base

Study QualityConsistencyDirectnessPrecisionPublication BiasLarge MagnitudeDose-responseConfounders

undergoing elective colorectal procedures 

suggests no difference: 16/135 (11.9%); 

8/65(12.3%) vs. 8/70(11.4%); p=0.87 (28-41 day 

follow up)

 1 RCT 19 (N=154) in elective colorectal procedures 

suggests no difference: 40/77(5.2%) vs. 

40/77(5.2%); Follow up NR

 1 RCT 18 (N= 90) in elective colorectal procedures, 

excluding inflammatory bowel disease, suggest no 

difference for abdominal (18/90(20%): 7/22 (31%) 

vs. 11/68(16%); p=0.12) or perineal wounds: 1/3 

(33.3%) vs. 7/13 (53.8%); p=0.53. (6 week follow 

up).

Organ/spa

ce SSI* 2 RCT 10, 19

 No difference in a meta-analysis (N=531) of 2 RCTs

(OR: 0.73; 95% CI: 0.30 – 1.77; p=0.49)

 One RCT 10no difference: 5/190 (2.6%) vs. 

9/187(4.8%); p=0.26. (30 day follow up)

 One RCT 19no difference for intra-abdominal 

abscess 2/77(2.6%) vs. 1/77(1.3%); p=0.57 or 

peritonitis 2/77(2.6%) vs. 2/77(2.6%); Follow up 

NR

High 0 0 0 0 0 0 0 0 High

None

vs. 

<2 – 3 days

All SSI* 3 RCT 36, 37, 

38

 No difference in a meta-analysis of 3 RCTs: OR 

1.35 (95% CI: 0.70 – 2.61); p=0.37

 1 RCT 36 with subanalysis in elective colorectal 

procedures (n=207) suggests no difference 

between groups at 35 day follow up: 

11/102(10.7%) vs. 6/105(5.6%); p=0.19

 1 RCT 37 (N=443) in elective colorectal procedures 

for cancer, inflammatory bowel disease (10%), 

and other (10%) suggests no difference between 

High 0 0 0 0 0 0 0 0 High Moderate
Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminated by the Centers for Disease Control and Prevention 

and should not be construed to represent any agency determination or policy. 22

Comparison Outcome

Quantity 

and Type of 

Evidence

Findings Starting 

GRADE

Decrease GRADE Increase 

GRADE

GRADE of 

Evidence for 

Outcome

Overall 

GRADE of 

Evidence 

Base

Study QualityConsistencyDirectnessPrecisionPublication BiasLarge MagnitudeDose-responseConfounders

groups for deep wound infections: 17/294 (5.8%); 

9/149 (6%) vs. 8/145 (6%) or for intra-abdominal 

abscess: 3/294 (1.0%); 1/149 (1%) vs. 2/145 (1%) 

at 30 day follow up.

 1 RCT 38 (N=100) in elective colorectal procedures 

for cancer or diverticulitis suggests no difference 

between groups: 3/100 (3.0%); 2/54 (3.7%) vs. 

1/46 (2.1%); p=0.66 (Follow up NR)

Organ/Sp

ace* 1 RCT 37  No difference: 1/149 (1%) vs. 2/145 (1%)

 Overall Organ/Space SSI rate: 3/294 (1.0%) High 0 0 0 -1 0 0 0 0 Moderate

Antimicro

bial 

Resistance

2 RCT 37, 38  No difference in bacterial isolates and no report 

of antimicrobial resistance High 0 0 0 -1 0 0 0 0 Moderate

BOWEL PREPARATION NOT REPORTED

None

vs.

≤24h

SSI* 1 RCT 20

 No difference for colorectal cases in 1 RCT 

(N=224) in at-risk abdominal surgery : 

40/224(17.9%); 23/113(20.4%) vs. 17/111(15.3%); 

P>0.2 (30 day follow up)

High 0 0 0 --1 0 0 0 0 Moderate Moderate

≤24h 

vs. 

2-3 days

SSI* 4 RCT 39, 40, 

41, 42

 No difference in a meta-analysis of 4 RCT, (N=802) 

no difference between groups (OR: 1.13; 95% CI: 

0.75 – 1.70; p=0.57)

 1 RCT 39 (N=87) colorectal surgery suggests no 

difference : 20/87 (23.0%); 13/45(28.9%) vs. 

7/42(16.7%); p=0.18 (28 day follow up)

 1 RCT 40 with subanalysis (n=428) in high-risk 

colorectal procedures suggests no difference: 

45/428 (11%); 22/209(11%) vs. 23/219(11%); 

p=0.99 (30 day follow up)

High 0 0 0 0 0 0 0 0 High High
Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminated by the Centers for Disease Control and Prevention 

and should not be construed to represent any agency determination or policy. 23

Comparison Outcome

Quantity 

and Type of 

Evidence

Findings Starting 

GRADE

Decrease GRADE Increase 

GRADE

GRADE of 

Evidence for 

Outcome

Overall 

GRADE of 

Evidence 

Base

Study QualityConsistencyDirectnessPrecisionPublication BiasLarge MagnitudeDose-responseConfounders

 1 RCT 41 (N=60) in elective colon surgery no 

difference: 6/30 (20%) vs. 10/30 (33.3%); p=0.25

 1 RCT 42 in elective colorectal surgery subanalysis 

(n=227) no difference in abdominal wound: 

23/113 (19.5%) vs. 22/114 (19.3); p=0.84; perineal 

wound: 7/113 (6.2%) vs. 3/114 (2.6%);p=0.20

Organ/ 

Space* 3 RCTs 40, 41, 

42

 No difference in a meta-analysis (N=715) of 3 

RCTs: (OR: 0.77; 95% CI: 0.37 – 1.63; p=0.50) 

 1RCT 40 Intra-abdominal abscess: No difference: 

14/428 (3%) total; 6/209 (3%) vs. 8/219 (4%); 

p=0.65 (30 day follow up)

 1RCT 41 Intra-abdominal abscess no difference:): 

2/30 (7%) vs. 2/30 (7%); Peritonitis no difference:

1/30 (3%) vs. 3/30 (10%); p=0.32 (follow up NR)

 1 RCT 42 Intrapelvic abscess no difference: 2/113 

(1.8%) vs. 2/114 (1.8%); Intra-abdominal abscess 

no difference: 2/113 (1.8%) vs. 1/114 (0.9%); 

p=0.56; Peritonitis no difference: 0/113 vs. 1/114 

(0.9%)

High -0 0 0 0 0 0 0 0 High

Adverse 

events

1 RCT 42

 Adverse events possibly related to antimicrobial 

agent included 2 patients with phlebitis in the 

group receiving <24 AMP and in the group 

receiving longer AMP 2 cases of hypotension, 1 

phlebitis, 1 erythema, and 1 rash

High 0 0 0 -1 0 0 0 0 Moderate

NO BOWEL PREPARATION

None

vs.

≤24h

SSI* 1 RCT 17

 No difference in 1 RCT subpopulation (n=46) of 

emergency colorectal procedures: 6/46 (13.0%); 

4/21 (19.0%) vs. 2/25 (8.0%); p=0.28 (28-42 day 

follow up)

High 0 0 0 -1 0 0 0 0 Moderate Moderate
Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminated by the Centers for Disease Control and Prevention 

and should not be construed to represent any agency determination or policy. 24

Comparison Outcome

Quantity 

and Type of 

Evidence

Findings Starting 

GRADE

Decrease GRADE Increase 

GRADE

GRADE of 

Evidence for 

Outcome

Overall 

GRADE of 

Evidence 

Base

Study QualityConsistencyDirectnessPrecisionPublication BiasLarge MagnitudeDose-responseConfounders

None 

vs.

<2 – 3 days

SSI* 1 RCT 36

 No difference in 1 RCT subpopulation (n=38) of 

emergency colorectal procedures: 1/17(5.8%) vs. 

4/21(20.0%); p=0.26 (35 day follow up)

High 0 0 0 -1 0 0 0 0 Moderate Moderate

General Surgery - OTHER

Appendectomy

None 

vs. 

≤24h 

SSI* 3 RCT 6, 20, 

17

 No difference in a meta-analysis of 3 RCTs 

(N=662): OR:0.79 (95% CI: 0.45 – 1.42); p=0.43 

 One study 6of emergency non-perforated open 

appendectomies, reported no difference in 

incisional wound infections between groups: 

6/92(6.5%) vs. 6/94(6.4%) at 30 day follow. No 

deep incisional or organ/space infection were 

reported in either group.

 1 RCT 20 with subpopulation of appendectomies 

(n=247): 11/114 (9.6%) vs. 21/133(15.8%); p=0.16

 Drug regimen 1 17: n=112: 4/54 vs. 4/58

 Drug regimen 2 17: n=117 2/63 vs. 0/54

High 0 0 0 0 0 0 0 0 High High 

None 

Vs.

2 days

SSI* 1 RCT 36

 Increased risk of SSI with 2 days postoperative 

AMP: 1 RCT subpopulation of appendectomies 

(n=246): 3/127 (2.3%) vs. 10/119 (8.4%); p<0.05

High 0 0 0 -1 0 0 0 0 Moderate Moderate

Rectal surgery

None

vs.

≤24h

SSI* 1 RCT 21

 No difference in 1 RCT subanalysis of 48 elective 

rectal surgery patients: 2/19(10.5%) vs. 

1/29(3.4%); p=0.35. (1 month follow up)

 Number of events is small

High 0 0 0 --1 0 0 0 0 Moderate Moderate

Gastric Surgery

None

vs. 

≤24h

Organ/

space* 1 RCT 21

 No difference in 1 RCT with subanalysis gastric 

procedures (n=64) including gastrectomy (n=8), 

gastric banding (n=35) and other gastric (n=21) 

High 0 0 0 -1 0 0 0 0 Moderate Moderate
Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminated by the Centers for Disease Control and Prevention 

and should not be construed to represent any agency determination or policy. 25

Comparison Outcome

Quantity 

and Type of 

Evidence

Findings Starting 

GRADE

Decrease GRADE Increase 

GRADE

GRADE of 

Evidence for 

Outcome

Overall 

GRADE of 

Evidence 

Base

Study QualityConsistencyDirectnessPrecisionPublication BiasLarge MagnitudeDose-responseConfounders

reported deep surgical sepsis: 1/24 (4%) vs. 4/40 

(10%); p=0.41

None 

vs.

4 days

SSI* 1 RCT 43

 No difference in 1 RCT of elective gastric surgery 

for gastric cancer (excluded colorectal surgery): 

23/243 (9.5%) vs. 21/243(8.6%) p=NS. (30 day 

follow up)

 Overall SSI rate of 9.1% (44/486) 

High 0 0 0 -1 0 0 0 0 Moderate

Moderate

Organ/ 

Space SSI*

1 RCT 

(293243)

 No difference: 12/243(4.9%). Vs. 10/243(4.1%) 

p=NS High 0 0 0 -1 0 0 0 0 Moderate

Incisional 

SSI 1 RCT 43  No difference: 14/243(5.8%) vs. 11/243(4.5%); 

P=NS High 0 0 0 -1 0 0 0 0 Moderate

Antimicro

bial 

Resistance

1 RCT 43

 No difference in isolate resistance patterns. High 0 0 0 -1 0 0 0 0 Moderate

Hepatectomy

2 days vs.

5 days

SSI* 1 RCT 44

 No difference in 1 RCT (N=180) in hepatectomies: 

4/89(4.5%) vs. 4/91(4.4%); 14 day follow up

 Overall SSI rate: 4.4% (8/180)

High 0 0 0 -1 0 0 0 0 Moderate

Moderate Organ/ 

Space SSI* 1 RCT 44

 No difference: 2/89(2.2%) vs. 3/91(3.3%); p=0.67 High 0 0 0 -1 0 0 0 0 Moderate

Incisional 

SSI 1 RCT 44

 No difference: 2/89(2.2%) vs. 1/91(1.1%); p=0.56 High 0 0 0 -1 0 0 0 0 Moderate

*Critical outcome; OR: Odds Ratio; RR: Risk Ratio; CI: Confidence Interval
Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminated by the Centers for Disease Control and Prevention 

and should not be construed to represent any agency determination or policy. 26
Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminated by the Centers for Disease Control and Prevention 

and should not be construed to represent any agency determination or policy. 27

EVIDENCE TABLE Q1

Q1. What are the most effective strategies for administering parenteral AMP to reduce the risk of SSI? 

A. What is the optimal timing of preoperative AMP? Our search did not identify RCTs or SRs that evaluated different 

timings of preoperative AMP administration and its impact on the risk of SSI.

B. What is the optimal timing of AMP in cesarean section: prior to skin incision or at cord clamping?

Author

Year

(Data 

Extractor)

Risk of 

Bias

Score

Study Objective Population and Setting Intervention Results Comments

Costantine 

20081(RA)

SR

1, 3, 7, 

8, 9, 10

To summarize 

the available 

evidence on 

timing of 

perioperative 

antimicrobials

for cesarean 

delivery

Study types: RCT

N: 3 RCT, 749 

participants. (2 non RCTs 

were also reported in 

tables, although their 

data were not analyzed

Inclusion criteria: Studies 

that compared timing of 

prophylactic 

antimicrobials that were 

given at cord clamping vs. 

preoperatively during 

cesarean delivery. Only 

English studies were 

included. 

Exclusion criteria: None

Databases searched:

PubMed (searches ended 

July 2007)

Quality assessment: All 3 

RCTs had adequate 

allocation concealment. 

All of the RCTs had a 

Intervention: Antimicrobial

(cefazolin) prophylaxis given 

before skin incision

Comparison: Antimicrobial

(cefazolin) prophylaxis given 

after cord clamping

Standard preventive 

measures: NR

SSI:

All results for intervention vs. 

control – RR(95% CI). No 

significant heterogeneity 

unless specified.

Maternal outcomes:

Endometritis (3 studies): 

0.47(0.26-0.85)

Wound infection (3 studies): 

0.60(0.30-1.21)

Total infectious morbidity (3 

studies): 0.50(0.33-0.78)

Fetal outcomes:

Neonatal sepsis (3 studies): 

0.93(0.45-1.96)

Sepsis workup (3 studies): 

1.00(0.70-1.42)

Neonatal Intensive Care Unit 

(NICU) admission (2 studies): 

1.07(0.51-2.24)

No significant heterogeneity 

was seen between trials

No publication bias was 

found by Funnel plots and 

Begg’s test

Definitions: NR 

Perioperative care: 

NR

Other notes: None

Follow up: Follow-up 

perioperatively
Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminated by the Centers for Disease Control and Prevention 

and should not be construed to represent any agency determination or policy. 28

Author

Year

(Data 

Extractor)

Risk of 

Bias

Score

Study Objective Population and Setting Intervention Results Comments

central randomization 

process. 

C. How safe and effective is weight-adjusted AMP dosing? Our search did not identify RCTs or SRs that evaluated weightadjusted AMP dosing and its impact on the risk of SSI. 

D. How safe and effective is intraoperative redosing of AMP?

Author

Year

(Data 

Extractor)

Study 

Design

Quality 

Score

Study Objective Population and Setting Intervention Results Comments

Cuthbertso

n

19915

(ES)

RCT

1, 2, 4, 

7

To determine 

whether a 

double dose of 

intravenous 

Timentin 

provides 

superior 

prophylaxis 

with respect to 

postoperative 

wound 

infection 

compared with 

a single dose, 

they performed 

a controlled 

clinical trial in 

patients 

undergoing 

Number of patients 

N=278

Patient Characteristics: 

there were no 

statistically significant 

differences between 

groups.

Procedures: Abdominal 

operations where the 

bowel was opened.

Setting: 11 hospitals

Location: Australia

Dates: NR

Inclusion Criteria: 

patients undergoing 

elective abdominal 

operations in which 

the bowel was 

opened.

Intervention group: n=132

Patients who received 2 

doses of 3.1g of timentin. 

1 intravenously just 

before incision the other, 

2 hours after the 

beginning of the 

operation.

Timing of intervention: pre 

and intra/post op

Duration of intervention: 2h 

after the beginning of the 

operation.

Device/agent: Timentin 3.1g

Control group: n=146

Patients received a single 

dose of timentin of 3.1g 

intravenously just before 

incision.

SSI:

Intra-abdominal abscess:

2doses: 10/132(8%)

1dose: 8/146 (5%) vs.

Perineal wound infection:

2doses: 4/9 

1dose: 4/9

Antimicrobial Resistance:

No difference: 1 minor SSI in 

each group culture 

positive for MRSA as the 

sole organism

Definitions: 

Wound infection: if 

there was a 

purulent 

discharge from 

the suture line or 

if there was a 

non-purulent 

discharge that 

contained 

pathogenic 

bacteria.

Perioperative care: 

NR 

Other notes: None

Follow-up: 30 days
Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminated by the Centers for Disease Control and Prevention 

and should not be construed to represent any agency determination or policy. 29

Author

Year

(Data 

Extractor)

Study 

Design

Quality 

Score

Study Objective Population and Setting Intervention Results Comments

elective 

colorectal 

surgery.

Exclusion Criteria: 

Patients known to be 

allergic to penicillin or 

who had received 

antimicrobials in the 

72 hours before their 

planned operation. 

Patients were 

excluded if the large 

bowel was not opened 

at operation, if intraabdominal pus was 

found at operation, if 

a stoma or mucous 

fistula was brought 

out through the main 

abdominal wound 

and/or if the main 

abdominal wound was 

not closed primarily.

Standard preventive 

measures: The bowel was 

mechanically cleansed

preoperatively and no 

oral antimicrobials were 

administered.
Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminated by the Centers for Disease Control and Prevention 

and should not be construed to represent any agency determination or policy. 30

E. How safe and effective is postoperative AMP and what is the optimal duration?

Author

Year

(Data 

Extractor)

Study 

Design

Quality 

Score

Study Objective Population and Setting Intervention Results Comments

Suzuki 

201134

(ES)

RCT

1, 2, 7, 

8, 9

To establish the 

optimal 

duration of 

perioperative 

antimicrobial 

administration 

of an 

oxacephem 

antimicrobial in 

patients 

undergoing 

elective colon 

cancer surgery, 

by determining 

the incidence of 

SSIs with the 

use of 

mechanical 

preparation 

and chemical 

preparation 

together with 

oral 

antimicrobial 

administration.

Number of patients: 

N=360

Patient Characteristics: 

No significant 

difference was 

observed in baseline 

patient characteristics 

between groups.

·Age

 Intervention 65±11 

years

 Control: 66±9 years.

·Gender m/f

 Intervention: 101/84

 Control: 101/84

·Obesity

·Comorbidities:

Diabetes

 Intervention: 17/185 

(9.2%)

 Control: 14/185 (7.6%)

Procedures: Elective 

laparotomy for colon 

cancer

Indications: colon cancer

T Category

Tis, T1/ T2-T4

 Intervention: 21/164

 Control: 29/156

TNM Classification: not

significant; 

Setting: 1 university 

hospital

Location: Japan

Intervention group: n=179

A single dose of oxacephem

(1g) antimicrobial 

prophylaxis was 

administered 

intravenously before 

surgery. The antimicrobial 

was given from 1 hour 

before the incision was 

made. When the 

operative time exceeded 

3 hours, an addition al 

gram of antimicrobial was 

administered

Timing of intervention: Pre 

and intraoperatively

(based on procedure 

duration) Duration of 

intervention: Pre and 

intraoperatively (vs. up to 

4 days in controls)

Device/agent: oxacephem 1g 

IV antimicrobial

Monitoring intervention: NR 

(Cultures of drainage or 

purulence were made)

Control group: n=181

Oxacephem (1g) 

antimicrobial was 

administered 

intravenously twice daily 

for 4 days from the day of 

surgery until post-op day 

3. The antimicrobial was 

SSI: (follow up 4 weeks)

Incisional SSI

 Intervention: 15/179 (8.4%)

 11/15: No fever and were 

improved by removal of 

some sutures and abscess 

drainage

 2/15: Developed fever 

and were treated by 

antimicrobials & abscess 

drainage

 Control: 13/181 (7.2%)

 13/13: No fever and were 

improved by removal of 

some sutures and abscess 

drainage

 P=0.0008 (Δ=0.10)

Organ/ space SSI

 Intervention: 1/179 (0.6%)

 Control: 2/181 (1.1%)

 P<0.001 (Δ=0.10)

 3/3: anastomic leakage

Other infections:

Remote Infection

 Intervention: 8/179 (4.5%)

 6/8: Catheter infection

 Detected Post-OP 

day 3 or later & resolved 

with catheter 

removal & antimicrobial 

administration

 1/8: Jugular vein 

phlebitis

Definitions: 

Postoperative 

infection: an 

infection 

occurring within 

30 days after 

surgery. 

SSI: diagnosed by ≥2 

physicians

Incisional SSI: 

macroscopic 

abscess or 

purulent 

discharge 

observed on the

operative wound

Organ/ space SSI: An 

infection in the 

organ subjected 

to surgery.

Remote infection:

Evaluated by 

chest plain films, 

sputum, urine, 

blood, or catheter 

culture after 

surgery.

Perioperative care:

NR

Other notes: Noninferiority margin 

is 10% (Δ=0.10). 

Based on this, 

there were no 
Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminated by the Centers for Disease Control and Prevention 

and should not be construed to represent any agency determination or policy. 31

Author

Year

(Data 

Extractor)

Study 

Design

Quality 

Score

Study Objective Population and Setting Intervention Results Comments

Dates: August 2002-

October 2007

Inclusion Criteria: 

Patients undergoing 

elective laparotomy 

for colon cancer

Exclusion Criteria: 

Patients with stoma, 

those who could not 

undergo the normal 

mechanical 

preparation owing to 

stenosis or 

obstruction, and those 

with a preoperative 

diagnosis of stage IV 

and American Society 

of Anesthesiologists 

score of ≥3. 

given from 1 hour before 

the incision was made. 

When the operative time 

exceeded 3 hours, an 

addition al gram of 

antimicrobial prophylaxis

was administered

Standard preventive 

measures:

Bowel Prep: All patients 

underwent mechanical 

and chemical preparation 

of the bowel.

1. Mechanical: 10 ml 

of sodium 

picosulfate was 

orally administered 

2 days before 

surgery and 2,000 

ml of polyethylene 

glycol-electrolyte 

sodium was orally 

administered in the 

morning of the day 

before surgery

2. Chemical: 0.5g of 

kanamycin sulfate 

and 0.5g of 

metronidazole were 

orally administered 

at 1, 2 and 11pm on 

the day before the 

operation.

 1/8: Pneumonia

 Control: 6/181 (3.3 %)

 4/6: Catheter infection

 Detected Post-OP 

day 

 5 or later & 

resolved 

 with catheter 

 removal & abx

 1/6: Urinary Tract 

Infection

 1/6: Pneumonia

 P<0.0001 (Δ=0.10)

C. difficile Colitis

 Intervention: 0/179

 Control: 0/181 

Topic-specific outcomes: NA

Reoperations: 

3/3 Organ/ space SSI 

developed fever and 

required reoperation

Length of stay:

Mean Length of stay for 

patients with colon 

cancer: 15±4 days (facility 

data)

Mortality: NR

Adverse events:

Small Bowel Obstruction

 Intervention: 5/179 (2.8%)

 Control: 8/181 (4.4 %)

 P<0.0001 (Δ=0.10)

Other

 Intervention: 2/179 (1.1%)

 1/2: Venous thrombosis 

differences in 

incidence of SSIs, 

organ/space or 

remote infections 

between groups 

(single dose vs. 

postop dosing X 

up to 4 days)

Follow-up: 4 weeks 

post-discharge at 

a hospital visit. 
Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminated by the Centers for Disease Control and Prevention 

and should not be construed to represent any agency determination or policy. 32

Author

Year

(Data 

Extractor)

Study 

Design

Quality 

Score

Study Objective Population and Setting Intervention Results Comments

of the lower extremities

 1/2: Duodenal Stenosis

 Control: 2/181 (1.1 %)

 1/2: Postoperative 

hemorrhage

 1/2: Duodenal Stenosis

Tamayo 

20087

(ES)

RCT

1, 2, 4, 

7, 8, 9 

To test the 

hypothesis that 

single doses of 

cefazolin are as

effective as a 

24-hour 

regimen of 

cefazolin in 

preventing SSIs 

in adults 

undergoing 

cardiac 

procedures

Number of patients: 

N=838

Patient Characteristics: 

Both groups were 

homogeneous and 

comparable in as far 

as their demographic 

profiles and clinical 

characteristics were 

concerned except for 

transfusions (below).

·Age(y) (mean±SD)

 Intervention: 67.5±10.5

 Control: 68.2±10.5

·Gender (m/f)

 Intervention: 272/147

 Control: 247/172

 P=0.07

·Obesity: NR

·Comorbidities

Diabetes: n (%)

 Intervention: 111 

(26.5%)

 Control: 125 (29.8%)

Peripheral Vascular 

Disease

Intervention group: n=419

A single dose of 2g cefazolin 

was administered 

intravenously between 

20-30 minutes after the 

induction of anesthesia. . 

For all procedures lasting 

more than 3 hours, a new 

dose of 1g of cefazolin 

was administered

intraoperatively.

Timing of intervention: 

Single dose 

preoperatively (re-dosed 

intraoperatively 

depending on procedure 

duration)Duration of 

intervention: Pre and 

intraop vs. extended 

dosing X 24hrs postop in 

controls

Device/agent: Cefazolin 2g 

IV

Monitoring intervention: 

Wound cultures 

Control group: n=419

SSI: (Follow up at least 1 

year)

Total SSIs: 50/838 (5.9%)

 Intervention: 30/419 (8.3%)

 Control: 15/419 (3.6%)

 P=0.004

Total Incisional SSI [n (%)]

 Intervention: 21 (5.0%)

 Control: 7 (1.7%)

 P=0.007

 Superficial Incisional SSI [n 

(%)]

 Intervention: 16 (3.8%)

 Control: 7 (1.7%)

 P=0.04

 Deep Incisional SSI [n (%)]

 Intervention: 5 (1.2%)

 Control: 0 

 P=0.03

Organ Space SSI

 Intervention: 14 (3.3%)

 Mediastinitis and 

endocarditis were 

documented 

simultaneously in 2 

patients

Definitions: 

CDC definitions were 

used throughout.

Superficial SSI – The 

infection covers 

the skin and 

subcutaneous 

cellular tissue and 

is accompanied by 

one of the 

following: 

purulent drainage

through the 

incision, positive 

results of the 

incisional culture, 

and classic 

inflammatory 

signs that allow 

the wound to be 

opened by the 

surgeon except in 

cases in which the 

incisional culture 

was negative.

Deep incisional SSI –
Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminated by the Centers for Disease Control and Prevention 

and should not be construed to represent any agency determination or policy. 33

Author

Year

(Data 

Extractor)

Study 

Design

Quality 

Score

Study Objective Population and Setting Intervention Results Comments

 Intervention: 25 (5.9%)

 Control: 38 (9%)

 P=0.08

·Intraoperative values

not statistically 

significant except for

Intraoperative values:

Hematocrit after CPB

 Interventions: 

27.07±4.20

 Control: 26.48±4.07

 P=0.05

·Postoperative values

Intra-aortic balloon pump

 Intervention: 5 (1.1%)

 Control: 14 (3.3%)

 P=0.03

Red cell transfusion 

patients

 Intervention: 261 

(62.3%)

 Control: 216 (51.5%)

 P=0.01

Procedures: Elective 

Coronary artery 

bypass grafting (CABG) 

or valve operations or 

both

Indications: NR

Setting: 1 tertiary-level 

hospital

Location: Spain

Dates: September 2003 –

January 2007

Inclusion Criteria: Adult 

patients (>18 years of 

Administered 2g of cefazolin 

intravenously between 

20-30 minutes after the 

induction of anesthesia, 

followed by 1g every 8 

hours. For all procedures 

lasting more than 3 hours, 

a new dose of 1g of 

cefazolin was 

administered

intraoperatively.

Standard preventive 

measures: NR

 Control: 8 (1.9%)

 P=0.19

 Osteomyelitis

 Intervention: 3 (0.7%)

 Control: 2 (0.5%)

 P=0.5

 Mediastinitis

 Intervention: 8 (1.9%)

 Control: 5 (1.2%)

 P=0.28

 Endocarditis

 Intervention: 5 (1.2%)

 Control: 1 (0.2%)

 P=0.10

Other infections: 

Sepsis

 Intervention: 17 (4.0%)

 Control: 18 (4.2%)

 P=0.50

Topic-specific outcomes:

Antimicrobial resistance: 

Pathogens isolated were 

similar distribution in 

both groups (P≥0.05). 

43/50 (86%) of SSIs were 

gram positive cocci (S. 

epidermis (SE) most 

common, followed by S. 

aureus (SA). 

SE-MRSE

 Intervention: 12/20 SE and 

12/35 (34.3%) SSI 

 Control: 5/9 SE and 5/15 

(33%) SSI

SE-MSSE

 Intervention: 8/20 SE and 

Infection involves 

the deep soft 

tissues of the 

incision with at 

least 1 of the 

following: 

purulent drainage, 

a deep incision 

that 

spontaneously 

dehisced or was 

deliberately 

opened by the 

surgeon when 

patient had a 

fever (temp 

≥38oC), or 

localized pain or 

tenderness 

(unless the results 

of an incisional 

culture were 

negative), or 

evidence of deep 

incision infection 

found in a direct 

examination or 

second operation

Mediastinitis –

Organ-space SSI 

characterized by 1 

of the following: 

positive results of 

a culture obtained 

from mediastinal 

tissue or fluid 
Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminated by the Centers for Disease Control and Prevention 

and should not be construed to represent any agency determination or policy. 34

Author

Year

(Data 

Extractor)

Study 

Design

Quality 

Score

Study Objective Population and Setting Intervention Results Comments

age) undergoing 

elective coronary 

artery bypass grafting 

(CABG), valve 

operations or both by 

means of sternotomy.

Exclusion Criteria: 

Presence of active 

infection, the 

administration of 

antimicrobial therapy 

in the 48 hours before 

surgical intervention, 

emergency surgical 

intervention, or allergy 

to betalactams. Also, 

patients with 

transplants or who did 

not wish to participate 

in the study.

8/35 (22.8%) SSI

 Control: 4/9 se and 4/15 

(26.6%) SSI

SA-MRSA

 Intervention : 4/11 SA and 

4/35 (11.4)% SSI 

 Control: 1/5 SA and 1/15 SSI 

(6.6%)

SA-MSSA:

 Intervention 7/11 SA and 

7/35 (20.0%) SSI

 Control: 4/5 SA and 4/15 

(26.6%) SSI

Gram negative bacilli in 

12/50 (24%) ; 

polymicrobial SSI rates 

similar between groups

Reoperations: NR

Length of stay:

Preoperative hospitalization 

d, (mean±SD)

 Intervention: 9.7±7.9

 Control: 10.8±10.3

 P=0.11

Mean ICU Stay d, (mean±SD)

Intervention: 10.3±10.9

 Control: 9.1±8.7

 P=0.09

Duration of hospitalization 

after operation d, 

(mean±SD)

Intervention: 14.75±15.8

 Control: 12.2±14.2

 P=0.25

during a surgical 

operation, patient 

fever (temp 

≥38oC), sternal 

pain or instability, 

mediastinal 

involvement 

suggested by a 

computed 

tomographic scan, 

or organisms 

cultured form the 

mediastinal area

Sternal osteomyelitis

– An organ-space 

SSI indicated by 

persistent 

purulent drainage 

from the 

sternotomy & 

confirmed by 

microbiologic and 

histopathologic 

findings.

Endocarditis – Organspace SSI 

characterized by 

Duke’s criteria 

(Durack 1994)

Perioperative care:

NR

Other notes: 

SSI Risk Stratification: 

NNIS

Statistical Analysis:

Study powered to 
Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminated by the Centers for Disease Control and Prevention 

and should not be construed to represent any agency determination or policy. 35

Author

Year

(Data 

Extractor)

Study 

Design

Quality 

Score

Study Objective Population and Setting Intervention Results Comments

Mortality:

30 day [n (%)]

Intervention: 22 (5.2%)

 Control: 31 (7.4%)

 P=0.12

90 day [n (%)]

Intervention: 29 (6.9%)

 Control: 37 (8.8%)

 P=0.18

365 day [n (%)]

Intervention: 43 (10.3%)

 Control: 48 (11.5%)

 P=0.34

Adverse events: [n (%)]

Intra-aortic balloon pump

 Intervention: 5 (1.1%)

 Control: 14 (3.3%)

 P=0.03

Red cell transfusion patients

 Intervention: 261 (62.3%)

 Control: 216 (51.5%)

 P=0.01

Arterial Fibrillation

 Intervention: 17 (4.0%)

 Control: 21 (5.0%)

 P=0.30

Respiratory Failure

 Intervention: 28 (6.6%)

 Control: 23 (5.4%)

 P=0.28

Acute Renal Failure

 Intervention: 21 (5.0%)

 Control: 27 (6.4%)

 P=0.22

detect reduction 

in SSI rate of <5% 

with a=0.20 and 

β=0.05 (n=419 in 

each arm)

Follow-up: Patients 

were examined 

daily while in the 

hospital. Cardiac 

surgeons 

personally 

followed up with 

patients in the 

cardiac outpatient 

clinic for at least 1 

year after 

discharge from 

the hospital
Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminated by the Centers for Disease Control and Prevention 

and should not be construed to represent any agency determination or policy. 36

Author

Year

(Data 

Extractor)

Study 

Design

Quality 

Score

Study Objective Population and Setting Intervention Results Comments

Renal replacement 

treatment

 Intervention: 12 (2.8%)

 Control: 13 (3.1%)

 P=0.50

Liu 

200831

(ES)

RCT

1, 2, 3, 

4, 6, 7, 

8, 10

To investigate 

the impact of 

the duration of 

prophylactic 

antimicrobials 

on postoperative 

wound 

infection in 

patients 

undergoing 

major head and 

neck neoplasm 

operations and 

to determine 

associated 

factors in postoperative 

wound 

infection.

Number of patients: 

n=53

Patient Characteristics: 

There were no 

significant differences 

between groups 

according to basic data 

and laboratory 

studies.

·Age y (mean±SD)

 Intervention:56.4±12.3

 Control: 56.5±11.1

·Gender (m/f)

 Intervention: 23/4

 Control:21/5

·Obesity: Average BMI

 Intervention: 23.6 

kg/m2

 Control: 23.6 kg/m2

·Comorbidities

Previous radiotherapy:

 Intervention: 2/27 

(14.8%)

 Control: 8/26 (30.8%)

Perioperative data:

Intervention group: n=27

Received one dose of 

preoperative prophylactic 

antimicrobial

(intravascular clindamycin 

300mg) one hour before 

incision and then at 6 

hour intervals over a 

period of 72 hours.

Timing of intervention: Pre 

and postoperatively

Duration of intervention: 1 

hour before incision to 24 

or 72 hours after surgery

Device/agent: clindamycin

Monitoring intervention: NR

Control group: n=26

Received one dose of 

preoperative prophylactic 

antimicrobial

(intravascular clindamycin 

300mg) one hour before 

incision and then at 6 

hour intervals over a 

period of 24 hours.

SSI: (follow up 30 days)

Surgical wound infection: n 

(%)

 Total: 13 (24.5%)

 Intervention: 5 (18.5%)

 Control: 8 (30.7%)

 P=0.473

Bivariate analysis of 

population based on 

infections

Bivariate analysis of 

population based on 

infections

Infected n=14 / Uninfected 

n=40

Tumor size (cm) (mean±SD)

 Infected: 3.2±1.3

 Uninfected: 2.2±1.1

 P=0.005

Tracheostomy

 Infected: 13 (100%)

 Uninfected: 14 (50%)

 P<0.001

Duration of antimicrobials

24 hours (Control)

 Infected: 8 (61.5%)

Definitions: 

Surgical wound 

infection: 

Purulent 

discharge either 

spontaneously or 

by incision and 

drainage within 

30 days after the 

operation.

Perioperative care: 

NR

Other notes: 

Operative 

procedures were 

all performed by 

one surgeon and 

all post-operative 

wound conditions 

were evaluated by 

another doctor 

(Statistical 

analysis: sample 

size not large 

enough and 

statistic power 
Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminated by the Centers for Disease Control and Prevention 

and should not be construed to represent any agency determination or policy. 37

Author

Year

(Data 

Extractor)

Study 

Design

Quality 

Score

Study Objective Population and Setting Intervention Results Comments

Surgical reconstruction

 Intervention: 4/27 

(14.8%)

 Control: 10/26 (38.5%)

Perioperative blood loss

 Intervention: 239±110

 Control: 262±136

Perioperative blood 

transfusion: YES

 Intervention: 4/27 

(14.8%)

 Control: 7/26 (26.9%)

Procedures: Head and 

neck surgical 

procedures

 Reconstruction with free 

flaps or pectoralis 

major myocutaneous 

flaps: 14/53 (26.4%)

 Intervention: 4 (14.8%)

 Control: 10 (38.5%)

Laryngectomies 

accounted for small 

portion of cases

Indications: 

Tumor Sites

Oral cavity/Oropharynx/ 

Larynx/ Hypopharynx/ 

Others

 Intervention: 18/2/1/2/4

 Control: 

1/7/2/13/3

Setting: 1 Veterans 

Hospital

Location: Taiwan

Standard preventive 

measures: NR

 Uninfected: 18 (45%)

 P<0.001

72 hours (Intervention)

 Infected: 5 (38.5%)

 Uninfected: 22 (55%)

 P<0.001

Previous radiotherapy

 Infected: 8 (61.5%)

 Uninfected: 4 (10.0%)

 P<0.001

Previous chemotherapy

 Infected: 9 (69.2%)

 Uninfected: 4 (10.0%)

 P<0.001

Surgical reconstruction

 Infected: 10 (76.9%)

 Uninfected: 4 (10%)

 P<0.001

Serum Albumin (g/dl±SD)

 Infected: 3.5±0.7

 Uninfected: 4.1±0.4

 P=0.013

Hemoglobin (g/dl±SD)

 Infected: 10.8±1.9

 Uninfected: 13.4±1.8

 P<0.001

Perioperative blood loss 

(ml±SD)

 Infected: 380±113

 Uninfected: 208 ±93

 P<0.001

Perioperative blood 

transfusion

 Infected: 7 (53.8%)

 Uninfected: 4 (10.0%)

 P<0.001

unsatisfied

Follow-up: 30 days 

postoperatively
Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminated by the Centers for Disease Control and Prevention 

and should not be construed to represent any agency determination or policy. 38

Author

Year

(Data 

Extractor)

Study 

Design

Quality 

Score

Study Objective Population and Setting Intervention Results Comments

Dates: January 2004-

December 2004

Inclusion Criteria: 

Patients scheduled to 

receive head and neck 

surgical procedures 

that would enter the 

upper aerodigestive 

tract.

Exclusion Criteria: Those 

under antimicrobial 

treatment, allergic to 

clindamycin, with 

diabetes mellitus, or 

reluctant to join this 

protocol.

Logistic regression identified 

preop hemoglobin ≤10.5g/dL 

(p=0.025) and surgical 

reconstruction (P=0.036) as 

independent risk factors

Other infections: NR

Topic-specific outcomes:

Antimicrobial Resistance: NR

13/53 (24.5%) total SSIs

6/13 (46.1%) polymicrobial

P. aeruginosa (9/13, 69.2%) 

E. faecalis (4/13, 30.0%)

K. pneumonia (4/13, 30.8%)

C. koseri (1/13, 7.7%)

A. baumannii (1/13, 7.7%)

Reoperations: NR

Length of stay: (days)

 Intervention: 22±15

 Control: 25±18

 P=0.627

Mortality: NR

Adverse events: One patient 

developed an allergic 

reaction after treatment 

and was forced to drop 

out.
Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminated by the Centers for Disease Control and Prevention 

and should not be construed to represent any agency determination or policy. 39

Author

Year

(Data 

Extractor)

Study 

Design

Quality 

Score

Study Objective Population and Setting Intervention Results Comments

Fujita

200710

(ES)

RCT

1, 2, 7, 

8, 9, 10

To determine 

the efficacy of a 

single-dose 

regimen of 

secondgeneration 

cephalosporin 

cefmetazole 

without 

metronidazole 

and oral 

antimicrobials 

with regards to 

reduction in 

incidences of 

surgical site 

infections and 

all other 

infectious 

complications 

following 

elective 

colorectal 

surgery.

Number of patients: 

N=377

Patient Characteristics: 

Although patient age 

was significantly 

higher in the control 

group, other patient 

characteristics were 

identical.

·Age y (mean±SD)

 Intervention: 59.4±11.1

 Control: 62.1±9.8

 P=0.01

·Gender (m/f)

 Intervention: 126/64

 Control: 107/80

·Obesity: NR

·Comorbidities: NR

Procedures: Colorectal 

Surgery

Conventional: n (%)

 Intervention: 129 

(67.9%)

 Control: 133 (71.1%)

 Colectomy/ anterior 

resection/ 

abdominoperineal 

resection

 Intervention: 73/56/0

 Control: 77/53/3

Laparoscopic: n (%)

 Intervention: 61 (32.1%)

 Control: 54 (28.9%)

 Colectomy/ Anterior 

resection

 Intervention: 49/12

Intervention group: n=190

Single Dose Group

Received 1 g cefmetazole 

just before skin incision. 

Though additional doses 

are recommended every 

3-4 hours during 

extended surgery, none 

were given

Timing of intervention: 

Preoperatively

Duration of intervention: 

Preoperatively or 

preoperatively and up to 

16 hours postoperatively 

in controls.

Device/agent: cefmetazole 

1g

Monitoring intervention: NA

Control group: n=187

3-Dose Group

Received 1 g cefmetazole 

just before skin incision 

plus 2 postoperative 1g 

doses at 8 and 16 hours 

after the first 

administration. Though 

additional doses are 

recommended every 3-4 

hours during extended 

surgery, none were given

Standard preventive 

measures:

Bowel Prep: Patients 

underwent mechanical 

SSI: (follow up NR)

Total SSI

 Intervention: 32/190 

(16.8%)

 Control: 17/187 (9.1%)

Incisional SSI n (%)

 Intervention: 27/190 

(14.2%)

 Control: 8/187 (4.3%)

 P=0.009

Organ or Space SSI n (%)

 Intervention: 5 (2.6%)

 Control: 9 (4.8%)

 P=0.26

Because only incidence of 

incisional SSIs differed 

significantly between groups, 

subset analysis performed: 

Multivariate analysis 

revealed antimicrobial dose 

was the only significant 

factor associated with 

incisional SSI (P=0.002). This 

result is confusing unless 

they meant to say 

antimicrobial duration.

The incidence of incisional 

SSI in the control was lower 

even in patients whose 

surgery lasted 3hrs or less 

than in the intervention 

group.

Definitions: ND

Perioperative care: 

To ensure that the 

trial results were 

applicable 

generally, specific 

instructions on 

surgical 

techniques and on 

postoperative 

care were not 

included

Other notes: 

Trial was designed as 

non-inferiority 

test to detect 5% 

difference in 

incidence of 

incisional SSI with 

CI 95%, power 

90% assuming 

incidence of 

infection of 5%. 

Sample size of 238 

required in both 

arm. After 1yr 

interim analysis 

revealed 

significant 

difference 

between groups 

and enrollment 

was stopped. 

Significance at 

<0.05

Follow-up: Wounds 
Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminated by the Centers for Disease Control and Prevention 

and should not be construed to represent any agency determination or policy. 40

Author

Year

(Data 

Extractor)

Study 

Design

Quality 

Score

Study Objective Population and Setting Intervention Results Comments

 Control: 42/12

No gastric or hepatic 

resections included)

Indications:

Colon cancer: 241 (63.9%)

Rectal cancer: 136 

(36.1%)

Setting: 7 major hospitals

Location: Japan

Dates: May 6, 2004 –

April 25, 2005

Inclusion Criteria: 

Patients aged 20-80 

years scheduled to 

undergo elective 

colorectal surgery.

Exclusion Criteria: 

Emergency 

operations, 

obstruction of the 

small bowel, stomal 

surgery or bypass 

surgery, preoperative 

infectious diseases, 

penicillin or 

cephalosporin allergy, 

antimicrobial 

administration before 

hospitalization, 

inflammatory bowel 

diseases, angina or 

myocardial infarction, 

mild or severe renal 

dysfunction, mild or 

severe diabetes 

mellitus, and steroid 

bowel prep with 2L 

polyethylene glycolelectrolyte solution 1 day 

before surgery. No oral 

AMP was administered as 

part of the bowel prep

The incidence of incisional 

SSI associated with 

laparoscopic surgery was 

lower than in conventional 

although not statistically 

significant

Other infections: Urinary 

tract infections, 

pneumonia, septicemia, 

infective diarrhea and line 

sepsis.

Other n (%)

 Intervention: 12 (6.3%)

 Control: 9 (4.8%)

 P=0.52

Total Infections: (SSI plus 

other) n (%)

 Intervention: 44 (23.1%)

 Control: 26 (13.9%)

 P=0.03

C. difficile Colitis: n (%)

 Intervention: 0

 Control: 2 (1.1%)

Topic-specific outcomes: NR

Reoperations: NR

Length of stay: days 

(mean±SD)

 Intervention: 12.5±7.4

 Control: 12.2±5.6

 P=0.66

 With incisional SSI: n=35

 14.6±9.3

 Without incisional SSI: 

n=342

 12.1±6.2

were checked 

daily until 

discharge and at 

the first 

postoperative 

hospital visit 

(when? NR)
Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminated by the Centers for Disease Control and Prevention 

and should not be construed to represent any agency determination or policy. 41

Author

Year

(Data 

Extractor)

Study 

Design

Quality 

Score

Study Objective Population and Setting Intervention Results Comments

administration before 

surgery

 P=0.03

Mortality: NR

Adverse events:

Postoperative Complications 

[Mainly Small Bowel 

Obstruction] n(%)

 Intervention: 18 (9.5%)

 Control: 18 (9.6%)

 P= 0.96

Mohri 

200743

(ES)

RCT

1, 4, 6, 

7, 8, 9, 

To compare the 

efficacy of 

single- and 

multiple-dose 

antimicrobial 

prophylaxis for 

the prevention 

of surgical-site 

infection in 

patients 

undergoing 

elective gastric 

cancer surgery.

Number of patients: N= 

486

Patient Characteristics: 

Baseline 

characteristics were 

similar between 

groups.

·Age mean (range) years

 Intervention: 68 (22-91)

 Control: 68 (23-90)

·Gender: no male (%)

 Intervention: 174 

(71.6%)

 Control: 164 (67.5%)

·Obesity Mean BMI 

(range)

 Intervention: 21.6kg/m2 

(13.4-31.6)

 Control: 21.4kg/m2 

(13.6-34.0)

·Comorbidities

Diabetes Mellitus (no (%))

 Intervention: 17 (7.0%)

 Control: 19 (7.8%)

Gastric Cancer: T1/ T2-4

 Intervention: 94/149

Intervention group: n=243

Single does prophylaxis

Cefazolin 1 g IV: n=122

(50.2%)

Ampicillin-Sulbactam 1.5g: 

n=121 (49.8%)

30 minutes prior to surgery, 

patients received either

1g cefazolin or 1.5 g 

ampicillin-sulbactam by 

slow intravenous infusion 

over 15 minutes. An 

additional dose was 

administered if the 

operation was prolonged 

beyond 3h.

Timing of intervention:

Preop and intraop if 

procedure lasted >3hrs 

Duration of intervention:

Preop and intraop if 

procedure lasted >3hrs 

vs. perioperative in 

controls for total 7 AMP 

doses ( at 12 hr intervals )

Device/agent: cefazolin 1g IV 

SSI: (follow up 6 weeks)

Overall n (%): 44 (9.1%)

 Intervention: 23 (9.5%)

 Control: 21 (8.6%)

 Difference %: 0.9 (-4.3, 5.9)

3 patients in the intervention 

group had an infection 

that involved both the 

incisional and deep/organ 

space sites

Incisional (n (%))

 Intervention: 14 (5.8%)

 Control: 11 (4.5%)

 Difference %: 1.3 (-2.7, 5.2)

Organ/Space

 Intervention: 12 (4.9%)

 Control: 10 (4.1%)

 Difference %: 0.8 (-2.9, 4.5)

Other infections: NR

Topic-specific outcomes:

Antimicrobial Resistance:

33/47 (70.2%) SSIs had 

purulent discharge and 

were cultured.

13/33 (39.3%) were culture 

positive

Definitions: CDC:

Incisional SSI: 

Infection 

occurring within 

30 days after 

operation and 

involving skin, 

subcutaneous 

tissue or deep soft 

tissue (e.g. fascial 

and muscle layers) 

of the incision 

site, and at least 

one of the 

following

 Purulent drainage, 

with or without 

laboratory 

confirmation, from 

the incision

 Organisms isolated 

from an aseptically 

obtained culture of 

fluid or soft tissue 

from the incision

 At least one of the 
Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminated by the Centers for Disease Control and Prevention 

and should not be construed to represent any agency determination or policy. 42

Author

Year

(Data 

Extractor)

Study 

Design

Quality 

Score

Study Objective Population and Setting Intervention Results Comments

 Control: 108/135

Operative details:

Blood loss: mean (range)

Intervention: 338 (10-

2811)

Control:405.7 (10-2917)

P=0.028

Extent of Lymph node 

resection 

D0 or D1

Intervention: 92/243

Control:112/243

D2

Intervention 151/243

Control: 131/243

Procedures: Elective 

gastric cancer surgery

Total or proximal 

gastrectomy/ distal 

gastrectomy/ wedge 

resection/ 

gastrojejunostomy

 Intervention: 

78/147/2/16

 Control: 94/141/1/7

Indications: gastric 

cancer

Setting: 10 centers

Location: Japan

Dates: May 2001 –

December 2004

Inclusion Criteria: 

Patients undergoing 

or ampicillin-sulbactam 

1.5g (V

Monitoring intervention:

Control group: n=243

Multiple dose prophylaxis

Cefazolin: n=121 (49.8%)

Ampicillin-sulbactam: 

n=122(50.2%)

30 minutes prior to surgery, 

patients received either 

1g cefazolin or 1.5 g 

ampicillin-sulbactam by 

slow intravenous infusion 

over 15 minutes. An 

additional dose was 

administered if the 

operation was prolonged 

beyond 3h. The same 

dose of antibiotics was 

given at 12 hour intervals 

postoperatively to 

achieve a total of 7 

antibiotic doses.

Standard preventive 

measures:

Hair removal: Hair was 

“shaved” using electric 

clippers after induction of 

general anesthesia

Skin prep: surgical site was 

wiped with 10% 

povidone-iodine solution 

before surgery and 

draped with a disposable 

towel.

Closure: Absorbable 

S. aureus: 3 Intervention; 2 

control

 MRSA: 2 intervention 2 

control

E. faecium 1 control

Streptococcus spp. 1 control

E. coli 1 intervention

S. marcescens 1 intervention

Enterobacter spp 1 

intervention

There were no appreciable 

differences between 

groups in the resistance 

pattern of isolates.

Reoperations: NR

Length of stay: NR

Mortality: NR

Adverse events: AMP was 

not associated with any 

major side effects

following signs or 

symptoms of 

infection: pain or 

tenderness, 

localized swelling, 

redness, heat or 

fever (38oC)

 Spontaneous 

wound dehiscence

 Abscess or other 

evidence of 

infection involving 

the fascia or muscle 

layer found on 

direct examination, 

during reoperation, 

or by 

histopathological or 

radiological 

examination.

Organ/space SSI: 

Infection occurring 

within 30 days after 

operation and 

involving the intraabdominal cavity 

and at least one of 

the following:

 Purulent discharge 

from a drain placed 

through a stab 

wound into the 

intra-abdominal 

cavity

 Organisms isolated 
Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminated by the Centers for Disease Control and Prevention 

and should not be construed to represent any agency determination or policy. 43

Author

Year

(Data 

Extractor)

Study 

Design

Quality 

Score

Study Objective Population and Setting Intervention Results Comments

elective gastric cancer 

surgery in one of ten 

centers.

Exclusion Criteria: 

Aged<20 years, 

pregnant, allergic to 

penicillins or 

cephalosporins, had 

received antimicrobial 

treatment in the past 

2 weeks, had an 

infection at the time 

of surgery, had 

malignant disease of 

another organ, or had 

colorectal resection at 

the time of surgery. 

Also, moderate or 

severe liver disease 

(alkaline phosphatase, 

alanine 

aminotransferase, 

aspartate 

aminotransferase or 

total bilirubin more 

than 5 times the upper 

limit of normal) and 

sever renal 

impairment (serum 

creatinine level above 

2.0 mg/dl.)

synthetic sutures were 

used for closure of the 

fascia and peritoneum. 

Skin was closed using 

stainless steel staples and 

the wound then wiped 

with normal saline. 

Staples were removed 

after 7 days.

Drains: Intra-abdominal 

drainage tubes were 

passed through a stab 

incision separate from the 

wound. They were 

removed within 48h of 

surgery

Local antimicrobial Irrigation: 

None

Adhesive dressing: site kept 

covered with an adhesive 

dressing until removal of 

the staples.

Non-standard preventive 

measures:

Antimicrobial prophylaxis

choice: choice of cefazolin or 

ampicillin-sulbactam was left 

to the operating surgeon 

who was blinded to 

treatment schedule.

form an aseptically 

obtained culture of 

fluid or tissue in the 

intra-abdominal 

cavity

 Abscess or other 

evidence of 

infection involving 

the intra-abdominal 

cavity found on 

direct examination, 

during reoperation, 

or by 

histopathological or 

radiographic 

examination.

Perioperative care: 

See standard 

preventive 

measures

Other notes: None

Follow-up: Patients 

assessed daily 

until discharge 

with 

postoperative 

follow-up at 6 

weeks by an 

independent 

investigator at 

each institution.
Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminated by the Centers for Disease Control and Prevention 

and should not be construed to represent any agency determination or policy. 44

Author

Year

(Data 

Extractor)

Study 

Design

Quality 

Score

Study Objective Population and Setting Intervention Results Comments

Togo

200744

(ES)

RCT

1, 2, 6, 

7, 8, 9, 

10

To investigate 

two different 

postoperative 

durations of 

antimicrobial 

prophylaxis 

administration 

(fluorometholo

ne) after 

elective 

hepatectomy 

and their 

respective 

impact on the 

incidence of SSI 

and Systemic 

inflammatory 

response 

syndrome 

(SIRS). 

Specifically, 2-

day versus 5-

day 

postoperative 

regimens.

Number of patients: 

N=180

Patient Characteristics: 

There were no 

significant differences 

in any category 

between groups.

·Age y (mean ±SD)

 Intervention: 62.8±11.2

 Control: 61.6±10.7

·Gender (m/f)

 Intervention: 55/34

 Control: 61/30

·Obesity-NR

·Comorbidities

Diabetes Mellitus (-/±/+)

 Intervention: 70/5/14

 Control: 68/5/18

Operative findings:

No significant difference 

between groups in terms 

of resection rates, 

number of liver segments 

resected, prognostic 

score, operation time, 

blood loss or blood 

transfusion

Procedures: Elective 

Hepatectomy without 

the reconstruction of 

the biliary or intestinal 

tract

Indications: 

Hepatocellular 

carcinoma/ liver 

metastasis/ donor/ other

Intervention group: n= 89

1g fluorometholone was 

administered 30 minutes 

before surgery, followed 

by 1g every 3 hours 

during surgery, 1g 2 hours 

after completion of 

surgery, and then 1g 

every 12 hours)for 2 days 

postoperatively

Timing of intervention: Pre-, 

intra-, and 

postoperatively

Duration of intervention: 

Beginning 30 minutes 

before surgery and 

continued for 2 days vs. 5 

days in controls 

Device/agent: 

fluorometholone 1g IV

Monitoring intervention:

Hematological and 

biochemical tests were 

performed before 

surgery, immediately 

after surgery, and 

additional tests were 

performed as needed.

Control group: n=91

1g fluorometholone was 

administered 30 minutes 

before surgery, followed 

by 1g every 3 hours 

during surgery, 1g 2 hours 

after completion of 

surgery, and then 1g 

SSI: (follow up 30 days)

Total SSI

 Intervention: 4 (4.5%)

 Control: 4 (4.4%)

 P=0.033

 Intra-abdominal infection

(infection at cut surface of 

liver= Organ/Space)

 Intervention: 2 (2.2%)

 Control: 3 (3.3%)

 Wound infection

(Incisional)

 Intervention: 2 (2.2%)

 Control: 1 (1.1%)

 Statistically Significant 

Postoperative infection 

Risk Factors

 Infected n=13

 Non-infected: n=167

Duration of operation 

(mean±SD)

 Infected: 494±106 min

 Non-infected: 352±107 min

 P<0.001

Bile Fistula (+/-)

 Infected: 4/9

 Non-infected: 4/163

 P<0.001

Other infections:

Remote Infections

 Intervention: 3 (3.4%)

 Control: 2 (2.2%)

 P=0.242

 Catheter Infection

 Intervention: 2 (2.2%)

Definitions: 

SSI: CDC Guideline 

definitions for 

Prevention of 

Surgical Site 

Infection were 

used.

Inflammatory 

findings (fever 

and flare, 

drainage of pus 

from incision, or 

drain, detection of 

a pathogen by 

culture of fluid or 

tissue sample and 

fluid retention on 

imaging indicating 

presence of pus in 

a deep region. 

Cases judges as 

SSI by physician 

included even if 

pus drainage and 

culture negative. 

Systemic 

Inflammatory 

Response 

Syndrome (SIRS): 

the consensus 

criteria 

established by the 

American Thoracic 

Society and the 

Society of Critical 

Care Medicine 
Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminated by the Centers for Disease Control and Prevention 

and should not be construed to represent any agency determination or policy. 45

Author

Year

(Data 

Extractor)

Study 

Design

Quality 

Score

Study Objective Population and Setting Intervention Results Comments

 Intervention: 33/43/4/9

 Control: 33/45/5/8

Setting: 1 University 

Hospital

Location: Japan

Dates: April 2003 –

March 2006

Inclusion Criteria: 

Patients who 

underwent elective 

liver resection for 

hepatic lesions.

Exclusion Criteria:

Patients who were 

concomitantly treated 

with the resection of 

other organs –

resection and 

anastomosis of the 

bile duct; drainage and 

resection and 

anastomosis of the 

digestive tract and 

patients In whom 

apparent infection was 

noted at the time of 

surgery. Also, patients 

with a past medical 

history of allergic 

reaction to β-lactams, 

a pre-operative serum 

creatinine level of ≥1.5 

mg/dL, diabetes 

mellitus under insulin 

control, treatment 

with antimicrobials 

every 12 hours for 5 days 

postoperatively

Standard preventive 

measures:

ABX prophylaxis: No patient 

received pre-operative 

administration of oral 

antimicrobial agents.

 Control: 2 (2.2%)

 Pneumonia

 Intervention: 1 (1.1%)

 Control: 0

Postoperative infections 

total (SSI + RI)

 Intervention: 7 (7.9%)

 Control: 6 (6.6%)

 P=0.049

SIRS Positive Rate

At Postop day 2

 Intervention: 26 (31.7%)

 Control: 12 (14.1%)

 P=0.007

At Postop day 3

 Intervention: 12 (14.6%)

 Control: 4 (4.7%)

 P=0.029

After Postop day 3

 Intervention: 6 (7.3%)

 Control: 5 (5.9%)

 P=0.709

SIRS Duration all (mean)

 Intervention: 1.34 days

 Control: 0.95 days 

 P=0.065

Topic-specific outcomes:

Treatment: when postoperative infection was 

diagnosed during the 

study, the treatment was 

changed to therapeutic 

antimicrobial agents.

Diarrhea:

 Intervention: 2/ 89 (2.2%)

were used. When 

2/ 4 of the 

following criteria 

were present:

 Body temperature 

of ≤ 36oC and ≥38oC

 A pulse rate of 

≥90/min

 A respiratory rate 

of ≥ 20/min or 

PaCO2> 32 torr

 White blood cell 

counts of 

≥12,000/mm3and 

≤4,000/mm3or 

≥10% immature 

cells

Biliary 

Complications: 

 Drainage of bile 

from the abdominal 

wound and drain, 

showing a total 

bilirubin level of 

>5mg/mL or 3 times 

the serum level in 

the discharge fluid.

 An intraabdominal 

accumulation of bile 

confirmed by 

percutaneous 

drainage

 Cholangiographic

evidence of bile 
Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminated by the Centers for Disease Control and Prevention 

and should not be construed to represent any agency determination or policy. 46

Author

Year

(Data 

Extractor)

Study 

Design

Quality 

Score

Study Objective Population and Setting Intervention Results Comments

within 1 week before 

surgery, judged 

ineligible by the 

attending physician, 

and non-consent to 

the study.

 Control: 0

P=0.150

 No cases of C. difficile

detected.

Reoperations: NR

Length of stay:

 Intervention: 15.24±6.84 

days

 Control: 15.11±6.07 days

 P=0.896

Mortality: None during the 

admission period in either 

group

Adverse events:

No severe complications 

were observed.

leakage.

Post-operative 

complications: 

conditions in which 

the admission 

period after surgery 

exceeded 22 das 

(mean±SD), 

Perioperative care: 

NR

 

Other notes: None

Follow-up: 30 days 

after surgery

Ali

200612

(ES)

RCT

4, 5

To compare the 

proportion of 

early 

postoperative 

infection cases 

in clean 

orthopedic 

surgery after a 

single dose of 

prophylactic 

antimicrobial 

and multiple 

doses of 

prophylactic 

antimicrobial

Number of patients: 

N=200

Patient Characteristics: 

NR

Procedures: mix of clean 

orthopedic fracture 

surgeries

Setting: 1 public hospital

Location: Pakistan

Dates: April 2004 –

March 2005

Inclusion Criteria: Any 

age and either gender 

undergoing clean 

orthopedic surgery 

and available for 

complete follow-up.

Intervention group: n=100

1dose: 1 dose of 2g 

ceftazidime intravenously 

30 minutes before the 

initial operative incision 

and 2 placebo doses after 

12h each.

Timing of intervention: pre 

and postop.

Duration of intervention: 

preop up to 24h postop.

Device/agent: ceftazidime.

Control group: n=100

3dose: 1 dose of 2g 

ceftazidime intravenously 

30 minutes before the 

initial operative incision 

SSI 

All SSI

1dose: 8/100

Multi: 6/100

Deep SSI

Total: 4 (2%) 

1 dose: 1% 

Multi: 3%; 

p=0.34

Superficial SSI

Total of 10 (5%) superficial 

SSIs and no difference:: 

1dose: 7% 

Multi: 3%; 

p=0.21

Definitions: 

Wound evaluation: 

done using the 

prescribed 

proforma for 

postoperative 

fever developing 

or persisting 

48hours after the 

surgery, discharge 

from the wound, 

and overlying skin 

inflammation. 

Wound infection was 

noted to be 

superficial or 

deep.
Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminated by the Centers for Disease Control and Prevention 

and should not be construed to represent any agency determination or policy. 47

Author

Year

(Data 

Extractor)

Study 

Design

Quality 

Score

Study Objective Population and Setting Intervention Results Comments

Exclusion Criteria: 

Patients with any 

generalized 

debilitating disease, 

diabetes mellitus, any 

infective focus in the 

body, poor quality of 

the skin at the incision 

site, allergy to 

cephalosporin, open 

fracture, revision 

surgery within last 6 

weeks, use of 

antimicrobials within 

the last 7 days and 

duration of surgery 

>3h.

and 2 doses after 12h 

each.

Standard preventive 

measures: 

Weight adjusted dosing: in 

patients under 12y, the 

antimicrobial prophylaxis 

dose was adjusted for 

weight.

Antimicrobial resistance: 

Staphylococcus aureus was 

the commonest organism 

isolated, followed by E.

coli. Eight of the 14 SSIs 

had a negative wound 

culture (7 superficial, 1 

deep). No mention of 

resistance

Other notes: None

Follow-up: 28 days

Mui

20056

(ES)

RCT

1, 6, 7, 

8, 9

To investigate 

the infective 

complications 

rate after open 

appendectomy 

for nonperforated 

appendicitis 

(NPA)receiving 

different 

durations of 

prophylactic 

antimicrobials 

cefuroxime and 

metronidazole

perioperative 

regimens: 

1) single dose 

preoperative, 

Number of patients: 

N=269

Patient Characteristics: 

All baseline 

characteristics were 

comparable

·Age: mean (SD), years

 Intervention1: 36.3 

(15.6)

 Intervention2: 32.1 

(13.2)

 Control: 35.1 (13.4)

 P=0.12

·Gender (m/f)

 Intervention1: 65/27

 Intervention2: 66/28

 Control: 54/29

 P=0.68

·Obesity

Intervention1 group: n= 92 

Intravenous cefuroxime 

(1.5g) and metronidazole 

(500mg) were given at 

induction of general 

anesthesia.

Intervention2 group: n= 94 

Intravenous cefuroxime 

(1.5g) and metronidazole 

(500mg) were given at 

induction of general 

anesthesia followed by 

two more doses of IV 

antimicrobials.

Timing of intervention: Pre 

operatively

Duration of intervention: 

Single dose at induction 

of anesthesia vs. up to 5 

SSI: (follow up 30 days)

Wound infections

 Intervention1: 6/92 (6.5%)

 Odds Ratio (95% CI): 1

 Intervention2: 6/94 (6.4%)

 Odds Ratio (95% CI): 1.01 

(0.34-3.26)

 Control: 3 (3.6%)

 Odds Ratio (95% CI): 0.89 

(0.46-7.79)

 P I1&I2=0.97

 P I1orI2 & C= 0.5

All required local wound 

exploration with daily 

dressing

All infected wounds were 

healed by 30-days 

postoperative follow up.

Definitions: 

Wound infection: 

discharge of pus 

that required 

surgical drainage 

before discharge

Intra-abdominal 

collection or 

abscess: a fluid 

collection 

diagnosed at 

ultrasound or 

computed 

tomography 

which required 

drainage

C. difficile

enterocolitisdiagnosed by 
Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminated by the Centers for Disease Control and Prevention 

and should not be construed to represent any agency determination or policy. 48

Author

Year

(Data 

Extractor)

Study 

Design

Quality 

Score

Study Objective Population and Setting Intervention Results Comments

2) 1 preop and 

2 postop 

(three-dose/1-

day) and 

3) preop and 5-

days postop

·Comorbidities

Procedures: Emergency 

open appendectomy

through right lower 

quadrant incision 

using muscle splitting 

approach and 

appendices were 

removed in the 

standard fashion

Indications: acute nonperforated 

appendicitis

Setting: 1 university 

hospital

Location: China

Dates: July 1995 –

December 2000

Inclusion Criteria: 

Patients aged 15-70 

with the clinical 

diagnosis of acute, 

non-perforated 

appendicitis 

undergoing 

emergency open 

appendectomy 

Exclusion Criteria: 

Patients who had a 

history of 

preadmission 

antimicrobials, 

diabetes mellitus, 

steroid therapy, 

known drug allergy to 

the study 

days postoperatively for 

controls

Device/agent: Intravenous 

cefuroxime 1.5g, and 

metronidazole 500mg.

Monitoring intervention: NR

Control group: n= 83

Intravenous cefuroxime 

(1.5g) and metronidazole 

(500mg) were given at 

induction of general 

anesthesia followed by a 

5-day course of 

antimicrobials. IV 

Antimicrobials were 

administered until 

patients could tolerate a 

semi-solid or solid diet 

when IV antimicrobials

were substituted by oral

formula: 250mg 

cefuroxime 2x/day and 

400mg metronidazole

3X/day

Standard preventive 

measures:

Closure: The peritoneum, 

oblique muscles and the 

Scarpa’s fascia were 

closed with 3/O 

polyglycolic sutures and 

the skin was closed with 

interrupted vertical 

mattress with 3/O 

monofilament sutures in a 

standardized manner.

Intra-abdominal 

Infections/abscesses

No patients developed intraabdominal collection or 

abscesses. 

Other infections: NR

Topic-specific outcomes: 

The incidence of AMPrelated complications was 

significantly higher in the 

control group (5d) as 

compared with 

Intervention 1 (single 

dose):

OR, (95% CI) 1.05(1.001-

1.1); P=0.048

C. difficile enterocolitis

 Intervention1 (single dose): 

0 

 Odds Ratio (95% CI): 1

 Intervention2 (3d): 1 (1.1%)

 Odds Ratio (95% CI): 1.01 

(0.99-1.03)

 Control (5d): 4 (4.8%)

 Odds Ratio I1 vs. C (95% 

CI): 1.05 (1.001-1.1)

 P I1&I2=1.0

 P I1 & C= 0.048 via Fisher’s 

exact test

All cases of C. diff 

enterocolitis recovered

uneventfully after 7d 

course of oral vancomycin

Reoperations: 

By definition (see next 

column) all wound 

positive fecal

clostridium toxin

Perioperative care:

Discharge: when fully 

mobilized, could 

tolerate a normal 

oral diet with 

evidence of bowel 

activity (normal 

bowel sounds and 

passing flatus or 

stool), apyrexial 

for 12h (<37oC 

tympanic), and 

had adequate 

pain control on 

oral analgesics.

Other notes: Study is 

underpowered

Patients were 

randomized after 

open

appendectomy 

determined NPA

Follow-up: After 

discharge all 

patients were 

followed up at 10 

days 

postoperatively 

for wound 

assessment and 

stitches removal 

and the second 

follow up was 

conducted for 
Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminated by the Centers for Disease Control and Prevention 

and should not be construed to represent any agency determination or policy. 49

Author

Year

(Data 

Extractor)

Study 

Design

Quality 

Score

Study Objective Population and Setting Intervention Results Comments

antimicrobials, 

ruptured appendicitis 

and appendicular mass 

or abscess formation. 

Also, pregnant women 

and patients who 

refused consent.

 Peritoneal lavage: none

 Wound Lavage: none

 Local antimicrobials: none

infections (15/15) 

required surgical drainage

All infections were treated 

by laying open the wound 

site, and packing with 

normal saline ribbon 

gauze twice per day to 

allow healing by 

secondary intention.

All infected wounds were 

healed at 30d f/u

Length of stay: mean (SD) 

days

 Intervention1: 4.3 (1.3)

 Intervention2: 4.6 (1.2)

 Control: 4.8 (2.3)

 P=0.13

Mortality: No perioperative 

mortality

Adverse events: See topic 

specific events for AMP 

adverse events

wound problems 

occurring at 30 

days 

postoperatively

Chang 

200533

(ES)

RCT 

(pilot 

study)

1, 2, 9, 

10

To investigate 

whether a short 

course of 

antimicrobials 

(<24 hours 

between the 

first and final 

doses) is as 

efficacious as 

longer courses 

(30-60 hours) in 

laparoscopically 

assisted vaginal 

hysterectomy 

Number of patients: 

N=156

Patient Characteristics: 

No differences in 

patient or operative 

characteristics 

between groups.

·Age: years mean ±SD

 Intervention: 41.1±5.8

 Control: 42.3±7.1

·Gender: 100% Female

·Obesity: NR

·Comorbidities: NR

Intervention group: n=74

Intravenous push stat of 2g 

cephalothin followed by a 

1g injection every 6 

hours. Gentamycin began 

with an 80mg IV drip 

followed by a 60-80mg 

injection every 8 hours. 

The first dose was 

administered within 1 

hour prior to the incision 

and continued for <24 

hours

Timing of intervention: Pre 

SSI: (follow up within 7 days 

of discharge)

Operative Site Infection

 Intervention: 2/74 (2.7%)

 1/2: Trocar site wound 

infection 

 1/2: 1 cuff abscess 

 Control: 3/82 (3.6%)

 1/3: infection 

 1/3: cellulitis 

 1/3: trocar site wound 

infection during 

hospitalization (instead of 

within 7 days of 

Definitions: 

Operative site 

infection: includes 

pelvic cellulitis, 

vaginal cuff 

abscess, pelvic 

abscess, and 

wound infection 

(Sharpiro 1982)

Urinary tract 

infection (UTI): 

diagnosed from 

patients’ 

symptoms and 
Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminated by the Centers for Disease Control and Prevention 

and should not be construed to represent any agency determination or policy. 50

Author

Year

(Data 

Extractor)

Study 

Design

Quality 

Score

Study Objective Population and Setting Intervention Results Comments

(LAVH). Procedures: 

Laparoscopically 

assisted vaginal 

hysterectomy (LAVH)

Indications: 

Myoma uterus: 70

 Intervention: 37

Adenomyosis: 53

 Intervention: 28

Cervical carcinoma in situ: 

17

 Intervention:10

Cervical carcinoma Ia1: 9

 Intervention:3

Other: 7

Setting: 1 medical center

Location: Taiwan

Dates: June 2001-July 

2002

Inclusion Criteria: 

Patients undergoing 

LAVH. Preop serum 

hemoglobin 

level>9g/dL and 

normal renal function 

tests (serum 

BUN/Creatinine)

Exclusion Criteria: LAVH 

cases with 

complications and 

those patients who 

required therapeutic 

antimicrobials and 

other associated 

surgical procedures 

were excluded from 

and postoperatively

Duration of intervention: 

From 1 hour prior to 

incision to either <24 

hours or 30-60hours

Device/agent: Cephalothin 

2g IV and gentamycin

80mg IV

Monitoring intervention: NR

Control group: n=82

Intravenous push stat of 2g 

cephalothin followed by a 

1g every 6 hours. 

Gentamycin began with 

an 80mg IV drip followed 

by a 60-80mg injection 

every 8 hours. The first 

dose was injected within 

1 hour prior to the 

incision and continued for 

24 hours

Standard preventive 

measures:

NR

discharge)

 P=0.735

Other infections: Urinary 

Tract Infection:

 Intervention: 2 (2.7%)

 1/2: during 

hospitalization

 1/2: w/in 7 days of 

discharge

 Control: 2 (2.4%)

 2/2: w/in 7 days of 

discharge

 P=0.917

Topic-specific outcomes: NA

Reoperations: NR

Length of stay: days 

(mean±SD)

 Intervention: 4.3±1.1

 Control: 4.2±1.3

 P=0.89

Mortality: NR

Adverse events: NR

signs and to 

whether there 

was a positive 

urinalysis

Perioperative care: 

NR

Other notes: Pilot 

study with low 

power to 

determine 

statistically 

significant 

differences in the 

rate of operation 

site infection and 

UTI between the 2 

groups. To 

achieve power of 

0.80, 3,800-5,200 

cases in both 

groups would be 

necessary

Follow-up: Within 7 

days of discharge 

collected from 

patients’ charts
Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminated by the Centers for Disease Control and Prevention 

and should not be construed to represent any agency determination or policy. 51

Author

Year

(Data 

Extractor)

Study 

Design

Quality 

Score

Study Objective Population and Setting Intervention Results Comments

the study

Su

20058

(ES)

RCT

1, 2, 

To compare the 

efficacy of a 

single-dose 

versus a 1-day 

course of 

prophylactic 

antimicrobials 

for 

postoperative 

wound 

infection 

outcomes and 

costeffectiveness in 

gynecologic 

operations.

Number of patients: 

N=531 

Patient Characteristics: 

(N=548 before 17 

patients excluded due 

to loss to f/u) There 

were no differences 

between groups 

regarding general 

status

·Age year (Mean±SD)

 Intervention: 

45.77±9.74

 Control:45.18±9.31

·Gender: 100% Female

·Obesity: BMI kg/m2

(mean±SD)

 Intervention: 

23.21±1.13

 Control:23.32±1.05

·Comorbidities: NR

Wound classification:

Clean: LAOC

Clean contaminated: TVH, 

TAH, LAVH

Operative characteristics:

Intervention group: n= 267

One dose of 1g cefazolin 

intravenously before 

surgery upon induction of 

anesthesia by the 

anesthesiologist within 30 

minutes before surgery. 

If the surgery duration 

was greater than 4h, and 

additional dose of 1.g 

cefazolin was 

administered 

intravenously.

Timing of intervention: Pre, 

intra and postoperatively

Duration of intervention: 

Either preoperatively, or 

Preoperatively through 24 

hours postoperatively.

Device/agent: Cefazolin 1g 

IV

Monitoring intervention: NR

Control group: n= 264

One dose of 1g cefazolin 

intravenously before 

surgery upon induction of 

SSI: (follow up 90 days)

Serious infectious morbidity

 Intervention: 1/267 (0.37%)

 1/1: Trocar wound 

infection at postop day 27 

from LAOC surgery

 Control: 1/264 (0.37%)

 1/1: vaginal cuff infection 

with pelvic abscess at 

postop day 7 from LAVH 

surgery

Other infections:

Fever (>38.5oC on two 

occasions 4 or more hours 

apart excluding the night 

of surgery)

 Intervention: 112 

/267(41.9%)

 67/112 had blood drawn 

for cultures but none had 

septicemia

 Control: 120/264 (45.4%)

 74/112 had blood drawn 

for cultures but none had 

septicemia

Definitions: 

Infectious morbidity:

If body temperature 

was greater than 

38.5oC, the 

patient was 

assessed for signs 

and symptoms of 

infection including 

one or more of 

the following: 

 An abdominal 

wound infection or 

trocar wound 

infection (including 

wound discharge or 

abscess)

 Pelvic Abscess or 

tubo-ovarian 

abscess

 Vaginal cuff abscess

 Postoperative 

septicemia

Perioperative care: 

Anesthesia
Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminated by the Centers for Disease Control and Prevention 

and should not be construed to represent any agency determination or policy. 52

Author

Year

(Data 

Extractor)

Study 

Design

Quality 

Score

Study Objective Population and Setting Intervention Results Comments

Duration of surgery: 

(min) mean±SD

Intervention: 98.14±35.54

Control: 98.87±35.48

Procedures: Total vaginal 

hysterectomy (TVH)

Total abdominal 

hysterectomy (TAH)

Laparoscopic-assisted 

vaginal hysterectomy 

(LAVH)

Laparoscopic assisted 

ovarian cystectomy 

(LAOC)

LAOC/LAVH/TAH/TVH

 Intervention: 

36/190/27/20

 Control:34/195/25/21

Indications: NR

Setting: 1 hospital

Location: Taiwan

Dates: June 1, 2001 –

January 31, 2003

Inclusion Criteria: 

Women ≥18 years old 

scheduled to undergo 

elective vaginal or 

abdominal 

hysterectomy (total 

vaginal hysterectomy 

(TVH) and total 

abdominal 

hysterectomy (TAH), 

laparoscopic-assisted 

vaginal hysterectomy 

or ovarian cystectomy 

anesthesia by the 

anesthesiologist within 30 

minutes before surgery 

followed by another three 

doses of 1g cefazolin 

every 6hr after surgery X1 

day. If the surgery 

duration was greater than 

4h, and additional dose of 

1.g cefazolin was 

administered 

intravenously.

Standard preventive 

measures: There were no 

differences between 

groups regarding 

preoperative examination 

and preparation, skin 

disinfection, 

postoperative 

intravenous fluid therapy 

(for 36h only), and 

indwelling urethral 

catheterization (for 24h

only).

Skin Prep: The surgical site 

was prepared by 

swabbing with povidoneiodine or alcohol—iodine 

for about 5 min and 

Hair removal-trimming/ 

shaving of the surgical 

area according to the 

“standard practice” in our 

hospital (d not specify 

how many in each).

Topic-specific outcomes: 

Timing of AMP before 

incision (min) mean±SD

Intervention: 21.07±9.96

Control:22.70±13.22

Antimicrobial resistance: 

none reported. 

 Intervention trocar wound 

culture: P. aeruginosa

Control vaginal cuff cultures: 

E coli, B. fragilis

Reoperations:

Intervention: Infection 

required debridement of 

trocar wound and 

drainage with pen-rose 

drain. Readmission stay 

was 8 days

Control: Infection & abscess 

required drainage with 

pen-rose drain and 

readmission stay was 4 

days.

Length of stay: days, 

(mean±SD)

 Intervention: 3.97±1.27

 Control:4.02±1.51

Mortality: NR

Adverse events: NR

Genera/spinal

 Intervention n=273: 

257/16

 Control

n=275:260/15

Other notes: NNIS 

SSI risk 

stratification.

Follow-up: 

During 

hospitalization, 

abdominal and 

perineal exams 

were performed 

daily by 

gynecological staff 

to assess for 

infection. If 

signs/symptoms 

developed, 

examiner 

collected samples 

from pelvic cavity 

and wound site 

for culture before 

initiating 

antimicrobial 

therapy.

After discharge: 90 

days 

postoperatively at 

the first, second 

and third months 

after surgery, vital 

signs, physical 
Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminated by the Centers for Disease Control and Prevention 

and should not be construed to represent any agency determination or policy. 53

Author

Year

(Data 

Extractor)

Study 

Design

Quality 

Score

Study Objective Population and Setting Intervention Results Comments

(LAVH or LAOC) for 

nonmalignant disease.

Exclusion Criteria: 

Women who had 

major surgery in the 

month before elective 

gynecologic surgery, 

had known or 

suspected 

hypersensitivity or 

intolerance to 

cephalosporin, or had 

any coexisting disease 

that would require 

antimicrobial therapy 

during the study. Also, 

patients who had 

taken antimicrobials 

the week before 

surgery

examination, and 

pelvic sonography 

were performed 

when patient 

returned to the 

clinic for 

evaluation.

Carroll 

200332

(ES)

RCT

1, 4, 8, 

9, 10

To clearly 

address the 

duration of 

antimicrobial 

prophylaxis 

(either 3 doses 

[1 day] or 15 

doses [3 days]) 

in patients with 

head and neck 

cancer 

requiring freeflap 

reconstruction 

of cancer 

Number of patients: 

N=74

Patient Characteristics: 

No statistically 

significant difference 

existed between study 

groups or between 

patients with and 

without complications 

(data listed below is 

for entire population 

(N).

·Age: y, Mean±SD: 

61.6±12.5 range 21-88 

years

Intervention group: n= 35

Short course (1 day): 900mg 

Clindamycin intravenously 

initiated immediately 

preoperatively to total 3 

doses every 8 hours.

Timing of intervention: Pre 

and postoperatively

Duration of intervention: 

From preoperatively to 

16-56 hours 

postoperatively.

Device/agent: Clindamycin

Monitoring intervention: NR

Control group: n= 39

SSI: (follow up: discharge or 

7days postop)

Wound infection

 Intervention: 4 (11%)

 Control: 4 (10%)

 P=0.99

Other infections:

Women were more likely 

than men to develop 

Remote Infections 

(specifically UTI) 25% vs. 

2%; P=0.004

Other/ remote infections 

(including UTI & 

Definitions: 

Head and neck 

wound and donor 

site evaluated for:

Wound color

1: normal

2: pink

3: red or swollen

Drainage

1: none

2: serious

3: purulent

Wound infection

A wound was 

considered 
Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminated by the Centers for Disease Control and Prevention 

and should not be construed to represent any agency determination or policy. 54

Author

Year

(Data 

Extractor)

Study 

Design

Quality 

Score

Study Objective Population and Setting Intervention Results Comments

defects. ·Gender (m/f): 46/28

·Obesity: NR

·Comorbidities: NR

Previous radiotherapy: 24 

(32%)

Flap Type: 

Fibula/jejunum/radial 

forearm/rectus: 

9/19/31/15

Tumor site: Buccal/floor 

of 

mouth/hypopharynx/ 

larynx/maxilla/ 

oropharynx/roof of 

mouth/ tongue: 

5/15/14/7/11/8/10/4

Procedures: Surgical 

ablation of head and 

neck malignancies 

with immediate freeflap reconstruction

including: radial 

forearm, jejunum, 

rectus and fibula by 

descending order of 

frequency.

Indications: (n)

Stage II/III/IV: 7/21/46

(91% stage III or IV)

Setting: 1 center

Location: USA

Dates: January 1, 1998-

April 30, 2001

Inclusion Criteria: 

Patients scheduled to 

undergo surgical 

Long Course (3 days) 900mg 

Clindamycin intravenously 

initiated preoperatively to 

total 15 doses every 8 

hours.

Standard preventive 

measures: NR

enterocolitis)

 Intervention: 4 (11%)

 Control: 4 (10%)

 P=0.99

Topic-specific outcomes: 

C. difficile enterocolitis: 1/74 

(1%) they don’t specify in 

which group

Reoperations: NR

Length of stay: NR

Mortality:

 Intervention: 1 (3%)

 Control: 1 (3%)

 P=0.99

Adverse events:

Pharyngocutaneous Fistula

 Intervention: 3/35 (9%)

 Control: 3/39 (8%)

 P=0.99

Postoperative fistula was 

more common in men but 

P=0.08

Flap Necrosis

 Intervention: 0 

 Control: 1 (3%)

 P=0.99

Vascular Compromise of flap

 Intervention: 2 (6%)

 Control: 1 (3%)

 P=0.99

infected when the 

color became red 

or the wound was 

swollen. A pink 

wound that 

developed 

purulent drainage 

was also 

considered 

infected.

Perioperative care: 

NR 

Other notes: Accrual 

of patients for the 

study was 

stopped when 

annual review of 

the data disclosed 

that differences 

between the 

study groups were 

much lower than 

those projected in 

initial sample size 

determinations. A

difference of 1%, 

recalculated 

estimate of 

sample size for 2 

sided significance 

level of 0,005 with 

80% power would 

require more than 

10,000 subjects in 

each treatment 
Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminated by the Centers for Disease Control and Prevention 

and should not be construed to represent any agency determination or policy. 55

Author

Year

(Data 

Extractor)

Study 

Design

Quality 

Score

Study Objective Population and Setting Intervention Results Comments

ablation of head and 

neck malignancies 

with immediate freeflap reconstruction

Exclusion Criteria: 

Patients undergoing 

secondary 

reconstruction and 

those whose tumor 

did not involve the 

mucous membranes of 

the upper 

aerodigestive tract

arm.

Follow-up: Wounds 

were evaluated 

daily for 7 days 

postoperatively 

(or until 

discharge) by a 

blinded faculty 

head and neck 

surgeon.

Hall

199830

(ES)

RCT

1, 2, 6, 

7, 8, 9

To compare the 

incidence of 

wound 

infection after 

emergency 

elective 

vascular 

surgery 

following the 

administration 

of the same 

agent as either 

short-term 

prophylaxis or a 

multiple dose 

regimen.

Number of patients: 

N=302

Patient Characteristics: 

Both groups were 

comparable with 

respect to putative 

risk factors for a 

wound infection at 

baseline and during 

the perioperative 

period.

·Age median (range) y

 Intervention: 70 (64-75)

 Control: 69 (64-76) 

·Gender (m/f)

 Intervention: 116/37

 Control: 103/46

·Obesity BMI (kg/m2)

 Intervention: 25 (22-27)

 Control: 24 (22-27)

·Comorbidities

IDDM: 

 Intervention: 3 (2%)

Intervention group: n= 153

Single Dose

3g ticarcillin/ 0.1g 

clavulanate by slow 

intravenous infusion (over 

30 minutes) immediately 

after the induction of 

anesthesia. Patients 

received an additional 

dose if the surgery was 

prolonged beyond 3 

hours.

Timing of intervention: Pre, 

intra and postoperatively

Duration of intervention: 

From immediately after 

the induction of 

anesthesia to vs. five days

in controls.

Device/agent: 3g ticarcillin/ 

0.1g clavulanate

Monitoring intervention: NR

Control group: n= 149

SSI: (follow up 42 days 

postop)

Overall rate of wound 

morbidity: (wound + minor 

wound): 101/302 (34%)

Wound infection: 43/302 

(14%)

 Intervention: 28 (18%)

 Control: 15 (10%)

 P=0.041

 Relative risk estimate 

(95%CI)

 = 2.00 (-1.02-3.92)

 Median time to 

presentation of wound 

infection: 13 days (range: 

2-43 days)

Minor wound infections: 

58/302 (19%)

 Intervention: 35 (23%)

 Control: 23 (15%)

Graft infection: 2/302 (<1%)

Definitions: 

Wound infections: 

discharge of pus or a 

serous discharge 

that contains 

pathogenic 

organisms

Graft infection: an 

overt clinical event 

characterized by the 

need for aggressive 

interventions and 

confirmed by 

microbiology.

Minor wound 

infections: Local 

abscess or serous 

discharge not 

meeting their 

established 

criteria for wound 

infection
Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminated by the Centers for Disease Control and Prevention 

and should not be construed to represent any agency determination or policy. 56

Author

Year

(Data 

Extractor)

Study 

Design

Quality 

Score

Study Objective Population and Setting Intervention Results Comments

 Control: 3 (2%)

NIDDM:

 Intervention: 31 (20%)

 Control: 16 (11%)

Current Smoker

 Intervention: 53 (35%)

 Control: 39 (26%)

Previous myocardial 

infarction

 Intervention: 38 (25%)

 Control: 37 (25%)

Previous stroke

 Intervention: 20 (13%)

 Control: 16 (11%)

Previous ischemic attack

 Intervention: 15 (10%)

 Control: 9 (6%)

Previous cardiovascular 

surgery

 Intervention: 62 (41%)

 Control: 65 (44%)

Operative events: 

Intervention = 153 

patients

Control =149 patients

Comparable with regards 

to operation type, 

duration, 

intraoperative shock, 

wound closure 

technique, total length 

of wounds and 

duration of drainage in 

days. 

Intervention n (%) vs. 

Control n (%)

Multiple Dose

3g ticarcillin/ 0.1g 

clavulanate by slow 

intravenous infusion (over 

30 minutes) immediately 

after the induction of 

anesthesia. Patients 

received an additional 

dose if the surgery was 

prolonged beyond 3 

hours. After the initial 

dose, patients received 3g 

ticarcillin/ 0.1g 

clavulanate intravenously 

at 6 hourly intervals for a 

maximum total of 20 

doses (i.e., until the lines 

are removed but<5 days)

Standard preventive 

measures:

Skin prep: preoperative 

chlorhexidine skin wash.

Wound closure & Drains: 

there was uniform wound 

closure and drain tubes 

did not exit through 

wounds.

ABX irrigation: No local 

irrigation of tissues with 

antibiotic solutions.

Diarrhea: Patients with 

postop diarrhea had 

stools evaluated for 

enteropathogens.

 Intervention: 1 (<1%)

 Control: 1 (<1%)

Patients undergoing lower 

limb surgery had greatest 

risk of wound infection 

(24/95 or 25%)

Other infections: NR

Topic-specific outcomes:

No major side effects 

associated with the 

parenteral administration 

of AMP

Diarrhea with C. difficile

 Intervention: 2 (1.3%)

 Control: 1 (0.7%)

Antimicrobial resistance: 

Authors state that they 

did not detect any 

appreciable difference in 

the resistance patterns of 

the isolates between 

groups (statistical 

significance not tested) 

Among several isolates 

from 25 patients are the 

following:

S. aureus

Intervention: 5/15 (33%)

Control: 4/10 (40%)

MRSA

Intervention: 1/5 SA (20%) or 

1/15 isolates (7%)

Control: 2/4 SA (50%) or 

2/10 isolates (20%)

Vascular surgery: All 

open arterial 

procedures.

Shock: (Dellinger 

1985) 

clinical signs of 

reduced 

peripheral 

perfusion plus any 

two of the 

following:

 Systolic blood 

pressure (BP) <80 

mm HG for 1 hour

 Pulse rate 

>120bmp (sinus 

minute rhythmia) 

for more than 1 

hour

 Urine output less 

than 80ml for any 4 

hour period

 Use of pressors to 

maintain the blood 

pressure for at least 

1 hour.

Obesity: Body mass 

index (BMI) weight/ 

the square of the 

height.

Insulin dependent 

diabetes mellitus 

(IDDM): an episode 

of ketoacidosis or 

dependence on 
Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminated by the Centers for Disease Control and Prevention 

and should not be construed to represent any agency determination or policy. 57

Author

Year

(Data 

Extractor)

Study 

Design

Quality 

Score

Study Objective Population and Setting Intervention Results Comments

Use of Cell saver:

 47 (31%) vs. 51(34%)

Peri-op blood transfusion

32 (21%) vs. 40 (27%)

Number of wounds per 

patient:

1: 86 (56%) vs. 83 (56%) 

2: 34 (22%) vs. 41 (28%)

3: 31 (20%) vs. 22 (15%)

4: 2 (1%) vs. 3 (2%)

Procedures: Emergency 

or Elective:

Abdominal aortic 

aneurysm: 86/ 302 

(28.5%)

Groin-distal bypass: 

73/302 (24.2%)

Aorto-groin bypass: 

49/302 (16.2%)

Carotid endarterectomy: 

37/302 (12.3%)

Miscellaneous lower 

limb: 28/302 (9.3%)

Groin procedures: 22/302 

(7.3%)

Other: 7/302 (2.3%)

Indications: NR

Setting: 1 hospital

Location: Australia

Dates: January 1993 –

October 1995

Inclusion Criteria: All 

adults undergoing 

Vascular surgery (all 

open arterial 

procedures.)

S epidermis (SE)

Intervention: 1/15 (7%)

Control: 3/15 (20%) 

Resistance not reported for 

SE

Reoperations:

 Intervention: 16 (10%)

 8/16 Amputation/ 

debridement of tissue

 5/16 Revision of graft

 2/16 Hemostasis

 0/16 CABG

 1/16 Intestinal Adhesions

 Control: 17 (11%)

 7/17 Amputation/ 

debridement of tissue

 3/17 Revision of graft

 4/17 Hemostasis

 2/17 CABG

 1/17 Intestinal Adhesions

Length of stay: median 

(range)

 Intervention: 9 (6-13

 Control: 9 (7-13%)

86% of patients admitted to 

ICU were discharged w/in 

48 hours.

Mortality:

 Intervention: 8 (5%)

 Control: 5 (3%)

No patient died as a result of 

a wound or graft 

infection.

Adverse events: 

Administration of 

insulin

Non-Insulin 

dependent diabetes 

mellitus (NIDDM):

indicated by a 

requirement for oral 

hypoglycemic 

medication

Length of stay = 

number of 

postoperative days 

in hospital 

Perioperative care: 

Nosocomial 

infections were 

managed in 

accordance with 

the institutional 

antimicrobial

guidelines.

Other notes: As

might be 

expected, the 

patients tended to 

be elderly and 

debilitated.

More intervention 

patients were 

smokers, NIDDM 

and had severe 

cardiac disease. 

Follow-up: 42 days 

after surgery
Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminated by the Centers for Disease Control and Prevention 

and should not be construed to represent any agency determination or policy. 58

Author

Year

(Data 

Extractor)

Study 

Design

Quality 

Score

Study Objective Population and Setting Intervention Results Comments

Exclusion Criteria: 

Patients undergoing 

endovascular 

procedures, 

administration of 

antimicrobial agents 

within 48 hours of 

surgery, a history of 

hypersensitivity to 

penicillin, and 

profound comorbidity.

antimicrobials

 Intervention: 37 (24%)

 Control: 27 (18%)

Requirement of wound 

dressing

 Intervention: 23 (15%)

 Control: 22 (15%)

 

Kow

1995 17

(ES)

RCT

1, 2, 6

To evaluate the 

efficacy of one 

dose of 

antimicrobial

vs. 3 doses 

covering the 

24h 

postoperative 

period using 

new an new 

antimicrobial

prophylaxis 

consisting of 

cefotaxime plus 

metronidazole 

or cefoxitin 

Number of patients: 

N=1010

Patient Characteristics

There was an even 

distribution of patients 

for each antimicrobial

regimen.

Procedures: Elective and 

emergency intraabdominal surgeries.

Setting: 2 hospitals.

Location: Australia

Dates: September 1989 -

January 1992

Inclusion Criteria: 

Patients 16 years and 

older, admitted to the 

two hospitals for all 

types of intraabdominal surgery 

(elective and 

emergency)

Exclusion Criteria: if 

there was a history of 

Intervention group: n=516

1dose CFX: n=252: 2g 

cefoxitin intravenously on 

induction of anesthesia

1dose CTX+M: n=264: 1g 

cefotaxime + 500mg 

metronidazole on 

induction of anesthesia 

Timing of intervention: pre 

and postop

Duration of intervention: 

preop and up to 12h 

postop

Device/agent: cefoxitin or 

cefotaxime plus 

metronidazole

Control group: n=

3dose CFX: n=254: 2g 

cefoxitin intravenously on 

induction of anesthesia 

followed by another 2g at 

6 & 12h postop

3dose CTX+M: n=240: 1g 

cefotaxime + 500mg 

SSI 

All procedures

Total: 58/1010 (5.7%)

1dose: 31/516

3dose: 27/494

P>0.19

1dose CFX: 17/252 (6.7%)

3dose CFX: 17/254 (6.7%)

1dose CTX+M: 14/264 (5.3%)

3dose CTX+M: 10/240 (4.2%)

Elective colorectal 

procedures

CTX+M: suggests no 

difference

Total: 12/138 (8.7%); 

1dose: 5/71(7.0%) 

7/67(10.4%); p =0.48 (28-41 

day follow up)

Definitions:

Wound infection: the 

presence of 

purulent 

discharge from 

the wound or a 

serous discharge 

with positive 

culture of 

pathogenic 

organisms.

Perioperative care : 

NR 

Other notes: Study 

was not 

sufficiently 

powered for 

smaller sub 

analyses.

Follow-up: 28-41 day 

follow-up.
Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminated by the Centers for Disease Control and Prevention 

and should not be construed to represent any agency determination or policy. 59

Author

Year

(Data 

Extractor)

Study 

Design

Quality 

Score

Study Objective Population and Setting Intervention Results Comments

allergy to 

cephalosporins, 

penicillin, or 

metronidazole, had 

received 

antimicrobials. Also if 

operative findings 

indicated the need for 

prolonged 

antimicrobials, or the 

need for delayed 

primary wound 

closure were 

excluded. Also if a 

patient died in the 14 

days after the 

operation with no 

evidence of infection, 

they were excluded 

from the analysis.

metronidazole on 

induction of anesthesia 

followed by 1g of 

cefotaxime at 6 & 12h 

postop.

Standard preventive 

measures:

Skin prep: PI Solution

Plastic wound protectors: 

not allowed.

Bowel Prep: all patients 

undergoing elective 

colorectal surgery were 

given mechanical (nonantimicrobial) bowel prep 

of up to 3 L of a colonic 

lavage solution prior to 

operation.

CFX: suggests no difference: 

Total: 16/135 (11.9%); 

1dose: 8/65(12.3%) 

3dose: 8/70(11.4%); 

p=0.87

Emergency colorectal 

procedures: 

Total: 6/46 (13.0%); 

1dose: 4/21 (19.0%) vs.

3dose: 2/25 (8.0%); 

p=0.28 

Appendectomy:

Drug regimen 1: n=112: 

 1doseCFX: 4/54

 3dose CFX: 4/58

Drug regimen 2: n=117 

 1doseCTX+M: 2/63 

 3dose CTX+M: 0/54

Esophageal, gastric, and 

small bowel surgery

Drug regimen 1: n=82: 

 1doseCFX: 1/42

 3dose CFX: 3/40

Drug regimen 2: n=81 

 1doseCTX+M: 1/41 

 3dose CTX+M: 1/41

Biliary Surgery:

Drug regimen 1: n=158: 

 1doseCFX: 2/83

 3dose CFX: 2/75

Drug regimen 2: n=140 

 1doseCTX+M: 3/76 
Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminated by the Centers for Disease Control and Prevention 

and should not be construed to represent any agency determination or policy. 60

Author

Year

(Data 

Extractor)

Study 

Design

Quality 

Score

Study Objective Population and Setting Intervention Results Comments

 3dose CTX+M: 0/64

McArdle

1995 39

(ES)

RCT

1, 7, 8

To compare an 

oral 

ciprofloxacin/ 

parenteral 

metronidazole 

regimen with a 

parenteral 

aminoglycoside

/metronidazole 

combination 

commonly used 

for prophylaxis 

in colorectal 

surgery, and 

the value of 

1day versus 3 

days of 

antimicrobial 

cover.

Number of patients N=87

Patient Characteristics: 

the groups were 

comparable in in 

terms of 

characteristics.

Procedures: colorectal 

surgery

Setting: 1 university 

hospital

Location: United Kingdom

Dates: NR

Inclusion Criteria: 

patients undergoing 

colorectal surgery.

Exclusion Criteria: NR

Intervention group: n=45

Patients administered 

gentamicin 120mg and 

metronidazole 500mg 

intravenously at induction 

of anesthesia followed by 

gentamicin 80mg and 

metronidazole 500mg at 

8h & 16h post-op (3doses 

total)

Timing of intervention: pre 

and postop

Duration of intervention: 1 

shot or 3 days postop

Device/agent: gentamicin 

120mg or 80mg and 

metronidazole 500mg

Control group: n=42

Patients administered 

gentamicin 120mg and 

metronidazole 500mg 

intravenously at induction 

of anesthesia followed by 

80mg gentamicin and 

metronidazole 500mg 

3times/ day for 3 days 

SSI 

Total: 20/87 (23.0%)

 Single day: 13/45(28.9%) 

 3day: 7/42(16.7%); 

 p=0.18 

Definitions: 

Wound sepsis: the 

presence of pus 

either discharging 

spontaneously or 

requiring 

drainage.

Major wound sepsis: 

the discharge of 

pus with 

constitutional 

disturbance

Minor wound 

infections: 

patients with 

cellulitis and a 

positive wound 

culture.

Perioperative care: 

NR 

Other notes: NR

Follow-up: 4 weeks 

post discharge
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and should not be construed to represent any agency determination or policy. 61

Author

Year

(Data 

Extractor)

Study 

Design

Quality 

Score

Study Objective Population and Setting Intervention Results Comments

postop.

Standard preventive 

measures: NR

Nooyen 

1994 25

(ES)

RCT

1, 2, 4, 

7, 8

To compare a 

single dose of 

cefuroxime 

with their 

currently 

recommended 

3-day course of 

cefuroxime 

with regard to 

effectiveness in 

preventing 

postoperative 

wound 

infection.

Number of patients: 

N=844

Patient Characteristics: 

Risk factors and 

patient characteristics 

were similar between 

groups.

·Age range

 Intervention: 34-86

 Control: 33-86

Age>70 years n (%)

 Intervention: 79 (18.9%)

 Control: 86 (20.2%)

·Gender (m/f)

 Intervention: 329/90

 Control: 353/72

·Obesity NR

·Comorbidities

Diabetes Mellitus

 Intervention: 34 (8.1%)

 Control: 41 (9.6%)

COPD

 Intervention: 14 (3.3%)

 Control: 11 (2.6%)

History of smoking

 Intervention: 354 

Intervention group: n=419

After placement of a 

peripheral line in the 

operating room, patients 

received 20mg/kg 

cefuroxime intravenously 

at induction of 

anesthesia.

Timing of intervention: Pre, 

intra and postoperatively

Duration of intervention: 

From induction of 

anesthesia to 3 days 

postop

Device/agent: Cefuroxime

Monitoring intervention: NR

Control group: n=425

After placement of a 

peripheral line in the 

operating room, patients 

received 20mg/kg 

cefuroxime intravenously 

at induction of anesthesia 

then continued 

cefuroxime three times a 

day intravenously for 3 

SSI: (7 day follow up)

Overall (sternal + leg 

wounds): 54/844 (6.3%) 

Note: authors report it as 

5.3% using N=1016 even 

though they excluded 172 

patient from all other 

final analysis ( see NOTE 

at bottom of results)

Sternal Site

Total complications of 

healing

 Intervention: 58 (13.8%)

 Control: 56 (13.2%)

 P=0.35

Mediastinitis

 Intervention: 2 (0.5%)

 Control: 0

 No cases of late onset 

mediastinitis were 

reported after discharge 

from hospital.(but they 

don’t indicate how long 

postop)

Wound infection

 Intervention: 5 (1.2%)

Definitions: 

Wound infection: 

diagnosed if all of 

the following 

criteria were met:

 Redness

 Purulent discharge

 Positive culture (if 

pathogenic 

organisms were 

isolated)

Infection of the 

sternum was 

differentiated into 

superficial infection 

or mediastinitis

Mediastinitis:

fever>38°C, chest 

pain or sternal 

instability and a 

purulent discharge 

from the 

mediastinal area 

from which 

pathogenic 

microorganisms 
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and should not be construed to represent any agency determination or policy. 62

Author

Year

(Data 

Extractor)

Study 

Design

Quality 

Score

Study Objective Population and Setting Intervention Results Comments

(84.5%)

 Control: 363 (82.4%)

Use of corticosteroids

 Intervention: 10 (2.4%)

 Control: 10 

(2.4%)Operative:

Primary/ re-operation

 Intervention: 398/21

 Control: 398/27

Emergency/ elective

 Intervention: 411/8

 Control: 407/18

 (18 vs. 8, P<0.08) 

though the rate of 

infection was not 

higher among 

emergency 

procedures.

Donor vessels

 Leg veins only// Left 

internal mammary 

artery +/- leg veins// 

Both internal 

mammary arteries +/-

leg veins

 Intervention: 

94//223//102

 Control: 118//212//95

Procedures: Coronary 

Artery Bypass Grafting 

(CABG)

Indications: NR

Setting: 1 hospital

Location: The 

Netherlands.

consecutive days.

Standard preventive 

measures:

SA Decolonization: Starting 

two days prior to surgery, 

all patients undergoing 

cardiopulmonary surgery 

are treated intra-nasally 

with a cream consisting of 

0.1% chlorhexidine and 

0.5% neomycin to 

eliminate possible 

Staphylococcus aureus.

Closure: All skin wounds 

were closed with intracutaneous reabsorbable 

sutures

Jugular Vein Catheter 

Removal: catheter was 

removed after 48 hours in 

all cases

 Control: 4 (0.9%)

Minor Complication

 Intervention: 51 (12.2%)

 Control: 52 (12.2%)

Donor site leg 

 Intervention: n=377

 Control: n=389

Total complications of 

healing

 Intervention: 118 (31.3%)

 Control: 130 (33.4%)

 P=0.41

Wound infection

 Intervention: 5 (1.3%)

 Control: 2 (0.5%)

Minor complications

 Intervention: 95 (25.2%)

 Control: 110 (28.3%)

Wound dehiscence

 Intervention: 18 (4.8%)

 Control: 18 (4.6%)

Other infections: 

UTI

 Intervention: 4 (1.0%)

 Control: 1 (0.2%)

Respiratory tract infection

 Intervention: 5 (1.3%)

 Control: 3 (0.7%)

Topic-specific outcomes: NR

Reoperations: NR-See NOTE 

below

Length of stay: NR

Mortality: none- See NOTE 

below

Adverse events: NR- see 

could be isolated.

Respiratory Tract 

infection: If 

patients were 

febrile, Gram stain 

of sputum 

demonstrated 

many 

polymorphonucle

ar leukocytes and 

a predominant 

organism, and the 

chest X-ray 

showed a new 

pulmonary 

infiltration

Urinary Tract 

Infection (UTI): if 

the urine culture 

was positive (≥105

cfu/ml) in the 

presence of fever 

for which no 

other cause could 

be found.

Perioperative care: 

Graft: The internal 

mammary artery 

graft, when used, 

was harvested on 

a pedicle of soft 

tissue equal in 

width to that of

both mammary 

veins. Leg veins 

were obtained by 
Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminated by the Centers for Disease Control and Prevention 

and should not be construed to represent any agency determination or policy. 63

Author

Year

(Data 

Extractor)

Study 

Design

Quality 

Score

Study Objective Population and Setting Intervention Results Comments

Dates: October 1989 -

December 1990

Inclusion Criteria: All 

patients undergoing 

coronary artery bypass 

grafting (CABG) 

including elective and 

emergency surgery, 

primary and 

reoperation.

Exclusion Criteria: 

Exclusion from 

randomization:

Refusal of consent, 

administration of 

systemic antimicrobial 

treatment within the 

previous 48 h, 

hypersensitivity to 

cefuroxime or the 

presence of prosthetic 

valves or a vascular 

prosthesis.

NOTE below

NOTE: Of 1016 patients 

included in the study, 172 

were excluded from final 

analysis for the following 

reasons (in some more 

than one reason was 

present):

Reason: Intervention 

(n)/control (n)

Chest open>6h: 42/27

Repeat thoracotomy within 7 

days: 22/30

Intra-aortic balloon pump: 

8/6

Artificial ventilation >24h: 

7/10

Death within 7d (noninfectious): 1/8 ( all died 

in OR or did not come off 

IABP)

Additional antimicrobials: 

15/3

Other operative procedure: 

0/5

No wound inspection: 1/1

They report that neither

wound infection nor 

mediastinitis occurred in 

any of these patients

standard 

measures

Postoperative 

samples of 

sputum and urine 

and if necessary 

wound exudates 

were collected on 

first and following 

days.

Other notes: See 

results for reasons 

for exclusion from 

final analysis

Follow-up: On the 

seventh day 

postop, the 

sternotomy and 

donor site 

wounds were 

examined for 

healing, redness, 

discharge of fluid 

without signs of 

infection, or 

infection by a 

blinded physician
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and should not be construed to represent any agency determination or policy. 64

Author

Year

(Data 

Extractor)

Study 

Design

Quality 

Score

Study Objective Population and Setting Intervention Results Comments

Bernard 

1994 28

(ES)

RCT

1, 2, 3, 

4, 5, 7, 

8, 9

To determine 

whether a 

longer 

antimicrobial 

prophylaxis 

regimen for 48 

hours after 

pulmonary 

operation 

decreases the 

rate of deep 

infections in 

pleura, bronchi

and 

parenchyma.

Number of patients: 

N=203

Patient Characteristics: 

All characteristics 

were balanced except 

those with a P-value 

below

·Age mean (range) years

 Intervention: 56 (19-78)

 Control: 61 (17-81)

 P=0.02

·Gender (m/f)

 Intervention: 91/10

 Control: 85/17

·Obesity: NR

·Comorbidities

Tobacco packs/year mean 

(range)

 Intervention: 33 (0-120)

 Control: 33 (0-120)

Quit Smoking more than 

1 month

 Intervention: 18 (18%)

 Control: 15 (15%)

 P(not significant)

Alcohol: (L/day) mean 

(range)

 Intervention: 0.4 (0-3)

 Control: 0.5 (0-5)

Chronic bronchitis: n (%)

 Intervention: 30 (29.7%)

 Control: 36 (35.3%)

Diabetes: n (%)

 Intervention: 5 (5.0%)

 Control: 4 (3.92%)

Cardiac insufficiency

Intervention group: n= 101

48 hour cefuroxime

A 1.5g dose of cefuroxime 

was delivered 

intravenously at the 

moment of induction of 

anesthesia. A second 

dose was systematically 

delivered 2 hours later to 

obtain high seric 

concentrations until the 

end of the procedure. 

1.5g cefuroxime was 

given every 6 hours after 

the operation for 48 

hours. The first 

postoperative infusion 

was given exactly 6 hours 

after the second infusion.

Timing of intervention: Pre, 

intra and postoperatively

Duration of intervention: 

From induction of 

anesthesia until 48 hours 

after the second dose 

during surgery

Device/agent: Cefuroxime

Monitoring intervention: NR

Control group: n=102

Flash cefuroxime.

A 1.5g dose of cefuroxime 

was delivered 

intravenously at the 

moment of induction of 

anesthesia. A second 

dose was systematically 

SSI: (follow up 8 days)

Total deep infections:

 Intervention: 47/101 46%

 Control: 66/102 (65%)

 P=0.005

Difference in infection rates 

(19%±11%) remained 

significant (p=-.01) after 

adjusting for multiple 

variables)

Wound infection

 Intervention: 1 (1%)

 Control: 1 (1%)

 P=0.9

Empyema

 Intervention: 1 (1%)

 Control: 6 (6%)

 P=0.03

Pneumonia

 Intervention: 17 (17%)

 Control: 31 (30%)

 P=0.01

Severe Bronchopneumonia

 Intervention: 25 (25%)

 Control: 25 (25%)

 P=0.9

Fever (>38oC)

 Intervention: 5 (5%)

 Control: 10 (10%)

 P=0.09

Total Deep Infection

 Intervention: 56 (19-78)

 Control: 61 (17-81)

 P=0.005 

Other infections:

Definitions: Deep 

Infections: Wound 

infections + 

Pneumonia + 

severe 

bronchopneumoni

a +empyema+

fistula)

Pneumonia: defined 

on the basis of the 

x-ray film with 

specific 

parenchymal 

features 

associated with 

temperatures 

between 37.5o–

38oC.

X-ray appearance

Class 1: normal

Class 2: moderate 

infiltrate

Class 3: important 

infiltrate/atelecta

sis

Severe 

Bronchopneumon

ia an association 

of purulent 

expectorations 

and atelectasis on 

the plain chest xray film 

associated with a 

temperature 

higher than 38oC.
Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminated by the Centers for Disease Control and Prevention 

and should not be construed to represent any agency determination or policy. 65

Author

Year

(Data 

Extractor)

Study 

Design

Quality 

Score

Study Objective Population and Setting Intervention Results Comments

 Intervention: 5 (5.0%)

 Control: 6 (5.9%)

Previous Chemotherapy

 Intervention: 16 (15.8%)

 Control: 8 (7.8%)

 P=0.07 

Previous Radiotherapy

 Intervention: 5 (5.0%)

 Control: 3 (2.9%)

Transfusion (units) 

mean(range)

Intervention: 0.32(0-8)

Control: 0.5 (0-12)

Procedures: 

Lobectomy: 108 (53.2%)

Pneumonectomy: 71 

(35.0%)

Wedge resection: 23 

(11.3%)

Indications: 

Lung cancer: 160 (78.8%)

Lung metastasis: 17 

(8.4%)

Benign tumor: 20 (9.9%)

Chronic pulmonary 

emphysema with 

blebs: 6 (3.0%)

Setting: 1 hospital

Location: France

Dates: January 1, 1991-

June 30, 1992

Inclusion Criteria: All 

patients undergoing 

thoracotomy with lung 

resection for lung 

cancer, lung 

delivered 2 hours later to 

obtain high seric 

concentrations until the 

end of the procedure. A 

placebo was administered 

every 6 hours after the 

operation for 48 hours.. 

Standard preventive 

measures:

Skin prep: local cutaneous 

disinfection with 

povidone-iodine at 12 and 

1 hour pre-op.

Analgesic: all patients were 

given the same analgesia: 

Morphinic antalgic drugs 

were infused 

intravenously every 4 

hours.

Fistulas

 Intervention: 2 (2%)

 Control: 7 (7%)

 P=0.045

Topic-specific outcomes:

Antimicrobial resistance: 

Pathogens cultured from 

pleura, bronchi, drains 

and blood were similar in 

the two groups. Did not 

specify antimicrobial 

resistance.

Reoperations: NR

Length of stay:

 Intervention: 13±1 days

 Control: 15±1.6 days

Mortality: 4/203 (2%)

 Intervention: 3 (3%)

 Control: 1 (1%)

 1/4: Pulmonary embolism

 1/4: Cerebral hemorrhage

 1/4: Mesenteric infarction

 1/4: Respiratory failure 

with acute 

bronchopneumonia

Adverse events: No side 

effects of the treatment 

were noted.

Duration of chest drainage:

 Intervention: 5.5±0.8 days

 Control: 5.7±1 days

Empyemas and 

septicemias: when 

associated with a 

temperature 

higher than 38oC. 

As soon as a 

septic condition, 

bacteriologic 

samples were 

obtained from 

expectorations,

pleura, drains, 

and blood.

Perioperative care: 

Respiratory recovery: 

aerosols were 

given to each 

patient on a 

regular basis and 

a respiratory 

program of 

physiotherapy 

followed.

Other notes: 

Statistical

a & β errors fixed at 

5% level. 

Infection 

estimated risk was 

30% with aim to 

reduce risk to 10% 

(20% reduction). 

Needed to include 

200 patients (total 

or each arm?)

Five patients 
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and should not be construed to represent any agency determination or policy. 66

Author

Year

(Data 

Extractor)

Study 

Design

Quality 

Score

Study Objective Population and Setting Intervention Results Comments

metastasis or chronic 

pulmonary 

emphysema with 

blebs.

Exclusion Criteria: 

Temperature > 38oC, 

purulent 

expectoration, 

curative antimicrobial 

therapy that had been 

stopped less than 8 

days prior, infected 

tumor, purulent 

pleurisy, lung abscess, 

bronchiectasis, 

exploratory 

thoracotomy, 

mediastinal tumor, 

chronic renal 

insufficiency, or βlactamase allergy.

included in the 

analysis (2 

intervention, 5 

controls were not 

given full 

treatment 

because of 

missing 

prescriptions)

Follow-up Abnormal 

pulmonary 

features on plain 

x-ray, 

expectorations 

and temperature 

were recorded 

daily from 

postoperative day 

3 up to 8 days) No 

specific about 

wound follow up.

Karran

1993 42

(ES)

RCT

1, 7, 8

To investigate 

the use of the 

antimicrobial 

imipenem for 

perioperative 

prophylaxis in 

elective 

colorectal 

surgery at both 

single dose and 

multiple dose 

regimens.

Number of patients: 

N=227

Patient Characteristics

Patients were well 

matched for 

demographic and 

surgical data collected.

Procedures: elective 

colorectal

Setting: 1 University 

hospital

Location: UK

Dates: NR

Inclusion Criteria: 

Intervention group: n=113

2dose: patients received 

intravenously imipenem 

1g at induction of 

anesthesia with a single 

further dose of imipenem 

1g at 3h postop.

Timing of intervention: pre 

and postop

Duration of intervention: up 

to 16h postop

Device/agent: imipenem

Control group: n=114

4dose: patients received 

SSI 

All SSI (some patients 

suffered more than 1 

infection) 

2dose: 34/113 (30.1%) 

4dose: 29/114 (25.4%);

Intra-pelvic abscess: 

2dose: 2/113 (1.8%) 

4dose: 2/114 (1.8%);

Intra-abdominal abscess 

2dose: 2/113 (1.8%) 

4dose: 1/114 (0.9%); 

Definitions: 

Surgical Infection: if a

purulent 

discharge 

occurred from the 

wound, a positive 

bacteriological 

culture was 

obtained, or a 

deep abscess 

developed at the 

site of operation.

Perioperative care: 
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and should not be construed to represent any agency determination or policy. 67

Author

Year

(Data 

Extractor)

Study 

Design

Quality 

Score

Study Objective Population and Setting Intervention Results Comments

Patients over 18 years 

of age undergoing 

elective colorectal 

surgery.

Exclusion Criteria: 

Pregnancy, known 

allergy to any study 

drug, concomitant 

infection, serious 

comorbidity or 

inflammatory bowel 

disease. Also, patients 

who had been treated 

with antimicrobials in 

the preceding 72h or 

who had received 

steroids, 

antineoplastic agents 

or radiotherapy before 

surgery.

imipenem 1g 

intravenously at induction 

of anesthesia with further 

doses and of imipenem: 

1g at 3h postop and 

500mg at 8h and 16h 

postop

Standard preventive 

measures: skin prep: use 

of antiseptic lavage was 

left to the discretion of 

the operating surgeon.

p=0.56; 

Peritonitis 

2dose: 0/113 

4dose: 1/114 (0.9%)

Abdominal wound: 

2dose: 23/113 (19.5%)

4dose: 22/114 (19.3); 

p=0.84

Perineal wound:

2dose: 7/113 (6.2%) 

4dose: 3/114 (2.6%);

p=0.20

Adverse events

Adverse events possibly 

related to antimicrobial 

agent included 2 patients 

with phlebitis in the group 

receiving <24 AMP and in 

the group receiving longer 

AMP 2 cases of 

hypotension, 1 phlebitis, 

1 erythema, and 1 rash

NR

Other notes: None

Follow-up: 6-8 weeks 

postop

Mayer

1993 22

(ES)

RCT

1, 7

To perform a 

prospective 

randomized 

study 

comparing 

single dose 

antimicrobials 

prophylaxis 

with multipledose regimen in 

Number of patients: 

n=66

Patient Characteristics

Groups were not 

significantly different.

Procedures: Radical 

surgery for a 

gynecological 

malignancy

Setting: 1 university 

Intervention group: n=37

1dose: 4g piperacillin and 

800mg tinidazole 

intravenously 30 min 

before surgery

Timing of intervention: pre 

and postop

Duration of intervention: 1 

dose or 3 does. (up to 16h 

postop)

SSI 

1 abdominal wound infection 

was reported in each 

group 

1dose: 1/37 (3.0%)

3dose: 1/29 (3.5%)

Length of stay:

No differences: 

Definitions: NR

Perioperative care: 

nr 

Other notes: none

Follow-up: 8 days 

postop
Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminated by the Centers for Disease Control and Prevention 

and should not be construed to represent any agency determination or policy. 68

Author

Year

(Data 

Extractor)

Study 

Design

Quality 

Score

Study Objective Population and Setting Intervention Results Comments

patients 

undergoing 

radical surgery 

for gynecologic 

malignancy

hospital

Location: Austria

Dates: June 1987 –

September 1988

Inclusion Criteria: 

Patients undergoing 

radical surgery for a 

gynecological 

malignancy.

Exclusion Criteria: 

Patients who had 

infections within the 

last two weeks, 

received 

antimicrobials or had a 

history of allergic 

reaction to either 

study antimicrobial. 

Also if radical surgery 

was not possible or 

indicated.

Device/agent: piperacillin 

and tinidazole

Control group: n=29 

patients who received 4g 

piperacillin and 800 mg 

tinidazole 30 min before 

surgery and at 8 & 16h 

postop.

Standard preventive 

measures: NR

1dose: 18 days (range 12-23)

3dose: 19 days (range, 12-23 

days)

Bates

1992 20

(ES)

RCT

1, 2, 4, 

7, 8

To study a large 

number of 

patients in two 

hospitals within 

the same health 

district to 

determine if 

there is a 

significant 

difference 

between single 

and multiple 

dose regimes of 

amoxicillin 

Number of patients: 

N=900

Patient Characteristics: 

patients were 

matched between 

groups except for:

·Age: age>80y

 1 dose: 57/446 (12.8%)

 3 dose: 46/550 (8.4%)

Inflamed appendix

 1 dose: 71/114 (62%)

 3 dose: 101/133 (76%)

Dose violation

 1 dose: 3/446 (0.7%)

Intervention group: n=449

One dose of antimicrobials 

given on induction of 

anesthesia 

Timing of intervention: Pre 

and post op

Duration of intervention: 1 

pre op dose or 16h 

postop.

Device/agent: augmentin 

(1:10 combination of 

amoxicillin and clavulanic 

acid.)

Control group: N = 551

SSI 

All procedures:

None: 48/449

≤24h: 49/451

Colorectal Sub-Population:

(N=224) in at-risk abdominal 

surgery 

 1 dose: 23/113(20.4%)

 3 doses: 17/111(15.3%)

 P>0.2 

Appendectomy SubPopulation: (n=247): 

 1 dose: 11/114 (9.6%) 

Definitions: 

Wound sepsis: Major 

minor or late

Perioperative care: 

NR 

Other notes: None

Follow-up: 1 month
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and should not be construed to represent any agency determination or policy. 69

Author

Year

(Data 

Extractor)

Study 

Design

Quality 

Score

Study Objective Population and Setting Intervention Results Comments

250mg/ 

clavulanic acid 

125mg for 

prophylaxis in 

at-risk surgery.

 3 dose: 13/550 (2.4%)

Procedures: 

Appendectomies and 

all open gastric, 

esophageal, colonic or 

biliary surgery. All 

patients coming to 

laparotomy for 

intestinal obstruction 

including that due to 

strangulated hernia 

were entered into the 

study as well as 

patients with intraabdominal malignancy

Setting: 2 General 

Hospitals

Location: United Kingdom

Dates: May 1986 – June 

1988

Inclusion Criteria: All 

patients aged 16 or 

over admitted under 2 

surgical firms at 2 

adjacent district 

general hospitals for 

at-risk abdominal 

surgery with potential 

opening of a viscus.

Exclusion Criteria: All 

patients known to be 

allergic to penicillin. If 

patients had received 

antimicrobials within 

the previous 48h or if 

the surgeon 

Three doses of antimicrobials 

with the first given on 

induction of anesthesia 

and two additional 

injections at 8 & 16h 

later.

Standard preventive 

measures: NR

 3 dose: 21/133(15.8%)

 p=0.16
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and should not be construed to represent any agency determination or policy. 70

Author

Year

(Data 

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Study 

Design

Quality 

Score

Study Objective Population and Setting Intervention Results Comments

considered that preoperative 

antimicrobial 

administration were 

essential, they were 

also excluded. Also, 

declination of consent 

was excluded although 

all received 

prophylactic 

antimicrobials. 

Patients found to have 

purulent (fecal) 

peritonitis were 

withdrawn from the 

study 

Turano

1992 24

(ES)

RCT

1

To compare the 

efficacy and 

safety of two 

schedules of 

prophylactic 

cefotaxime in 

abdominal 

gynecologic and 

urologic surgery

Number of patients: 

N=608

Patient Characteristics

Recorded, not reported

Procedures: unspecified 

gynecologic 

procedures.

Setting: 226 Surgical 

units

Location: Italy

Dates: January 1, 1990 –

June 30, 1991

Inclusion Criteria: 

patients of any age 

undergoing 

gynecologic 

procedures 

(abdominal and 

vaginal hysterectomy 

and myomectomy.)

Intervention group: n=385

1dose: 1g cefotaxime 

intravenously 30 min 

before incision and might 

be repeated in 6h if the 

surgery lasted more than 

3h.

Timing of intervention: pre 

and postop

Duration of intervention: 

preop or 

Device/agent: cefotaxime

Control group: n=223

3dose: 1g cefotaxime 

intravenously 30 min 

before incision and 1.g 

doses at 6 and 12h 

postop. (3doses total).

Standard preventive 

SSI 

All Surgeries

1dose: 28/1802

3dose: 39/1765

subpopulation of 608 

patients undergoing 

unspecified gynecologic 

procedures, 

1dose: 12/385

3dose: 4/223

 p=0.53

Definitions:

Wound infection: 

discharge of 

serous or 

seropurulent 

material from the 

wound within 7 

days of operation.

Perioperative care : 

NR

Other notes: None

Follow-up: minimum 

7 day follow-up 

(or until 

discharge).
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and should not be construed to represent any agency determination or policy. 71

Author

Year

(Data 

Extractor)

Study 

Design

Quality 

Score

Study Objective Population and Setting Intervention Results Comments

Exclusion Criteria: 

known or suspected βlactam sensitivity, 

treatment with any 

antimicrobial in the 7 

days preceding 

surgery, requirement 

for combination 

antimicrobial 

treatment resulting 

from the nature of the 

patient’s condition or 

type of surgical 

procedures (e.g. 

immunosuppression 

or colorectal surgery) 

or terminal illness.

measures: NR

Wymenga

1992 15

(ES)

RCT

1, 2, 7, 

8

To establish the 

efficacy of a 

single 

perioperative 

antimicrobial 

dose for 

infection 

prophylaxis in 

joint 

replacement 

with a 

randomized, 

controlled, 

multicenter 

study.

Number of patients: 

N=2651

Patient Characteristics

The two trial arms were 

well matched with 

respect to the general 

and orthopedic 

diagnoses, risk factors 

and medications.

Procedures: THA, TKA 

and hemiarthroplasty 

procedures

Setting: 27 hospitals

Location: The 

Netherlands

Dates: July 1, 1986 – July 

1, 1988

Inclusion Criteria: 

Intervention group: n=1327

1dose: 1500mg cefuroxime 

given intravenously upon 

induction of anesthesia 

30min before the 

operation

Timing of intervention: pre 

and postop

Duration of intervention: 

preop and up to 16h 

postop

Device/agent: cefuroxime

Control group: n=1327

3dose: 1500mg cefuroxime 

given intravenously upon 

induction of anesthesia 

30min before the 

operation then 750mg 

SSI 

1dose: 11/1327 (0.83%) 

3dose: 6/1324(0.45%); 

p=0.17; 

RR: 1.83, 95%CI (0.68-4.93). 

Definitions: 

Confirmed joint 

sepsis: a positive 

bacteriologic 

culture at 

reoperation or a 

draining sinus

Strong evidence of 

sepsis: four or 

more possible 

signs of infection: 

Category I: in 

patients who only 

showed two or 

three possible 

signs of sepsis; 

Category II: a 

definite diagnosis 
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and should not be construed to represent any agency determination or policy. 72

Author

Year

(Data 

Extractor)

Study 

Design

Quality 

Score

Study Objective Population and Setting Intervention Results Comments

Patients undergoing 

total hip replacement, 

hemiarthroplasty of 

the hip or total knee 

arthroplasty

Exclusion Criteria: allergy 

to cephalosporin, 

penicillin anaphylaxis, 

the use of 

antimicrobials less 

than 48h before the 

operation, use of 

perioperative 

antimicrobial 

administration other 

than cefuroxime, 

malignancy, former or 

current sepsis in the 

joint and the use of 

gentamicinimpregnated bone 

cement for prosthetic 

fixation.

given at 8 & 16h postop.

Standard preventive 

measures: 

AMP Skin prep: in 3 centers, 

the wound was rinsed 

with a fluid containing an 

antimicrobial, whereas 2 

centers used PI to rinse 

the wound. 

could not be 

made; Category 

III: were not 

suspected of 

having joint 

sepsis.

Wound infection in 

postop period: 

erythema more 

than 1cm from 

the incision.

Perioperative care: 

NR 

Other notes: Study 

was sufficiently 

powered.

Follow-up: 13 

months

Aberg

1991 21

(ES)

RCT

1, 7, 8

To compare the 

tripe versus 

single dose of 

cefuroxime 

(with the 

addition of 

metronidazole 

for the 

surgeries of the 

jejunum, ileum, 

colon and 

rectum-anus). 

Concomitantly 

Number of patients: 

N=415 patients; 428 

operations

Patient Characteristics

Patients were well 

matched between 

groups.

Procedures: laparotomy, 

vagotomy, 

gastrectomy, gastric 

banding, other gastric, 

cholecystectomy, 

choledochal surgery, 

Intervention group: n= 200

1 dose of cefuroxime (with 

the addition of 

metronidazole for surgery 

of the jejunum, ileum, 

colon, and rectum-anus.

Timing of intervention

Duration of intervention

Device/agent: cefuroxime 

(with metronidazole for 

rectal surgeries)

Control group: n=215

3 doses of cefuroxime (with 

SSI: 

All Procedures:

1dose: 8/207

3dose:15/221

subanalysis of 48 elective 

rectal surgery patients: 

1dose: 2/19(10.5%) 

3dose: 1/29(3.4%); 

p=0.35

subanalysis gastric 

procedures (n=64) 

Definitions: 

Deep surgical sepsis: 

peritonitis, intraabdominal 

abscess, or 

septicemia. 

Perioperative care: 

NR 

Other notes: None

Follow-up: within 1 

month
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and should not be construed to represent any agency determination or policy. 73

Author

Year

(Data 

Extractor)

Study 

Design

Quality 

Score

Study Objective Population and Setting Intervention Results Comments

to introduce a 

system for 

continuous 

surveillance of 

postoperative 

wound 

infections.

pancreatectomy, 

surgery of jejunum, 

ileum, or colon, rectal 

anterior resection, 

rectal amputation.

Setting: 1 county 

hospital

Location: Sweden

Dates: February 1988 –

May 1990

Inclusion Criteria: 

Consecutive patients 

16 years or older 

scheduled for elective 

abdominal surgery 

during the study 

dates.

Exclusion Criteria: due to 

unscheduled 

perioperative 

antimicrobial therapy

the addition of 

metronidazole for surgery 

of the jejunum, ileum, 

colon, and rectum-anus.

Standard preventive 

measures: NR

including gastrectomy 

(n=8), gastric banding 

(n=35) and other gastric 

(n=21) 

deep surgical sepsis: 

1dose: 1/24 (4%) 

3dose: 4/40 (10%); 

p=0.41

Becker

1991 35

(ES)

RCT

1, 3, 4, 

5, 6, 7, 

8, 9

To study in a 

prospective, 

double-blind 

randomized, 

fashion, the 

efficacy of a 

short 

perioperative 

course versus 

an extended 

postoperative 

course of 

intravenous 

antimicrobials 

in patients 

Number of patients: 

n=40

Patient Characteristics: 

Patient characteristics 

were similar between 

groups except:

Entry into bowel lumen:

 5day: 9/18 (50%)

 12h: 6/22 (27%) but 

major contamination 

was not statistically 

significantly different.

Procedures: Colectomy, 

mucosal protectomy, 

and ileal pouch-anal 

Intervention group: n=18

After 12h postop, patients 

received 1g cefoxitin 

intravenously every 6h for 

5 days beginning 6h after 

fixed postop dose

Timing of intervention: 

postop

Duration of intervention: 5 

days 

Device/agent: 1g cefoxitin 

intravenously.

Control group: n=22

After 12h postop, patients 

received placebo 

SSI 

no wound or intra-abdominal 

infections in either group 

at 1yr follow up: 

5 day: 0/22 vs. 

12h: 0/18.

Length of stay: 

No difference: (mean±SD) 

 5 day: 8.7±0.4 days

 12h: 8.4±0.2 days.

Definitions: 

Wound was 

considered 

uninfected if it 

was healing 

without evidence 

of erythema or 

discharge.

Infected: if purulent 

drainage was 

present, 

regardless of 

culture results or 

if nonpu8rulent 

material 
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and should not be construed to represent any agency determination or policy. 74

Author

Year

(Data 

Extractor)

Study 

Design

Quality 

Score

Study Objective Population and Setting Intervention Results Comments

undergoing 

colectomy, 

mucosal 

protectomy and 

ileal pouch-anal

anastomosis.

anastomosis.

Indications: chronic

ulcerative colitis, 

familial polyposis, or 

Gardner’s syndrome

Setting: 1 university 

hospital

Location: USA

Dates: NR (9months)

Inclusion Criteria: 

Patients with chronic 

ulcerative colitis, 

familial polyposis or 

Gardner’s syndrome 

who required 

colectomy and who 

were candidates for 

mucosal protectomy 

with ileal pouch-anal 

anastomosis.

Exclusion Criteria: Allergy 

to penicillin or 

cephalosporin; 

antimicrobial use 

within 1 week before 

operation, mechanical 

bowel obstruction or 

any other functional 

or anatomic reason 

precluding mechanical 

bowel prep; or the 

presence of an existing 

ileostomy or 

colostomy.

(dextrose in water) 

intravenously every 6h for 

5 days beginning 6h after 

fixed postop dose

Standard preventive 

measures:

1) clear liquid diet for 4 days 

before surgery; 2) 

mechanical bowel prep 

consisting of 300ml of 

oral magnesium citrate 

and 2 tap water enemas 

administered on preop 

day 2 and 300ml of oral 

magnesium citrate and 

tap water enemas until 

clear administered on 

preop day 1; 3) oral 

antimicrobial preparation 

consisting of 1g neomycin 

and 1g erythromycin base 

by mouth at 1:00pm, 

2:00pm,. And 11:00pm on 

preop day 1; 4) 2g 

cefoxitin administered 

intravenously during a 20 

min period immediately 

before surgery with 

additional 2g iv doses of 

cefoxitin given at 6h and 

12h after the initial dose.

Also, rectum was irrigated 

with PI solution via 

transanal rectal catheter. 

contained 

pathogenic 

bacteria.

Deep infection – if 

infection 

extended below 

fascia

Moderate – when 

subcutaneous 

tissues were 

involved.

Possibly infected –

evidence of 

induration and 

inflammatory 

changes of the 

skin but without 

purulent 

discharge

Other notes: None

Follow-up: 8 weeks 

post discharge 

when loop 

ileostomy was 

closed. Patients 

were then 

followed for 12 

months after 

closure.
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and should not be construed to represent any agency determination or policy. 75

Author

Year

(Data 

Extractor)

Study 

Design

Quality 

Score

Study Objective Population and Setting Intervention Results Comments

Garotta

1991 14

(ES)

RCT

1, 2

To evaluate the 

relative 

effectiveness of 

two 

cephalosporin 

antimicrobials, 

ceftizoxime vs. 

cefuroxime, in 

preventing the 

development of 

complicating 

infections in 

patients 

submitted to 

elective surgery 

in orthopedic 

departments.

Number of patients: 

N=614

Patient Characteristics: 

both arms were 

homogeneous for 

several characteristics 

such as patients’ age, 

sex, length and type of 

operation and postop 

procedures.

Procedures: Hip or knee 

replacement or 

fracture fixation

Setting: 30 hospitals

Location: Italy

Dates: NR

Inclusion Criteria: 

Patients >18 years, 

undergoing orthopedic 

surgeries such as hip 

or knee replacement 

and fractures fixed by 

foreign bodies.

Exclusion Criteria: 

Evidence of acute 

infection; 

antimicrobial 

treatment within 48

hours prior to 

operation or use of 

local antimicrobials; 

and open fractures

Intervention group: n=301

1dose: given 2g ceftizoxime 

intravenously 30 minutes 

before the operation

Timing of intervention: pre 

and postop

Duration of intervention: 

preop and up to 12h after 

operation

Device/agent: ceftizoxime

Control group: n=313

2dose: given 2g ceftizoxime 

intravenously 30 minutes 

before the operation and 

12h postop.

Standard preventive 

measures: NR

SSI: 

1dose: 2/301 (0.66%)

Multi: 3/313 (0.96%)

Definitions : 

Wound infection: 

purulent 

exudation with 

positive microbio 

culture.

Perioperative care: 

NR 

Other notes: none

Follow-up: 1 year
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and should not be construed to represent any agency determination or policy. 76

Author

Year

(Data 

Extractor)

Study 

Design

Quality 

Score

Study Objective Population and Setting Intervention Results Comments

Buckley 

1990 9

(ES)

RCT

1, 3, 4, 

5

To determine

whether or not 

cefazolin 

decreased early 

postoperative 

wound 

infection rates, 

and whether 

single-dose 

cefazolin was as 

effective as 

multiple dose 

(4 doses) 

cefazolin in 

preventing 

early 

postoperative 

wound 

infections 

resulting from 

hip surgery. 

They also 

compared 

single and 3 

doses to no 

AMP.

Number of patients: 

N=312

Patient Characteristics: 

All groups similar in 

age (P=0.75) and sex 

distribution (P=0.86)

·Age: mean±SD (range), 

year

 Intervention1: 

76.3±14.9 (18-100)

 Intervention2: 

77.1±12.1 (33-94)

 Control: 76.1±13.4 (29-

96)

·Gender m/f

 Intervention1: 32/89

 Intervention2: 22/61

 Control: 3/75

·Obesity NR

·Comorbidities NR

Procedures: 

Prosthetic Hip: 

 Intervention1: 56 

(51.9%)

 Intervention2: 32 

(38.6%)

 Control: 33 (27.3%)

Multiple Pins: (21 Total)

 Intervention1: 8 (7.4%)

 Intervention2: 5 (6.0%)

 Control: 8 (6.6%)

Compression Screw: (170 

Total)

 Intervention1: 57 

(52.8%)

 Intervention2: 46 

Intervention1 group: n= 108

AMP Four doses: 2g 

Cefazolin administered 

intravenously when 

anesthesia was induced, 

then 1g cefazolin every 6 

hours intravenously for 

three doses making a 

total of four doses of 

cefazolin

Intervention2 group: n= 83

AMP single dose: 2g 

Cefazolin administered 

intravenously when 

anesthesia was induced, 

then saline every 6 hours 

intravenously for three 

doses.

Timing of intervention: Pre, 

intra and postoperatively

Duration of intervention: 

From induction of 

anesthesia to 24 hours 

postop.

Device/agent: Cefazolin

Monitoring intervention: 

Blood cefazolin levels 

were examined 

intraoperatively for the 

first 14 patients and 

found to be 10 times the 

minimal inhibitory 

concentration

Control group: n= 121

No AMP: Saline administered 

intravenously for four 

SSI: (Follow up 6 weeks)

Wound infection

 Intervention1+2: 

4/191(2.0%)

 Control: 4/121 (3.7%)

 P=0.46

When not combined

 Intervention1: 2 (1.6%)

 Intervention2: 2 (2.4%)

 Control: 4 (3.7%)

All superficial except for 1 

control group deep 

infection in a 96-year-old 

woman which was 

implicated in her death at 

14 days postop.

All other infected patients 

were discharged from the 

study after 6 weeks with 

healed wounds.

Wound infection by 

Operation Type

Prosthetic Hip: 

 Intervention1+2: 2 (1.0%)

 Control: 2 (1.9%)

Pins + Compression Screws

 Intervention1+2: 2 (1.0%)

 Control: 2 (1.9%)

P=0.72

Average age of infected 

patients: 84.2 years (8 

years older than noninfected patients though 

not statistically significant 

(p=0.11)

Definitions: 

Definite Wound 

infection: if there 

was a purulent 

discharge, 

whether or not 

organisms were 

cultured.

Possible wound 

infection: 

inflammation 

without discharge 

and wounds that 

drained culturepositive serous 

fluid. The patient 

was followed up 

until the wound 

healed or drained 

pus.

Perioperative care: 

NR 

Other notes: Due to 

low infection 

rates, groups 

Intervention1 & 

Intervention2 

were combined to 

increase the 

power.

Statistics:

Sample size of 120 

per arm selected 

to detect 

difference in 

infection rate of 
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and should not be construed to represent any agency determination or policy. 77

Author

Year

(Data 

Extractor)

Study 

Design

Quality 

Score

Study Objective Population and Setting Intervention Results Comments

(55.4%)

 Control: 67 (55.4%)

Type of surgery was not 

evenly distributed 

between groups: 

(P=0.05) but this 

variable did not turn 

out to be a 

confounder

Drain Used (179 Total

 Intervention1: 67 

(62.0%)

 Intervention2: 49 

(59.0%)

 Control: 63 (52.1%)

 P=0.85, χ2= 5.95, df = 2

Indications: Fractured hip 

(interochanteric or

subcapital)

Setting: 1 hospital 

Location: Canada

Dates: December 1, 1985 

– December1 , 1988

Inclusion Criteria: All 

adults with an 

interochanteric or 

subcapital hip 

fracture.

Exclusion Criteria: 

Cephalosporin allergy, 

pathologic fracture 

due to tumor, 

previous surgery on 

the fractured hip, 

treatment with an 

antimicrobial other 

doses.

Standard preventive 

measures: NR

Non-standard preventive 

measures

Surgery: Fractured hip was 

treated with either hip 

pinning (with compression 

screw or multiple pins) or a 

hip prosthesis implant.

Drain: At surgeon’s 

discretion, a drain was 

placed for subcutaneous 

tissue drainage.

Other infections: NR

Topic-specific outcomes: NR

Antimicrobial resistance:

All infections were S. aureus 

sensitive to cephalothin. 

No gram negatives were 

isolated.

Reoperations: NR

Length of stay: NR, but no 

patients’ length of stay 

was lengthened by a 

drug-related complication

Mortality:

Total: 15 deaths (4.8%)

 Intervention1: 3 (2.8%)

 Intervention2: 4 (4.8%)

 Control: 8 (6.6%)

Cause of all deaths was 

cardiopulmonary except 

for the patient described 

above who died of multiorgan system failure (the 

deep wound infection 

possibly contributed)

All patients who died were in 

their ninth or tenth 

decade of life.

Adverse events: No 

anaphylactic reactions, 

allergies or renal toxicity 

related to cefazolin 

administration. Also, no 

cefazolin cross-reactions 

with patients who 

claimed a history of 

“penicillin rashes”

9% with 

probability of type 

a error of <0.10 

and type β error 

of <0.20.

Follow-up: Complete 

follow-up at 6 

weeks post-op.
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and should not be construed to represent any agency determination or policy. 78

Author

Year

(Data 

Extractor)

Study 

Design

Quality 

Score

Study Objective Population and Setting Intervention Results Comments

than cefazolin, or a 

preoperative course in 

hospital longer than 7 

days.

Hall

1989 36

(ES)

RCT

1, 2, 7, 

8 

To evaluate the 

efficacy of 

moxalactam 

given as a single 

dose or as a 48-

hour regimen 

for a range of 

potentially 

contaminated 

abdominal 

operations.

Number of patients: 

N=1027

Patient Characteristics: 

NR

Procedures: 

Appendectomy, 

cholecystectomy, bile 

duct surgery, elective 

colorectal, emergency 

colorectal, 

gastroduodenal, and 

small-bowel surgery.

Setting: 2 centers (both 

general hospitals)

Location: Australia

Dates: NR 

Inclusion Criteria: 

consecutive patients 

>14 years of age who 

were undergoing 

potentially 

contaminated 

abdominal surgery at 

one of 2 hospitals.

Exclusion Criteria: 

Postop antimicrobial

Intervention group: n=519 

patients given 1 1g 

moxalactam 

intravenously at induction 

of anesthesia

Timing of intervention: pre 

and post-operative

Duration of intervention: 1 

dose or 48h postop.

Device/agent: 1g 

moxalactam 

intravenously

Control group: n=508 

patients who received 1g 

of moxalactam 

intravenously at induction 

of anesthesia followed by 

1g of moxalactam 

intravenously every 6h for 

a further 7 doses. 

Equaling a total of 8g in 

48h/

Standard preventive 

measures: Patients were 

given 10mg of Vitamin K 

intramuscularly prior to 

SSI 

• Total colorectal: 

Total: 22/245 (9.0%)

 Single: 12/119(10.1%)

 48h: 10/126(7.9%); 

 p=0.56

• Elective colorectal

procedures (n=207)

 Single: 11/102(10.7%) 

 48h: 6/105(5.6%); 

 p=0.19

• Emergency Colorectal (no 

bowel prep in emergency 

cases): 

 Single: 1/17(5.8%) 

 48h: 4/21(20.0%); 

 p=0.26

Definitions:

Wound Infection: 

purulent wound 

discharge or a 

serous wound 

discharge with 

culture of 

pathogenic 

organisms.

Major wound 

infection: if it 

resulted in an 

extension of the 

hospital stay or 

required dressings 

at home for more 

than 7 days 

Minor wound 

infection: if 

neither of these 

features occurred.

Peritoneal infection: 

if pus or 

peritoneal fluid 

containing 

pathogenic 
Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminated by the Centers for Disease Control and Prevention 

and should not be construed to represent any agency determination or policy. 79

Author

Year

(Data 

Extractor)

Study 

Design

Quality 

Score

Study Objective Population and Setting Intervention Results Comments

for residual infection; 

antimicrobial 

administration within 

48h prior to operation; 

viscus not opened at 

operation; failure to 

give informed consent 

failure to give initial 

dose of moxalactam 

history of 

cephalosporin 

sensitivity or penicillin 

anaphylaxis; 

established renal or 

liver failure; reaction 

to initial dose of 

moxalactam.

operation due to reports 

of coagulopathy 

associated with 

moxalactam.

Skin prep – Povidone Iodine 

& no local antimicrobial 

or antiseptic prep

Drain tubes – were passed 

through a separate 

incision.

Bowel prep – all patients 

received a two-day 

mechanical bowel prep 

(no oral antimicrobials

were administered)

organisms were 

found at the 

operations, if 

there was 

spontaneous 

discharge or 

needle aspiration 

of pus from the 

peritoneal cavity 

or if there was a 

collection of pus 

present at 

autopsy.

Other notes: Study 

was sufficiently 

powered to 

detect a 

difference in 

wound infection 

rates.

Follow-up: 5

th

postoperative 

week.

Ritter

1989 16

(ES)

RCT

1, 7, 8

To identify the 

relationship 

between the 

duration of 

prophylaxis and 

the incidence of 

latent wound 

infectionNumber of patients: 

N=196

Patient Characteristics

Reported but not 

significant intergroup 

differences.

Procedures: primary 

unilateral or bilateral 

TKA or THA

Indications: NR

Setting: 1 university 

Hospital

Location: USA

Intervention group: n=98

2dose: Two intraoperative 

doses of cefuroxime 

(1500mg & 750mg)

Timing of intervention: intra 

and postop

Duration of intervention: 

intraop up to 24h postop

Device/agent: cefuroxime

Control group: n=98

5dose: Two intraoperative 

doses of cefuroxime 

(1500mg & 750mg) 

SSI 

In the second smaller study 

(N=196), in unilateral or 

bilateral THA or TKA 

patients no infections 

(including deep wound 

infections) were reported 

in either group

2dose: 0/98

5dose: 0/98

Definitions: NR

Perioperative care : 

NR 

Other notes: None

Follow-up: 12month 

follow up
Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminated by the Centers for Disease Control and Prevention 

and should not be construed to represent any agency determination or policy. 80

Author

Year

(Data 

Extractor)

Study 

Design

Quality 

Score

Study Objective Population and Setting Intervention Results Comments

Dates: NR

Inclusion Criteria: 

Patients undergoing 

primary unilateral or 

bilateral THA or TKA

Exclusion Criteria: NR

followed by 24h of postop 

cefuroxime (750mg every 

8 hours)

Standard preventive 

measures: NR

Moesgaard

1989 40

(ES)

RCT

1, 2, 7, 

8

To investigate 

the relationship 

between 

preoperative 

cell-mediated 

immunity (CMI) 

and 

postoperative 

infection and 

whether 

patients with 

impaired CMI 

would benefit 

from prolonged 

antimicrobial 

prophylaxis.

Number of patients: 

N=428

Patient Characteristics: 

groups were well 

matched and equally 

distributed.

Procedures: elective 

colorectal surgery

Setting: 1 university 

hospital

Location: Denmark

Dates: 1982-1986

Inclusion Criteria: all 

patients undergoing 

elective colorectal 

surgery.

Exclusion Criteria: Those 

admitted for rectal 

amputation, known 

allergy to the 

antimicrobials used, 

pregnancy, age<15 

years, and any 

antimicrobial therapy 

5 days prior to 

surgery.

Intervention group: n=209

Short term prophylaxis: 

gentamicin 80mg iv + 

metronidazole 500mg iv 

at the start of the 

operation followed by 

repetition of these doses 

6 hours later.

Timing of intervention: pre 

and postop

Duration of intervention: 6h 

or 2 days

Device/agent: gentamicin 

80mg iv + metronidazole 

500mg iv

Control group: n=219

Long term prophylaxis: 

gentamicin 80mg iv + 

metronidazole 500mg iv 

at the start of the 

operation followed by 

repetition of these doses 

every 8hours for 2 days.

Standard preventive 

measures: Bowel prep NR

SSI 

Total: 45/428 (11%); 

6hr: 22/209(11%) 

2day: 23/219(11%)

p=0.99 

Intra-abdominal abscess: 

Total: 14/428 (3%)

6hr: 6/209 (3%) 

2day: 8/219 (4%)

p=0.65 

Definitions: 

Wound infection: 

presence of pus, 

either discharging 

spontaneously or 

requiring 

drainage.

Intra-abdominal 

abscess: verified 

by surgical 

drainage or 

ultrasound guided 

aspiration of pus.

Other notes: none

Follow-up: 30 days
Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminated by the Centers for Disease Control and Prevention 

and should not be construed to represent any agency determination or policy. 81

Author

Year

(Data 

Extractor)

Study 

Design

Quality 

Score

Study Objective Population and Setting Intervention Results Comments

Grundman

n

1987 19

(ES)

RCT

1

To define 

whether a 

single 

preoperative 

dose of 

mezlocillin/ 

metronidazole 

is sufficient in 

colon surgery 

or whether 

under certain 

circumstances 

(long operation 

time, 

insufficient 

bowel prep, 

high blood loss) 

a multiple 

administration 

of 

antimicrobials 

is more 

justified.

Number of patients: 

N=154

Patient Characteristics:

While statistical 

significance is not 

indicated, the 1 dose 

group had a higher 

percentage of high risk 

patients including 

patients with age>58 

years, operation time 

>2.5h, Body 

weight>69kg,

insufficient bowel 

lavage and blood 

transfusions.

Procedures: elective 

colorectal surgery

Setting: 1 university 

hospital

Location: Germany

Dates: NR

Inclusion Criteria: 

patients undergoing 

colon surgery.

Exclusion Criteria: NR

Intervention group: n=25

Patients who received a 

single dose of 

metronidazole and 

mezlocillin (5g/0.5g) prior 

to the operation

Timing of intervention: pre 

and postoperative.

Duration of intervention: up 

to 6h postop

Device/agent: 

metronidazole and 

mezlocillin (5g/0.5g)

Monitoring intervention: 

pre, intra and postop.

Control group: n=28

Patients received 5g 

metronidazole/ 0.5g 

mezlocillin prior to the 

operation, a second dose 

90 minutes post-skin 

incision and 6 hours after 

the second dose.

Standard preventive 

measures: 

Bowel Prep: Orthograde 

SSI 

SSI:

1dose: 4/77(5.2%) 

3dose: 4/77(5.2%)

Intra-abdominal abscess

1dose: 2/77(2.6%) 

2doses: 1/77(1.3%);

p=0.57 

Peritonitis 

1dose: 2/77(2.6%)

3doses: 2/77(2.6%); 

Definitions: NR

Perioperative care: 

NR 

Other notes: None

Follow-up: NR
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and should not be construed to represent any agency determination or policy. 82

Author

Year

(Data 

Extractor)

Study 

Design

Quality 

Score

Study Objective Population and Setting Intervention Results Comments

bowel prep with no 

antimicrobial ingredients. 

And no preop oral 

antimicrobial for the 

purpose of bowel prep.

Juul

1987 37

(ES)

RCT

1, 2, 7, 

8

To evaluate the 

prophylactic 

effect of a 

single dose 

versus multiple 

doses of 

systemic 

ampicillin and 

metronidazole 

in elective 

colorectal 

surgery.

Number of patients: 

N=294

Patient Characteristics: 

No significant 

differences between 

groups.

Procedures: Elective 

colorectal surgery

Setting: 1 university 

hospital

Location: Denmark

Dates: October 1983-

April 1986

Inclusion Criteria: 

Patients 18y or older, 

undergoing elective 

colorectal surgery 

during the study 

dates. 

Exclusion Criteria: 

Patients receiving 

antimicrobials in the 

preoperative period or 

those with a history of 

hypersensitivity to 

ampicillin or 

Intervention group: 

Patients received 1.5g 

metronidazole and 3g 

ampicillin intravenously at 

induction of anesthesia

Timing of intervention: Pre 

and postoperative

Duration of intervention: 1 

dose or 3 postop days

Device/agent: 

metronidazole & 

ampicillin

Control group: 

Patients received 1.5g 

metronidazole and 3g 

ampicillin intravenously at 

induction of anesthesia 

followed by 

Metronidazole 0.5g and 

ampicillin 1g each 3 times 

during the second and 

third postoperative days.

Standard preventive 

measures : 

Bowel prep: bowel was 

emptied either 

SSI 

Deep wound infections: 

 Total: 17/294 (5.8%); 

 Single Dose: 9/149 (6%) 

 Multiple: 8/145 (6%) 

Intra-abdominal abscess: 

 Total: 3/294 (1.0%)

 Single: 1/149 (1%) 

 Multiple 2/145 (1%) 

Topic Specific outcomes:

No difference in bacterial 

isolates and no report of 

antimicrobial resistance

Definitions : 

Deep wound 

infection: 

accumulation of 

pus either with 

spontaneous 

discharge or 

requiring surgical 

drainage.

Wound dehiscence: 

subcutaneous and 

fascial 

breakdown, but 

without pus 

accumulation.

Intra-Abdominal 

Abscessintraperitoneal or 

pelvic collection 

of pus with 

spontaneous 

discharge or 

which required 

surgical drainage.

Perioperative care: 
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and should not be construed to represent any agency determination or policy. 83

Author

Year

(Data 

Extractor)

Study 

Design

Quality 

Score

Study Objective Population and Setting Intervention Results Comments

metronidazole. Also, 

patients not receiving 

full does or the bowel 

note being opened 

during surgery.

conventionally or by 

whole gut irrigation.

NR 

Other notes: None

Follow-up : 30 days

Mendel

1987 38

(ES)

RCT

1

To assess the 

prophylactic 

value of a oneshot regimen of 

antimicrobials.

Number of patients: 

N=100

Patient Characteristics: 

NR

Procedures: elective 

excision of colorectal 

carcinoma or 

diverticulitis.

Setting: 1 Hospital

Location: Germany

Dates: NR

Inclusion Criteria: 

Patients requiring 

excision of colorectal 

carcinoma or 

diverticulitis

Exclusion Criteria: 

Patients with a 

colostomy or who had 

received other 

antimicrobials within 

72h of operation.

Intervention group: n=54

Patients receiving a “single 

shot” of 5g mezlocillin 

and 500mg metronidazole 

Timing of intervention: pre 

and postop

Duration of intervention: 

1dose or 3 days postop

Device/agent: mezlocillin5g 

and metronidazole 500mg

Control group: n=46 

patients receiving 9 doses 

of 5g mezlocillin and 

500mg metronidazole (a 3 

day regimen)

Standard preventive 

measures: 

Bowel prep: all patients 

underwent standard 

preop bowel prep (from 4 

days preop!)

SSI 

Total: 3/100 (3.0%);

Single dose: 2/54 (3.7%) 

3day: 1/46 (2.1%); 

p=0.66 

Definitions: NR

Perioperative care: 

NR

Other notes: none

Follow-up: NR

Funding source 

conflict of 

interest: NR
Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminated by the Centers for Disease Control and Prevention 

and should not be construed to represent any agency determination or policy. 84

Author

Year

(Data 

Extractor)

Study 

Design

Quality 

Score

Study Objective Population and Setting Intervention Results Comments

Gatell

1987 13

(ES)

RCT

1, 3, 4, 

5, 7, 8, 

10

To compare the 

use of five 

doses of 

cefamandole 

with a single 

preoperative 

dose for 

preventing 

wound 

infection s after 

so-called clean 

orthopedic 

operations in 

which there 

was 

implantation of 

a metal device.

Number of patients: 

N=717

Patient Characteristics: 

Characteristics were 

similar between 

groups.

Procedures: Clean 

orthopedic operations 

in which there was a 

metal device 

implanted.

Setting: 1 university 

hospital

Location: Spain

Dates: NR

Inclusion Criteria: All 

adults scheduled for 

an orthopedic surgical 

procedures that 

required insertion of a 

metal device for 

fixation of bone.

Exclusion Criteria: total 

joint replacement, a 

known allergy to 

penicillin or 

cephalosporins, and 

those who had 

immunosuppressive 

treatment, those who 

had an open fracture 

or a previous infection 

of the operative field, 

and those receiving 

any antimicrobials.

Intervention group: n=382

1dose: 1 preoperative 

intravenous dose of 

cefamandole (2g) given 1⁄2 

hour before starting the 

operation. This was 

followed by This was 

followed by 4 doses of 

placebo following the 

control drug schedule

Timing of intervention

Duration of intervention

Device/agent: cefamandole

5dose: patients receiving a 

2g cefamandole dose 

intravenously 30 min preop

and 2g intravenously at 2h 

after the start of surgery. 

This was followed by 1 gram 

intravenously or 

intramuscularly at 8, 14, & 

24 hours thereafter.

Control group: n=335

Standard preventive 

measures: 

Skin prep: skin was shaved 

with disposable razor & 

cleaned with antiseptic 

soap just before entering 

OR. Alcoholic PI was 

applied to the operative 

site and allowed to 

remain for 2min.

Patients in both groups were 

hospitalized for 

approximately 5 days 

SSI 

1dose: 20/382

5dose: 3/335

p=0.004 

Hemiarthroplasties: 

1dose: 5/76 (6.5%) 

5dose: 0/74(0%); 

p=0.03 

All other procedures 

combined: 

1dose: 15/306 (5%)

5dose: 3/261(1%);

p=0.006. 

Antimicrobial Resistance

31 organisms isolated from 

23 wound infections: 9 

Staphylococcus aureus, 4 

S. epidermis and 4 E. coli 

all sensitive to the AMP. 

In addition, 4 

Pseudomonas aeruginosa, 

and 3 Streptococcus 

faecalis all resistant to the 

AMP and 7 strains of 

other gram negative 

bacilli, 2 of them resistant 

to the AMP.

Mortality

There were 30 deaths (4%); 1 

patient had an 

uncontrolled wound 

infection but the cause of 

Definitions:

Wound infection: 

diagnosed when 

the wound 

drained pus

spontaneously or 

was inflamed to 

the point that it 

had to be opened 

by the surgeon 

and then drained 

purulent material. 

A hematoma or 

wound draining 

serous material 

was considered to 

be infected only 

when it cultured 

positive.

Perioperative care: 

NR 

Other notes: None

Follow-up: Minimum 

12months (range 

12-24 months) or 

if patients had an 

infection, until 

metal device was 

removed.
Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminated by the Centers for Disease Control and Prevention 

and should not be construed to represent any agency determination or policy. 85

Author

Year

(Data 

Extractor)

Study 

Design

Quality 

Score

Study Objective Population and Setting Intervention Results Comments

before surgery. death was a stroke.

Oostvogel

1987 11

(ES)

RCT

1, 2, 3, 

5, 6, 7

To compare a 

short term 

antimicrobial

regimen (1 

preop & 2 

postop doses) 

with a singledose regimen 

of intravenous 

antimicrobials. 

Number of patients 

N=169

Patient Characteristics: 

the two groups did not 

differ significantly. 

Procedures: vascular 

surgery

Setting: 1 general 

hospital

Location: the 

Netherlands

Dates: November 1983 –

January 1985

Inclusion Criteria: All 

patients admitted for 

emergency or elective 

surgery during the 

study dates if the 

operation was 

classified as “cleancontaminated” or 

“contaminated” 

according to the NRC 

criteria; or when a 

vascular operation was 

planned (“Clean” 

operation)

Exclusion Criteria: 

patients with multiple 

trauma or mechanical 

intestinal obstruction 

or who were already 

Intervention group: n=80 

(1dose)

Received 2 million U 

benzylpenicillin i.v. + 

120mg tobramycin i.m. 

1hr preop

Timing of intervention: pre 

and postop

Duration of intervention: 1 

dose or 12h postop.

Device/agent: 

benzylpenicillin + 

tobramycin

Control group: n=89 (3dose)

Received 2 million U 

benzylpenicillin i.v. + 

120mg tobramycin i.m. 

1hr preop plus 1million U 

benzylpenicillin i.v. + 

80mg tobramycin i.m. at 

6h & 12h postop.

Standard preventive 

measures: NR

SSI 

Vascular surgery 

Single Dose: 3/80 (2.3%)

3 Dose: 2/89 (3.8%)

p>0.5

Definitions:

Wound infection: 

presence of pus 

discharging 

spontaneously or 

requiring drainage

Perioperative care: 

NR 

Other notes: None

Follow-up: 1 month
Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminated by the Centers for Disease Control and Prevention 

and should not be construed to represent any agency determination or policy. 86

Author

Year

(Data 

Extractor)

Study 

Design

Quality 

Score

Study Objective Population and Setting Intervention Results Comments

receiving 

antimicrobials for 

reasons other than 

prevention of wound 

infections, or who had 

severely impaired 

renal function or 

known 

hypersensitivity to one 

of the study 

antimicrobials. Also 

excluded were all 

patients found at 

operation to have 

bacterial peritonitis. 

Also perineal wounds.

Wenzel

1985 41

(ES)

RCT

1, 2, 7, 

8, 9

To investigate 

and compare 

the extent of 

the reduction in 

post-operative 

infection risk in 

patients 

undergoing 

elective colonic 

surgery using 

two prophylaxis 

regimens. 1) A 

“one shot” 

method versus 

2) pre-op 

combined with 

postop 

antimicrobial 

infusions for up 

Number of patients: 

N=60

Patient Characteristics

No significant differences 

in patient parameters.

Procedures: Surgery of 

the colon and rectum

Setting: 1 hospital.

Location: Germany

Dates: NR

Inclusion Criteria: 

Patients who had to 

undergo abdominal 

surgery involving 

opening of the colon.

Exclusion Criteria: 

Patients who were to 

have appendectomies, 

those known 

Intervention group: n=30

1dose: 1 dose of 100mg 

ornidazole and 80mg 

gentamicin administered 

intravenously 45min 

before operation with 

pre-medication.

Timing of intervention: pre 

and postop

Duration of intervention: up 

to 48h postop

Device/agent: ornidazole 

and gentamicin

Control group n=30

48h: 1 dose of 100mg 

ornidazole and 80mg 

gentamicin administered 

intravenously 45min 

before operation with 

SSI 

Total SSI

1dose: 6/30 (20%) 

48hDose: 10/30 (33.3%)

p=0.25

Intra-abdominal abscess:

No difference: 

1dose: 2/30 (7%) 

48hdose: 2/30 (7%); 

Peritonitis :no difference: 

1dose: 1/30 (3%)

48hdose: 3/30 (10%); 

p=0.32

Superficial SSI:

1dose: 3/30 

48h Dose: 5/30 

Definitions: 

Wound infection: 

edematous

and/or red wound 

with a purulent 

secretion.

Perioperative care: 

NR 

Other notes: 

Complication 

rates were high 

for both groups.

Follow-up: NR
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and should not be construed to represent any agency determination or policy. 87

Author

Year

(Data 

Extractor)

Study 

Design

Quality 

Score

Study Objective Population and Setting Intervention Results Comments

to 48h. hypersensitivity to 

ornidazole or 

aminoglycosides, 

those who received 

antimicrobial

treatment less than 5d 

before the operation 

and those with preoperative fecal 

contamination.

pre-medication. Followed 

by 3 further doses of 

500mg ornidazole at 12h 

intervals and 3 doses of 

80mg gentamicin at 8h 

intervals.

Standard preventive 

measures: patients with 

non-stenosing tumors 

were fed a full calorie diet 

and were fed orally or 

enterally up to the day 

preceding the operation. 

Patients with stenosing 

tumors were given 

parenteral feeding 

additionally or exclusively.

Bowel Prep: NR

Carr

1984 18

(ES)

RCT

1, 3

To establish 

whether 

additional 

doses of 

intravenous 

metronidazole 

for up to 24h 

after elective 

colorectal 

surgery would 

reduce the 

wound 

infection rate 

further.

Number of patients: 

N=90

Patient Characteristics:

the four groups of 

patients were well 

matched.

Procedures: Intestinal 

anastomoses.

Indications: NR

Setting: 1 teaching 

hospital

Location: United 

Kingdom

Dates: April 1980 –

February 1982

Inclusion Criteria: 

Patients who 

underwent elective 

Intervention group: n=22

Patients receiving only a preoperative bolus of 500ml 

intravenous 

metronidazole.

Timing of intervention: pre 

and postop

Duration of intervention: up 

to 24h

Device/agent: 

metronidazole

Control group: n=68

Patients receiving 

postoperative 

intravenous 500mg 

injections of 

metronidazole every 8h 

up to 24h postop.

SSI:

all durations ≤24h combined 

suggest no difference 

between groups for 

Total Wounds

1 dose: 8/25 (32%)

2-4doses: 18/81 (22.2%)

Abdominal wounds: 

Total 18/90(20%): 

1dose: 7/22 (31%) 

2-4doses: 11/68(16%)

p=0.12 

Perineal wounds: 

1/3 (33.3%) vs.

7/13 (53.8%); 

p=0.53, at 6 week follow up.

Definitions: 

Infected wound: one 

from which there 

was a purulent 

discharge from 

the main suture 

line even if culture 

was negative.

Perioperative care: 

NR 

Other notes: None

Follow-up: 6 weeks 

post op.
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and should not be construed to represent any agency determination or policy. 88

Author

Year

(Data 

Extractor)

Study 

Design

Quality 

Score

Study Objective Population and Setting Intervention Results Comments

colorectal surgery 

during the study 

dates.

Exclusion Criteria: 

Patients who received 

antimicrobials in the 

preceding 2 weeks and 

patients with 

inflammatory bowel 

disease who had 

abscesses, fistulas or 

toxic dilatation of the 

colon.

Standard preventive 

measures: 

Bowel prep consisted of 

magnesium sulphate 2g 

TDS for 3 days before the 

operation and a standard 

mechanical method of 

bowel prep containing no 

antimicrobials.

Hasselgren

1984 29

(ES)

RCT

1, 3, 4, 

5, 6, 7, 

8

To evaluate the 

effects of a 1 

day versus a 3 

day course of

cefuroxime on 

infection rates 

in peripheral 

vascular 

surgery.

Number of patients: 

N=121

Patient Characteristics: 

relative distribution of 

risk factors did not 

differ significantly 

between the study 

groups.

Procedures: vascular 

surgery

Setting: 1 university 

hospital

Location: Sweden

Dates: January 1981 –

June 1983

Inclusion Criteria: 

Patients scheduled for 

vascular 

reconstructive surgery 

of the lower limbs and 

patients undergoing 

acute femoral 

Intervention group: 

1day: patients administered 

3 doses of cefuroxime 

1.5g intravenously 

beginning 1 hour before 

surgery and then every 8 

hours ( up to 16h postop)

Timing of intervention: pre 

and postop

Duration of intervention: 1 

or 3 days postop

Device/agent: 1.5g 

cefuroxime iv

Control group: 

3day: patients administered 

9 doses of cefuroxime 

1.5g intravenously 

beginning 1 hour before 

surgery and then every 8 

hours ( up to 64h postop)

Standard preventive 

measures: 

SSI 

1day: 2/52 (3.8%) 

3day: 3/69 (4.3%)

 p=0.89 

Definitions: 

Wound infection: 

accumulation of 

pus that drained 

spontaneously or 

after 

debridement.

Graft infection: 

defined as any 

persistent wound 

infection 

communicating 

with graft 

material.

Perioperative care: 

NR 

Other notes: NR

Follow-up: 30 day 

follow up
Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminated by the Centers for Disease Control and Prevention 

and should not be construed to represent any agency determination or policy. 89

Author

Year

(Data 

Extractor)

Study 

Design

Quality 

Score

Study Objective Population and Setting Intervention Results Comments

embolectomy or 

thrombectomy.

Exclusion Criteria: 

Patients scheduled for 

an aortic bifurcation 

graft; patients having 

received 

antimicrobials within 1 

week prior to surgery; 

patients with cellulitis 

or wet gangrene on 

lower extremities; and 

patients with a history 

or penicillin or 

cephalosporin allergy.

Skin prep: wash with 

chlorhexidine soap 3 

times on day prior to 

surgery. 

Hair removal: shaving 

immediately prior to 

surgery.

Hemsell

1984 23

(ES)

RCT

1, 2, 4, 

5, 6, 7, 

8

To compare a 

preoperative 

dose with three 

perioperative 

doses of 

cefoxitin given 

to 

premenopausal 

women 

scheduled for 

vaginal 

hysterectomy. 

Number of patients: 

N=112

Patient Characteristics

Clinical and surgical 

variables were 

statistically similar 

between groups.

Procedures: vaginal 

hysterectomy

Setting: 1 university 

hospital

Location: USA

Dates: February –

December 1982

Inclusion Criteria: 

premenopausal 

women undergoing 

vaginal hysterectomy

Exclusion Criteria: 

known allergy to 

Intervention group: n=58

1 dose: patients received 1 

preoperative dose of 2g 

cefoxitin i.m. when called 

into the operating room. 

Cefoxitin was diluted with 

0.5% lidocaine without 

epinephrine in the hip

Timing of intervention: 

preop or postop

Duration of intervention: up 

to 12h postop 

Device/agent: cefoxitin

Control group: n=54

3dose: patients received 1 

preoperative dose of 2g 

cefoxitin i.m. when called 

into the operating room. 

Cefoxitin was diluted with 

0.5% lidocaine without 

SSI 

1dose: 1/58 (1.7%)

3dose: 2/54 (3.7%)

Length of stay: 

No difference : days ±SD: 

1dose: 4.4±1.1 

3dose: 4.7±1.2 days

Definitions: 

Minor postop 

infection: cystitis 

– when a woman 

had lower urinary 

tract irritative 

symptoms and 105

or more colonies 

of a single 

uropathogen per 

milliliter of urine.

Major postop 

infection: pelvic 

cellulitis – an 

extra-peritoneal 

infection involving 

primarily the 

parametrial 

tissues. This 

involved 
Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminated by the Centers for Disease Control and Prevention 

and should not be construed to represent any agency determination or policy. 90

Author

Year

(Data 

Extractor)

Study 

Design

Quality 

Score

Study Objective Population and Setting Intervention Results Comments

cephalosporins, 

cephamycins, or 

lidocaine; history of 

immediate 

hypersensitivity 

reaction to penicillin; 

history of 

antimicrobial therapy 

within the 48h before 

surgery; temperature 

of greater than or 

equal to 38oC during 

the 24h before 

surgery, concomitant 

infection or any other 

condition that might 

preclude accurate

evaluation of response 

to therapy.

epinephrine in the hip;

this was followed by 

intravenous infusion of 2g 

cefoxitin dose at 6 & 12h 

postop.

Standard preventive 

measures: 

Povidone-iodine douche was 

taken the night before the 

surgery

complaints of 

increasing lower 

abdominal and/or 

pelvic pain, 

tenderness to the 

gentle deep 

palpation of the 

inferolateral 

abdominal wall, 

and an elevated 

temperature. 

Tenderness was 

always 

asymmetrical. 

Perioperative care: 

NR 

Other notes: none

Follow-up: 3-6 

weeks postsurgery.

Austin

1980 27

(ES)

RCT

1

To examine the 

effect the need 

for 

chemoprophyla

xis beyond the 

immediate 

operative 

period in 

Aortocoronary 

Bypass 

procedures.

Number of patients: 

n=85

Patient Characteristics

Findings of the two 

groups were similar

Procedures: 

aortocoronary bypass

Setting: 1 university 

hospital

Location: Canada

Dates: Sept 1, 1977 –

June 30, 1978

Inclusion Criteria: All 

patients who 

underwent 

aortocoronary bypass 

Intervention group: n=38

2dose: Patients who received 

cephalothin 2g 

intravenously 

immediately before 

cardiac bypass was begun 

and 2g at the end of the 

operation.

Timing of intervention: pre 

and postop.

Duration of intervention: 

either for the surgery or 

up to 3days postop.

Device/agent: cephalothin

Control group: n=47

3days: Patients who received 

SSI 

Superficial sternal SSI

2dose: 1/38

3days: 1/47 f/u NR

Antimicrobial resistance:

Both incisional SSIs were 

Staphylococcus aureus

Length of stay

Significantly shorter length of 

stay with postoperative 

AMP in one small (N=85) 

RCT with data collected 

35 years ago:

 2dose: 12.03±4.2

Definitions: 

Infections: diagnosed 

clinically and 

supported by total 

and differential 

leukocyte counts, 

by local cultures 

and by blood 

cultures and 

roentgenograms 

where indicated.

Duration of 

hospitalization: 

defined as the 

number of days 

form operation 
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and should not be construed to represent any agency determination or policy. 91

Author

Year

(Data 

Extractor)

Study 

Design

Quality 

Score

Study Objective Population and Setting Intervention Results Comments

operation at the study 

hospital during the 

study dates.

Exclusion Criteria: IF 

patients had a history 

of an accelerated 

allergic reaction to 

penicillin or allergy to 

cephalosporins, or if 

they refused to give 

consent.

cephalothin 2g 

intravenously 

immediately before 

cardiac bypass was begun 

and 2g at the end of the 

operation. This was then 

followed by 1g 

cephalothin q6h for 3 

days.

Standard preventive 

measures: 

Skin prep: surgical field was 

sprayed with a 

combination of polymyxin 

and bacitracin.

 3day: 14.6±7.5 days

 P<0.05

until discharge.

Perioperative care: 

NR 

Other notes: None

Follow-up: NR

Conte

1972 26

(ES)

RCT

1, 3, 4, 

5, 6, 7

To evaluate 

single-dose 

versus multiple 

dose regimens 

of cephalothin 

in patients 

undergoing 

cardiac surgery.

Number of patients: 

N=64

Patient Characteristics

The groups were 

randomly distributed 

and did not differ 

significantly.

Procedures: cardiac 

surgery

Setting: 1 university 

hospital

Location: USA

Dates: 1969 – December 

1970

Inclusion Criteria: 

patients scheduled for 

cardiac surgery with 

cardiopulmonary 

bypass.

Intervention group: n=30

1dose 1g cephalothin 

intravenously during 

surgery.

Timing of intervention: pre, 

intra and postop

Duration of intervention: 

intraop or from the night 

before surgery until 4th

day postop

Device/agent: cephalothin

Control group: n=34

20dose: received 1g 

cephalothin before, 

during and after surgery 

at 6 hour intervals from 

6pm the night before the 

surgery until noon of the 

4

th postop day.

SSI 

Organ/Space Sternal SSI

1dose: 1/30

20dose: 1/34 

Superficial Sternal SSI

1 dose: 2/30 

20 dose: 2/34 

Antimicrobial resistance:

Incisional SSI: The “no 

postoperative AMP 

group” 

1dose: had 1 Staphylococcus 

aureus and 1 

Staphylococcus epidermis 

infection as compared to

20dose: 1 Serratia 

marcescens and 1 

Definitions: 

Major infection: a 

wound infection 

with purulent 

drainage and 

positive cultures 

with our without 

bacteremia that 

required surgical 

drainage and 

prolonged the 

postoperative 

course. 

Minor infection was 

defined as wound 

infection with 

little or no 

purulent drainage, 

a positive culture, 
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and should not be construed to represent any agency determination or policy. 92

Author

Year

(Data 

Extractor)

Study 

Design

Quality 

Score

Study Objective Population and Setting Intervention Results Comments

Exclusion Criteria: 

unwilling to 

participate, if there 

was a language 

barrier, or if there was 

difficulty in 

comprehension to 

prevent performed 

consent. If they were 

under 21 years of age, 

if the case was an 

emergency, if they had 

received penicillin in 

doses greater than 

400,000 units/day or 

any other 

antimicrobials during 

the 2 weeks prior to 

surgery, or if they had 

a history of allergic 

reaction to the 

protocol drug. Also, 

death from a 

noninfectious cause 

within 24h after 

surgery, significant 

deviations from the 

protocol or apparent 

allergy to the protocol 

drug.

Standard preventive 

measures : NR

Enterococcus infection 

Organ/Space Sternal SSI:

1dose: The one case of 

endocarditis was a 

Staphylococcus epidermis

minimal edge 

separation, and a 

rapid response to 

local care.

Perioperative care: 

NR

Other notes: None

Follow-up: 6months 

- 2 years
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and should not be construed to represent any agency determination or policy. 93

RISK OF BIAS ASSESSMENTS OF STUDIES Q1

Systematic Reviews

Author

Year (RefID)

KQ Search 

terms 

described

Databases 

described 

and two 

or more 

databases 

searched

Inclusion/ 

exclusion 

criteria 

described

Number of 

included/ 

excluded 

studies along 

with reasons 

of exclusion 

described

Studies 

screened 

by two 

independent 

reviewers 

for inclusion

Data 

extracted 

by two 

independent 

reviewers

Individual 

study 

quality 

assessed

Heterogeneity 

between study 

results assessed 

qualitatively 

and/or 

quantitatively

Publication 

bias 

assessed

Characteristics 

of included 

studies 

reported in 

evidence table

Funding 

source(s) 

disclosed 

and no 

obvious 

conflict of 

interest

Overall 

Risk of 

Bias

Question 1: Parenteral Antimicrobial Prophylaxis (AMP)

Costantine

2008 1 1       Low

Randomized Controlled Trials

Author

Year (RefID)

KQ Described 

as 

randomized

Randomization 

appropriately 

performed

Described 

as doubleblind

Outcome 

assessor 

blinded

Study 

participant 

blinded

Investigator 

blinded

Attrition 

described

Attrition smaller 

than 10-15% of 

assigned patients

Attrition 

appropriately 

analyzed

Funding source(s) 

disclosed and no 

obvious conflict of 

interest

Overall 

Risk of 

Bias

Question 1: Parenteral Antimicrobial Prophylaxis (AMP)

Aberg

1991 21 1    Moderate

Ali

2006 12 1   High

Austin

1980 27 1  High

Bates

1992 20 1      Low

Becker

1991 35 1         Low

Bernard

1994 28 1         Low

Buckley

1990 9 1     Moderate

Carr

1984 18 1   High

Carroll

2003 32 1      Low

Chang

2005 33 1     Moderate

Conte

1972 26 1       Low

Cuthbertson

1991 5 1     Moderate
Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminated by the Centers for Disease Control and Prevention 

and should not be construed to represent any agency determination or policy. 94

Author

Year (RefID)

KQ Described 

as 

randomized

Randomization 

appropriately 

performed

Described 

as doubleblind

Outcome 

assessor 

blinded

Study 

participant 

blinded

Investigator 

blinded

Attrition 

described

Attrition smaller 

than 10-15% of 

assigned patients

Attrition 

appropriately 

analyzed

Funding source(s) 

disclosed and no 

obvious conflict of 

interest

Overall 

Risk of 

Bias

Fujita

2007 10 1       Low

Garotta

1991 14 1   High

Gatell

1987 13 1        Low

Grundmann

1987 19 1  High

Hall

1998 30 1       Low

Hall

1989 36 1     Moderate

Hasselgren

1984 29 1        Low

Hemsell

1984 23 1        Low

Juul

1987 37 1     Moderate

Karran

1993 42 1    Moderate

Kow

1995 17 1    Moderate

Liu

2008 31 1         Low

Mayer

1993 22 1   High

McArdle

1995 39 1    Moderate

Mendel

1987 38 1  High

Moesgaard

1989 40 1     Moderate

Mohri

2007 43 1       Low

Mui

2005 6 1      Low

Nooyen

1994 25 1      Low

Oostvogel

1987 11 1       Low

Ritter

1989 16 1    Moderate

Su

2005 8 1   High
Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminated by the Centers for Disease Control and Prevention 

and should not be construed to represent any agency determination or policy. 95

Author

Year (RefID)

KQ Described 

as 

randomized

Randomization 

appropriately 

performed

Described 

as doubleblind

Outcome 

assessor 

blinded

Study 

participant 

blinded

Investigator 

blinded

Attrition 

described

Attrition smaller 

than 10-15% of 

assigned patients

Attrition 

appropriately 

analyzed

Funding source(s) 

disclosed and no 

obvious conflict of 

interest

Overall 

Risk of 

Bias

Suzuki

2011 34 1      Low

Tamayo

2008 7 1       Low

Togo

2007 44 1        Low

Turano

1992 24 1  High

Wenzel

1985 41 1      Low

Wymenga

1992 15 1     Moderate
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and should not be construed to represent any agency determination or policy. 96

Q2 NON-PARENTERAL ANTIMICROBIAL PROPHYLAXIS

GRADE TABLE Q2 

Comparison Outcome

Quantity 

and Type of 

Evidence

Findings Starting 

GRADE

Decrease GRADE Increase 

GRADE

GRADE of 

Evidence 

for 

Outcome

Overall 

GRADE of 

Evidence 

Base

Study Quality

Consistency

Directness

Precision

Publication Bias

Large Magnitude

Dose-response

Confounders

Q2. What are the most effective strategies for administering non-parenteral antimicrobial prophylaxis at the surgical incision to reduce the risk of SSI?

Q2B. How safe and effective are topical antimicrobial agents applied to the surgical incision?

Topical antimicrobial agents

Ampicillin vs. 

No topical 

antimicrobial 

agent

SSI* 1 SR 45

 In meta-analysis (N=699) of 4 RCTs in 

colorectal and appendectomy procedures, no 

difference between groups: OR 0.93; 95% CI: 

0.27 – 1.72; p=0.90)

 Both groups received parenteral antimicrobial 

prophylaxis. 

 3 studies used a topical ampicillin in solution 

and 1 topical powder

High 0 0 0 0 0 0 0 0 High High

Chloramphenicol 

vs.

No topical 

antimicrobial 

agent

SSI* 1 RCT 46

 In a study of 92 hip fracture repairs, no 

difference between groups: 12 (13.0%), 4/47 

(8.5%) vs. 8/45 (17.8%); p=0.20. 

 Both groups received parenteral antimicrobial 

prophylaxis

 Chloramphenicol ointment was applies to the 

surgical site at the end of the procedure and 

on postoperative day 3

High 0 0 0 -1 0 0 0 0 Moderate Moderate

Rifampin vs. 

No topical 

antimicrobial 

agent 

SSI* 1 RCT 47

 In a small (N=48), lower-quality study of 

patients after video laparoscopic 

cholecystectomy, use of rifampin associated 

with reduced risk of umbilical port site 

infection (defined as purulent wound leakage: 

(p<0.005) and fewer local signs of 

High -1 0 0 -1 0 0 0 0 Low Low
Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminated by the Centers for Disease Control and Prevention 

and should not be construed to represent any agency determination or policy. 97

Comparison Outcome

Quantity 

and Type of 

Evidence

Findings Starting 

GRADE

Decrease GRADE Increase 

GRADE

GRADE of 

Evidence 

for 

Outcome

Overall 

GRADE of 

Evidence 

Base

Study Quality

Consistency

Directness

Precision

Publication Bias

Large Magnitude

Dose-response

Confounders

inflammation (p<0.001)

 According to results reported in a histogram, 

at 12 hours postoperatively, purulent wound 

leakage was present among 34/48 (70.8%) of 

the study population: 10/24 (41.7%) vs. 24/24 

(100%). At 24 hours: 0/24 vs. 24/24 and by 

postoperative day seven: 0/24 vs. 2/24 of the 

normal saline group. Unclear if any of these 

were truly infections.

 Both groups received parenteral AMP

 Sterile rifampin (250mg) applied to the 

umbilicus (formulation not specified) 

preoperatively, intraoperatively, and 

postoperatively (every 12 hours for 72 hours)

Wound 

dehiscence 1 RCT 47

 Rifampin associated with reduced risk for 

dehiscence (p<0.001)



High -1 0 0 -1 0 0 0 0 Low

Autologous Platelet Rich Plasma

Autologous 

platelet rich 

plasma-APRP

(gel or spray) vs. 

No APRP

SSI* 3 RCT 

48,49,50

 In a meta-analysis (N=257) of 3 small RCTs in 

cardiac surgery and total knee arthroplasty, 

use of autologous platelet rich plasma was 

not associated with a difference in SSI (OR: 

0.94; 95% CI: 0.42 – 2.13; p=0.89))

 Each individual study did not find a difference

High 0 0 0 -1 0 0 0 0 Moderate

Moderate

Total wound 

closure 1 RCT 49

 At two weeks after surgery, use of a spray 

was associated with decreased likelihood of 

total wound closure (11% vs. 35%; p=0.02)

High 0 0 0 -1 0 0 0 0 Moderate

Q2C. How safe and effective are antimicrobial-coated sutures; when and how should they be used?

Antimicrobialcoated suture 

(absorbable) 

SSI* 4 RCT 51,

52, 53, 54

 In a meta-analysis (N=420) of 4 RCTs that 

included heterogeneous surgeries and 

patients, no difference in SSI rates was 

High 0 0 0 0 0 0 0 0 High High
Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminated by the Centers for Disease Control and Prevention 

and should not be construed to represent any agency determination or policy. 98

Comparison Outcome

Quantity 

and Type of 

Evidence

Findings Starting 

GRADE

Decrease GRADE Increase 

GRADE

GRADE of 

Evidence 

for 

Outcome

Overall 

GRADE of 

Evidence 

Base

Study Quality

Consistency

Directness

Precision

Publication Bias

Large Magnitude

Dose-response

Confounders

versus Nonantimicrobialcoated suture 

(absorbable and 

non-absorbable)

observed (OR: 0.58; 95% CI: 0.18 – 1.90; 

p=0.37). All studies used triclosan-coated 

suture as the antimicrobial coated suture. 

 1 small (N=101 but SSI reported for N=89), 

multicenter RCT 54 in modified radical 

mastectomy showed no difference at 30 and

90 day follow up: 2/46 (4%) vs. 5/43 (11%); 

p=0.22. Study was designed to evaluate a 

cosmetic outcome as the primary outcome of 

interest. Triclosan-coated suture was used for 

subcuticular skin closure and compared to 

Chinese silk suture used for transcutaneous 

interrupted skin closure.

 1 small (N=100) RCT 51 in appendicitis, no 

difference with closure of the abdominal 

sheath at 1 year follow up: 5/50 (10%) vs. 

4/50(8%); p=0.727; all were superficial SSIs

except for 1 deep SSI in the control group.

 1 larger (N=147) RCT 53 in a mix of pediatric 

general surgery procedures, no difference: 

3/98 (3.1%) vs. 0/49 (0%) at 80 day follow up. 

Level of wound closure was not specified.

 1 small (N=84) RCT 52 in mostly pediatric 

cerebrospinal fluid shunt procedures with 

triclosan-coated suture for closure of the 

galea (not skin) significant reduction in shunt 

infections at 6month follow up: 2/46(4.3%) 

vs. 8/38(21%); p=0.038 at 6 month

ASEPSIS 

score

1 RCT 54

 Total mean ASESPSIS score was lower in the 

triclosan-coated suture group at all times 

measured (day 3, 5, 7, 12, 30, 90) but the 

High 0 0 0 -1 0 0 0 0 Moderate
Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminated by the Centers for Disease Control and Prevention 

and should not be construed to represent any agency determination or policy. 99

Comparison Outcome

Quantity 

and Type of 

Evidence

Findings Starting 

GRADE

Decrease GRADE Increase 

GRADE

GRADE of 

Evidence 

for 

Outcome

Overall 

GRADE of 

Evidence 

Base

Study Quality

Consistency

Directness

Precision

Publication Bias

Large Magnitude

Dose-response

Confounders

difference did not reach statistical 

significance after day 12. Wound 

characteristics were comparable between 

groups at all specified endpoints

Adverse 

eventsproduct 

related

4 RCT 51, 52, 

53, 54

 There were no adverse events related to 

either suture High 0 0 0 0 0 0 0 0 High

*Critical outcome; OR: Odds Ratio; RR: Risk Ratio; CI: Confidence Interval
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and should not be construed to represent any agency determination or policy. 100

EVIDENCE TABLE Q2

Q2. What are the most effective strategies for administering non-parenteral antimicrobial prophylaxis at the surgical incision to 

reduce the risk of SSI?

A. How safe and effective is antimicrobial irrigation? Our search did not identify RCTs or SRs that evaluated the safety and 

effectiveness of antimicrobial irrigation.

B. How safe and effective are antimicrobial agents applied to the surgical incision?

Author

Year

(Data 

Extractor)

Study 

Design

Quality 

Score

Study Objective Population and Setting Intervention Results Comments

Almdahl 

2011 48

(ES)

RCT

1, 2, 7, 

8, 9, 

To explore the 

potential of 

Platelet-rich 

plasma (PRP) 

spray 

treatment to 

prevent leg 

wound

infections from 

open 

saphenous vein 

harvesting for 

Coronary Artery 

Bypass Graft 

(CABG)

Number of patients: 

N=139

Patient Characteristics: 

Relevant baseline 

variables were well 

matched between 

groups except the 

lesser preoperative 

use of statins in the 

control group (see 

below)

·Age y, (mean±SD)

 Intervention: 64.8±8.6

 Control: 66.0±8.8

·Gender (% male)

 Intervention: 84.1%

 Control: 84.3%

·Obesity: BMI kg/m2

(mean)

 Intervention: 27.2±3.9

 Control: 27.7±3.8

·Comorbidities

Current smoker 

 Intervention: 21.7%

 Control: 14.3%

Previous smoker

 Intervention: 31.9%

 Control: 47.1%

Intervention group: n= 69

PRP was sprayed on the 

wound immediately 

before closure. Platelet 

pure plasma (PPP) was 

applied after wound 

closure.

Timing of intervention: 

Intraoperatively

Duration of intervention: 

Intraoperatively

Device/agent: Platelet-rich 

plasma spray (made using 

autologous thrombin). A 

measure of 55cc whole 

blood was collected giving 

about 7ccof PRP and 

about 30cc of platelet 

pure plasma (PPP). 

Monitoring intervention: NR

Control group: n= 70

Standard surgical technique 

with no additional wound 

spraying or applications.

Standard preventive 

measures:

Vein harvesting: undertaken 

by the full open 

SSI: (Day 3 and 6 w postop)

ASEPIS Score (Day 3)

 Intervention: 13 patients & 

total scores 33 

 Control: 14 patients and 

total scores 34 

 P=0.51

Harvest Site Infection (6 

weeks):

Overall: 17/139 (12%)

 Intervention: 9 (13%)

 Control: 8 (11%)

 P=0.80 (95%CI: -13% to 9%)

There was no correlation 

between early (day 3) 

secretion and 

development of wound 

infection (p=0.64)

Positive cultures

 Intervention: 6

 Control: 4

All contained S. aureus 

except in one with B. 

fragilis and one 

betahemolytic 

Streptococcus

Other infections: NR

Topic-specific outcomes:

Definitions: 

SSI: ASEPSIS Score 

(day 3); CDC 

definitions (6w 

postop).

Perioperative care: 

Same between 

groups.

Other notes: The 

confounding 

effect of statins is 

explained to have 

minor importance 

and it doesn’t 

affect the 

conclusions.

They had expected 

an SSI rate of 20% 

with goal of 15% 

reduction to 5% 

with PRP 

treatment (not 

achieved).

Follow-up: Wounds 

were inspected at 

day 3 (ASEPSIS 

Score). 6 weeks 

postoperatively, 
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and should not be construed to represent any agency determination or policy. 101

Author

Year

(Data 

Extractor)

Study 

Design

Quality 

Score

Study Objective Population and Setting Intervention Results Comments

Diabetes %

 Intervention: 23.2%

 Control: 18.6%

Statin %

 Intervention: 94.2%

 Control: 78.6%

 P=0.01

Procedures: CABGrelated open 

saphenectomy 

Indications: NR

Setting: I hospital

Location: Norway

Dates: January – October 

2008

Inclusion Criteria: 

Patients undergoing 

first-time CABG using 

cardiopulmonary 

bypass and cold 

crystalloid cardioplegic 

arrest 

Exclusion Criteria:

Patients with bleeding 

disorders and those on 

immunosuppressive 

medication (including 

cyclooxygenase (COX)-

II inhibitors).

technique.

Closure: harvest wound was 

closed with 

intracutaneous 

poliglecaprone according 

to local routine.

Antimicrobial prophylaxis: 2g 

intravenous cephalothin 5 

times until the first 

postoperative day.

Cosmetics (Self scored: 1-10)

 Intervention: mean 8.7 

(range 2-10, median 9)

 Control: mean 8.6 (range 5-

10, median 9)

 P=0.34

Top Score (10)

 Intervention: 29 (42.0%)

 Control: 18 (25.7%)

 P=0.50

Reoperations: NR

Length of stay: NR

Mortality: All patients 

survived

Adverse events: No 

treatment related adverse 

events were observed.

Note: 3 intervention and 4 

control patients who 

fulfilled SSI criteria 

received antimicrobial 

treatment without prior 

microbiological specimen.

the patients were 

called and 

assessment of 

wound infection 

occurrence was 

made according 

to a specific form 

(CDC criteria). 

Follow-up was 

100%.
Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminated by the Centers for Disease Control and Prevention 

and should not be construed to represent any agency determination or policy. 102

Author

Year

(Data 

Extractor)

Study 

Design

Quality 

Score

Study Objective Population and Setting Intervention Results Comments

Litmathe

2009 50

(ES)

RCT

1, 3, 4, 

5, 

To answer 

whether the 

application of 

autologous 

platelet gel 

(APG) will lead 

to a reduction 

in sternal 

wound and 

vessel harvest 

site infections 

and a reduction 

in 

postoperative 

blood loss in 

high-risk 

patients 

undergoing 

cardiac surgery.

Number of patients: 

N=44

Patient Characteristics: 

·Age mean±SD; years

 Intervention: 65.8±8.1

 Control: 66±9.1

·Gender: m:f

 Intervention:14:8

 Control: 17:5

·Obesity: mean BMI±SD; 

kg/m2

 Intervention: 32.4±4.3

 Control:34.2±12.3

·Comorbidities

Diabetes Mellitus: 44/44 

patients

IDDM: 10/22 (45.5%) in 

each group

Procedures: Elective 

Coronary artery 

bypass grafting (CABG) 

or combined coronary 

surgery and valve 

replacement without 

redo.

Indications: NR

Setting: 1 hospital

Location: Germany

Dates: NR

Inclusion Criteria: All 

patients at risk for the 

development of 

surgical wound 

infections who 

required cardiac 

Intervention group: n= 22

Autologous platelet gel 

(APG) was applied to the 

surgical wounds. This 

included the sternal bone, 

the presternal soft tissue, 

and the vein-harvesting 

site.

Timing of intervention: 

Intraoperatively 

Duration of intervention:

Application time

Device/agent: Autologous 

platelet gel (APG) 

prepared using a max of 

16ml whole blood 

collected through an 

existing line and 

anticoagulated with 

citrate dextrose solution. 

Per patient a maximum of 

9-30ml of platelet-rich 

plasma was produced. 

Monitoring intervention: NR

Control group: n= 22

The sternal wound and vein 

harvesting site received 

conventional treatment 

only

Standard preventive 

measures:

Anti-platelet drug 

medication: (at least 

aspirin) 7 days prior to 

surgery.

SSI: (follow up 40 days)

No statistically significant 

differences in healing 

between groups.

Major sternal bone and soft 

tissue complication 

leading to surgical 

revision (with satisfactory 

results after secondary 

surgery):

Total 4/44 (9%)

Intervention: 1/22 (4.5%)

Control: 3/22 (13.6%)

Major healing complications 

at vein harvest site 

(successfully treated with 

vacuum assisted closure 

therapy)

Total: 4/44 (9%)

Intervention: 2/22 (9%)

Control: 2/22 (9%)

Other infections: NR

Topic-specific outcomes: The 

need of transfusion was 

lower in the intervention 

group but not statistically 

significant.

Cumulative ventilation time

 Intervention: 11.7±8.4h

 Control: 14±12.2h

 P=0.5

Drainage blood loss at 6, 12h 

and before removal of 

chest tube was slightly 

Definitions: NR

Perioperative care: 

Surgical techniques: 

CABG was 

performed using 

the standard 

approach of a 

median 

sternotomy using 

the 

extracorporeal 

circulation (ECC) 

and warm blood 

cardioplegia 

according to 

Calafiore. 

Combined 

procedures were 

carried out using 

cold crystalloid 

cardioplegic 

solution

Other notes: Wound 

healing data was 

presented in bar 

graphs.

Follow-up: at 4, 15 

and 40 days.
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Study Objective Population and Setting Intervention Results Comments

surgery including 

those with diabetes 

mellitus, obesity 

(BMI>25kg/m2, active 

smoker, peripheral 

vascular disease and 

heart failure according 

to NYHA III-IV.

Exclusion Criteria:

Emergency 

operations, active 

endocarditis, lung 

infections or 

pneumonia, i.v. drug 

abuse, HIV or 

thrombopenia.

higher for intervention 

group but not statistically 

significant

Total ~1000ml vs. 800ml; 

P=0.14

Reoperations:

Surgical revision:

 Intervention: 1/22 (4.5%)

 Control: 3/22 (13.6%)

Calculated and 

microbiologically specific 

antimicrobial drug 

therapy was applied in all 

4 cases.

Vacuum assisted closure 

therapy was utilized to 

heal vein harvesting site 

was used in 2 patients in 

each group (9.1%)

Length of stay:

ICU stay slightly shorter in 

intervention group:

48.6±44.4 h vs. 51.3 ±53.3h; 

p=0.67

Mortality: NR

Adverse events:

One patient in each group 

(4.5%) underwent reintubation due to 

cardiopulmonary failure.

NOTE: Lowest rectal 

temperature showed 

hypothermia in both 

groups but they do not 

specify when this was 

recorded or if it was 
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Study Objective Population and Setting Intervention Results Comments

corrected

34.2○C±1.4 vs. 34.4○C±1.4; 

p=0.5

Peerbooms

2009 49

(ES)

RCT

1, 3, 4, 

5, 6, 7, 

8, 9, 

To investigate 

whether the 

application of a 

platelet 

concentrate (in 

spray form) 

might improve 

the repair of 

wounds after 

primary 

unilateral total 

knee 

arthroplasty 

(TKA) with a 

primary focus 

on wound 

healing and a 

secondary focus 

on knee 

function, use of 

analgesics, and 

hemoglobin 

values.

Number of patients: 

N=102 but complete 

data were recorded 

for 73 patients. 

Denominators in 

results vary.

Patient Characteristics: 

Baseline patient 

characteristics were 

similar between 

groups.

Both groups had normal 

wound healing. 

Missing data was 

analyzed to compare 

per protocol and ITT 

populations and no 

differences were 

found

·Age: mean (SD) years

 Intervention: 77 (4.4)

 Control: 78 (5.1)

·Gender: no (%) male

 Intervention: 13 (26%)

 Control: 11 (21%)

Intervention group: n=32

The wound was dried and 

subcutaneous tissues 

were sprayed with 

approximately 6mL of 

Platelet-Rich Plasma (PRP) 

at a distance of 10-15 cm 

with the knee flexed at 90 

degrees which exposes 

the knee cavity. After 

closure of the joint 

capsule, with the platelet 

poor plasma (PPP) 

fraction (approx. 10mL) 

and the skin was closed 

with staples. 

Timing of intervention:

Intraoperatively 

Duration of intervention: 

Intraoperatively (duration 

of spray time).

Device/agent: Autologous 

platelet gel (APG) 

prepared using a max of 

16ml whole blood 

collected through an 

SSI: (follow up 3 months)

Superficial wound infection 

at 2 weeks

 Intervention: 1 (2.8%)

 Control: 1 (2.2%)

Both were successfully 

treated with antibiotics.

Total wound closure

Third day postop

 Intervention: 7/32 (21.8%)

 Control: 6/41 (14.6%)

 95% CI: 7% (-11% to 25%) 

P=0.5

Fourth day postop

 Intervention: 7/32 (21.8%)

 Control: 13/41 (31.7%)

 95% CI: -9% (-30% to 10%) 

P=0.4

Two weeks postop

 Intervention: 4/36 (11.1%)

 Control: 16/46 (34.9%)

 95% CI: -24% (-41% to 17%) 

P=0.02

Other infections: NR

Definitions: 

SSI: a wound score 

form was used for 

scoring wound 

healing: where 0 = 

dry wound with no 

signs of infection and 

100=wound leakage 

with signs of 

infection. Wound 

scoring was 

conducted by a 

blinded trained 

orthopedics resident

Wound Closure: 

wound score 0: no 

leakage or signs of 

infection 

Wound leakage: 

scores>0

WOMAC Score 

utilized to 

determine pain, 

stiffness and 

physical function

Perioperative care: 
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Study Objective Population and Setting Intervention Results Comments

·Obesity (exclusion 

criteria)

Height: mean (SD) cm

 Intervention: 168 (9.1)

 Control: 168 (8.1)

Weight: mean (SD) kg

 Intervention: 83 (16)

 Control: 79(12)

·Comorbidities: NR 

(exclusion criteria)

Procedures: Primary 

unilateral total knee 

arthroplasty. (TKA)

Indications: 

Osteoarthritis of the 

knee.

Setting: 1 training 

hospital

Location: The 

Netherlands

Dates: June 2005 – March 

2007

Inclusion Criteria: No age

limit for inclusion but 

the criteria for 

participation included 

pain and radiographic 

knee osteoarthritis.

Exclusion Criteria:

Platelet count 

≤150x109/L, 

hemoglobin level 

≤6.5mmol/L, 

BMI>33kg/m2, and 

systemic disorders 

such as diabetes, 

existing line and anticoagulated with citrate 

dextrose solution. Per 

patient a maximum of 9-

30ml of platelet-rich 

plasma was produced. 

Monitoring intervention: NR

Control group: n-41

Received no spraying with 

PRP or PPP 

Standard preventive 

measures:

Surgical procedure: all 

procedures took place in 

a training hospital using 

the same surgical 

procedure performed by 

an orthopedic consultant 

or a supervised senior 

orthopedic resident.

Surgical Approach: The 

medial parapatellar 

approach was used, 

averting the patella 

laterally.

Tourniquet: was used and 

after implantation, the 

tourniquet was deflated 

and primary hemostasis 

was achieved.

Prosthesis: A cemented 

posterior cruciate 

retaining prosthesis was 

used in all cases.

Irrigation: before closure of 

Topic-specific outcomes:

Using N=102, Drop in 

hemoglobin, pain at rest, 

pain during walking, use 

of pain medication, 

WOMAC score, and Range 

of motion were not 

statistically significantly 

different between control 

and intervention. 

Reoperations: NR

Length of stay: NR

Mortality: NR

Adverse events: NR

Knee incision was 

dressed 

postoperatively 

wit compression 

bandages and 

rehabilitation was 

started on the day 

after surgery 

using crutches 

according to the 

Joint Care 

Program (created 

by the medical 

instrumentation 

company who 

sponsored this 

study).

Other notes: Due to 

a partial 

reorganization of 

the ward, no or 

partial

measurements 

were recorded for 

a number of the 

study patients. 

Missing data were 

attributed to the 

“last known result 

carried forward” 

principle. This 

resulted in a loss 

of power for the 

study.

Follow-up: Wound 

and function 
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rheumatoid arthritis, 

and hepatitis.

the wound layers, the soft 

tissues and knee joint 

were rinsed with saline 

solution to remove all 

debris

Drains: Deep or 

subcutaneous drains were 

not used.

Analgesic: paracetamol (3g 

daily) and diclofenac 

(50mg 3 times daily) with 

pantaprazol (40mg daily) 

for protection against 

ulcers.

Anticoagulant: subcutaneous 

injection of 0.3mL lowmolecular-weight-heparin 

daily before the operation 

and continued until a 

sufficient effect of oral 

anticoagulants 

(acenocoumarol) was 

achieved.

Non-standard preventive 

measures: 

Anticoagulant: oral 

anticoagulants were used 

up to 12 weeks 

postoperatively.

scores were 

measured at days 

3-5, and at regular 

control every 2 

weeks. Functional 

scores were also 

measured at 6 

and 12 weeks 

postoperatively.
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Neri

2008 47

(ES)

RCT

1, 7, 8, 

9

To evaluate the 

use of topical 

prophylactic 

antimicrobial

(i.e., rifamycin) 

for prevention 

of post- video 

laparoscopic

cholecystectom

y (VLC) at the 

umbilical portsite.

Number of patients: 

N=48

Patient Characteristics: 

·Age mean (range): 

 38 (21-64) years

·Gender m:f: 418:30

·Obesity

·Comorbidities

Procedures: Videolaparoscopic 

cholecystectomy (VLC)

Indications:

uncomplicated 

cholelithiasis

Setting: 1 university 

hospital.

Location: USA

Dates: September 2006 –

April 2007

Inclusion Criteria:

Patients with 

uncomplicated 

cholelithiasis 

undergoing 

uncomplicated videolaparoscopic 

cholecystectomy (VLC)

Exclusion Criteria: Acute 

cholecystitis with 

localized peritonitis; 

umbilical hernia; 

immunodepressed 

patients; 

uncompensated 

diabetes; perforation 

of the gallbladder in 

Intervention group: n=24

12 hr. Preop:

 Disinfection of the 

umbilical and periumbilical 

skin with iodopovidone

 Application of a sterile 

medication with 3ml of 

rifamycin (250mg) on the 

umbilicus

Intraop:

 Suture of the umbilical 

access: muscular fascia and 

of the skin wound with 

polyglycolic sutures

 Disinfection of the 

umbilical wound and periumbilical skin with 

iodopovidone first then with 

0.9% saline solution.

 Application of a sterile 

medication with 3mL of 

rifamycin (250mg) on the 

umbilical wound.

Postoperative.

 At 12, 24, 36, 48 & 72 h 

post-VLC, rifamycin was 

applied in a sterile fashion 

to the umbilical wound of all 

the patients.

Timing of intervention: Pre, 

intra and postoperative

Duration of intervention:

from 12hours prior to VLC 

to 72 hours 

All data presented in bar 

graph rather than 

numerical form.

SSI: (follow up 60 days)

Topical administration of 

rifamycin reduced the 

incidence of omphalitis

(statistically significant)

Mean values of local signs of 

inflammation was 

statistically significantly 

higher in the control 

versus the intervention 

group (P<0.001)

Occurrence of umbilical 

wound leakage was 

statistically significantly 

lower at 12, 24, 36, and 

48, and day 3, 4, 5, 6 and 

7 in the intervention 

versus control group 

(p<0.005)

Dehiscence of umbilical 

wound sutures occurred 

in fewer patients in the 

intervention versus 

control groups at 12, 24, 

36, and 48, and day 3, 4, 

5, 6 and 7 (p<0.001)

Other infections: NR

Topic-specific outcomes:

Pain- postoperative 

observation of pain 

localized in umbilical 

region in patients in both 

Definitions: NR

Parameters 

evaluated:

 Umbilical region 

pain (pain scale 0-5)

 Analgesic drug 

administration for 

localized umbilical 

region pain

 Signs of 

inflammation 

(rubor, calor, tumor) 

of the umbilical 

wound (on a scale of 

1-5) including 

wound warmness, 

hyperemia, 

umbilical wound 

swelling and redness

 Purulent leakage 

through the 

umbilical wound.

 Dehiscence of the 

umbilical skin 

sutures.

 Incisional hernia in 

umbilical region at 

postoperative day 

#60

Perioperative care: 

NR

Other notes: none

Follow-up: Clinical 

data were 
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the peritoneal cavity 

during VLC; and 

perforation of the 

gallbladder during 

removal through the 

umbilicus with bile 

leakage.

postoperatively.

Device/agent: Topical 

rifamycin

Monitoring intervention: NR

Control group: n=24

12 hr. Preop:

 Disinfection of the 

umbilical and periumbilical 

skin with iodopovidone

Intraop:

 Suture of the umbilical 

access: muscular fascia and 

of the skin wound with 

polyglycolic sutures

 Disinfection of the 

umbilical wound and periumbilical skin with 

iodopovidone first then with 

0.9% saline solution.

Standard preventive 

measures:

Laparoscopic technique: 

Hasson open technique

AMP: IV administration of 2g 

ceftriaxone, followed by a 

second intraoperative 

dose and a final dose 

after 24 hours.

groups statistically less in 

intervention group 

(P<0.001)

Number of patients requiring 

additional analgesics 

(yes/no) presented in bar 

graph form but shows 

fewer patients in 

intervention than control 

requiring additional 

analgesics at hour 12, 24, 

36, and 48, and day 3, 4, 

5,and 6

 P<0.005

Reoperations: NR

Length of stay: Mean 

(range)

 Intervention: 3 (1-8) days

 Control: 4 (3-8) days.

Mortality: NR

Adverse events:

registered at 12, 

24, 36 and 48h 

after VLC and on 

the 3rd, 4th , 6th, 

and 7th post-VLC 

day. For patients 

dismissed before 

3

rd postoperative 

day, there was an 

ambulatory 

outpatient control 

on the 60th day 

post-VLC, the 

possible presence 

of incisional 

hernia in the 

umbilical region 

was registered.
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Kamath

2005 46

(ES)

RCT

1, 4, 6, 

7, 8, 9, 

To study the 

role of the 

topical 

antimicrobial 

chloramphenic

ol in reducing 

the incidence of 

superficial 

surgical site 

infection 

following 

surgery for hip 

fractures. 

Number of patients: 

N=92

Patient Characteristics: 

·Age: mean 78.6 (44-101) 

years

·Gender: m:f = 28:72

·Obesity NR

·Comorbidities:

Rheumatoid arthritis:4

Diabetes: 9

Cardiac, respiratory, renal 

or other systemic 

pathology: 91

Smoking history (current 

or past): 100%

Preop hospitalization: 

average 1.7 days (1-8)

Procedures: 

Hemiarthroplasty 

(uncemented 

prosthesis) 54/92 

(58.7%)

Internal fixation of the 

fracture with dynamic 

hip screw: 46/92 

(23.9%)

Indications: fracture of 

the neck of femur

Intracapsular fracture: 

54/92 (58.7%)

Extra capsular fracture: 

46/92 (23.9%)

Setting: 1 hospital

Location: Scotland

Dates: April 2002 –

March 2003

Intervention group: n= 47

Topical chloramphenicol 

ointment was applied to 

the surgical site at the 

end of procedure and 3rd

day postoperatively and 

wound dressed with low 

adherence dressing 

(rayon absorbent pad 

with adhesive border)

Timing of intervention: Intra 

and postoperatively

Duration of intervention:

intra and postoperatively

Device/agent:

Chloramphenicol

Monitoring intervention: NR

Control group: n=45

No antimicrobial ointment 

administered. Wound 

dressed with low 

adherence dressing 

(rayon absorbent pad 

with adhesive border)

Standard preventive 

measures:

AMP: intravenous 

cefuroxime

Anticoagulant: postoperative 

subcutaneous injection of 

enoxaparin for DVT 

prophylaxis 

Non-standard preventive 

measures:

Closure: 

Clips: 97/100 (97%) 

SSI: (follow up 30 days)

Superficial Infection:

 Intervention: 4/47 (8.5%)

 Control: 8/45 (17.8%)

Positive wound swabs in 5 of 

8 in control group: 1 

Pseudomonas, 2 MRSA, 2 

MSSA.

None in the intervention 

group had positive wound 

swabs.

Univariate estimated relative 

risk (95% CI) of infection

Smoking (no infected (%))

 Current: 8/31 (25.8%)

 Former/never: 4/61 (6.6%)

 RR: 4.957 (1.359-18.084)

Gender (no infected (%))

 Male: 5/25 (20%)

 Female: 7/67 (10.4%)

 RR: 2.143 (0.611-7.512)

Age (no infected (%))

 >71 years: 10/70 (14.3%)

 >70 years: 2/22 (9.1%)

 RR: 1.667(0.335-8.259)

Treatment (no infected (%))

 Intervention: 4/47 (8.5%)

 Control: 8/45 (17.8%)

 RR: 0.430 (0.120-1.544)

Multivariate estimated 

relative risk (95% CI) of 

infection

Current Smoker:

 ARR: 7.29 (1.62-32.67); 

Definitions: 

Surgical site 

surveillance was 

based on the 

guidelines issued 

by the Scottish 

Centre for 

Infection and 

Environmental 

Health (SCIEH)

Superficial SSI

1. infection occurs 

w/in 30 days after 

operation

2. and involves only 

skin and 

subcutaneous 

tissue of incision

3. Patient has at least 

one of the 

following

·purulent discharge 

form the 

superficial incision

·organisms isolated 

form an 

aseptically 

obtained culture 

of fluid or tissue 

form the 

superficial incision

·at least one of the 

following signs or 

symptoms of 

infection: pain or 

tenderness, 
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Study Objective Population and Setting Intervention Results Comments

Inclusion Criteria:

Patients who could 

give informed consent 

and who were 

admitted with fracture 

neck of femur.

Exclusion Criteria:

Pathological fractures 

and undisplaced 

intracapsular neck of 

femur fractures 

needing internal 

fixation.

(removed 12 days postop)

Subcuticular stitches: 2/100 

(2%)

Interrupted nylon: 1/100 

(1%)

Grade of surgeon:

Middle grades: 82/100 (82%)

Senior house officers under 

senior supervision: 

10/100 (10%)

Consultant: 8/100 (8%)

P=0.009

Male Gender 

 ARR: 0.92 (0.19-4.31); 

 P=0.912

Age<70 years

 ARR: 0.30 (0.05-1.96)

 P=0.209

IC Fracture:

 ARR: 0. 52 (0.06-1.13); 

 P=0.072

Treatment: Intervention: 

 ARR: 0.36 (0.08-1.56); 

 P=0.172

Other infections:

Chest infections: 7/92 (7.6%)

 1/7: intervention and also 

had wound infection

 1/7: control and also had 

wound infection

UTI: 5/92 (5.4%)

 1/5: control and also had 

wound infection

Topic-specific outcomes: 

9 patients in the study had 

no associated illness and 

none of these had wound 

infections.

Reoperations: NR

Length of stay: average 

inpatient stay: 18.5 (10-

90) days either in an 

orthopedic ward or 

rehabilitation ward 

following which patients 

were either sent back to 

localized swelling, 

redness or heat 

and superficial 

incision, is 

deliberately 

opened by 

surgeon unless 

incision is culture 

negative.

·Diagnosis of SSI by 

physician. 

The following are 

NOT SSI

1. Stitch abscess 

(minimal 

inflammation and 

discharge confined 

to the points of 

suture penetration)

2. Infected burn 

wound

3. incisional SSI that 

extends into the 

fascial and muscle 

layers (Deep 

incisional SSI)

Perioperative care: 

Mobilization: 

according to 

standard protocol. 

Other notes: None

Follow-up: The 

wound was 

checked on the 

3

rd, 6th, 12th and 

30th day postop
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their own home or care 

home as appropriate.

Mortality: 7 patients died 

because of unrelated 

causes during follow up.

1/7 hemiarthroplasty had 

malignancy confirmed on 

histology & excluded.

Adverse events:

1 Intervention and 2 control 

patients’ wounds 

continued to discharge 

through sinuses for up to 

3 months but all 

eventually settled down 

with oral antimicrobials 

and dressings.

Charalambous

2003 45

(RA)

SR

1, 2, 3, 

4, 5, 7, 

8, 10

To determine 

whether topical 

ampicillin can 

reduce the rate 

of wound 

infections in 

clean, 

contaminated 

or 

contaminated

surgical wounds 

(appendectomy

, colorectal 

surgery or 

these with 

perforation, 

gangrene or 

pus)

Study types: RCT

N: 9 RCTs, N of 

participants not reported

Inclusion criteria: RCTs 

evaluating the use of 

topical ampicillin as a way 

of infection prophylaxis in 

colorectal and 

appendectomy surgical 

wounds.

Exclusion criteria: NonEnglish studies

Databases searched:

MEDLINE, Advanced 

MEDLINE, CENTRAL 

Intervention: Topical 

ampicillin 

Comparison:

Control 1: No concomitant 

systemic antimicrobial 

prophylaxis

Control 2: WITH concomitant 

systemic antimicrobial 

treatment. The exact timing 

of administration was not 

described.

Wound infection: 

All results intervention vs. 

control – OR(95% CI):

Topical antimicrobials vs. no 

concomitant systemic 

antimicrobial prophylaxis –

clean contaminated wounds:

(5 studies): 0.08 (0.04-0.16); 

Q for heterogeneity – 55.72, 

P<0.0001

Topical antimicrobials vs.–no 

concomitant systemic 

antimicrobial prophylaxis 

contaminated wounds (3 

studies):

0.26 (0.14-0.51); Q for 

heterogeneity 17.53; 
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(searches ended 2001)

Quality assessment: 

Based on method of 

randomization, blind 

outcome assessment, 

written definition of 

surgical wound infection, 

loss to follow-up and 

whether intention to 

treat analysis was done. 

Allocation concealment 

was adequate in 7 

studies, 2 studies were 

blinded for outcome 

assessment, intention-totreat was not reported in 

8 studies and not done in 

1 study 

P<0.0001

Topical antimicrobials + 

concomitant systemic 

antimicrobials vs. systemic 

antimicrobials – clean 

contaminated wounds (4

studies): 

0.93 (0.27-1.72); Q for 

heterogeneity 1.48, P=0.90

C. How safe and effective are antimicrobial-coated sutures; when and how should they be used?

Author

Year

(Data 

Extractor)

Study 

Design

Quality 

Score

Study Objective Population and Setting Intervention Results Comments

Zhang

2011 54

(ES)

RCT

1, 2, 3, 

4, 5, 7, 

8, 9, 

Primary 

objective: To 

compare the 

cosmetic 

outcomes of 

antimicrobial 

coated 

absorbable 

sutures to silk 

sutures 

Number of patients: 

N=101 (ITT) but SSI 

reported for N=89

Patient Characteristics: 

Baseline 

characteristics were 

comparable between 

the groups.

·Age median(range) y

 Intervention: 51.0 (32.0-

Intervention group: n= 47 

(51+ ITT)

Intradermal closure using 

antimicrobial (triclosan) 

coated absorbable 

sutures

Timing of intervention:

Intraoperatively 

Duration of intervention:

Intra operatively

SSI: (follow up 90 days)

No SSI through day 12.

SSI at Day 30

 Overall: 7/89 (7.9%)

 Intervention: 2/46 (4.3%)

 Control: 5/43 (11.1%)

SSI at Day 90

No other incidence of SSI 

through day 90

Definitions: 

VAS: Visual Analog 

Scale: a blinded 

assessor 

(cosmetic 

surgeon) 

evaluated digital 

photographs 

adding up scores 

according to (0) at 
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and should not be construed to represent any agency determination or policy. 113

Author

Year

(Data 

Extractor)

Study 

Design

Quality 

Score

Study Objective Population and Setting Intervention Results Comments

following 

radical 

mastectomy. 

Secondary 

objective: To 

assess 

incidence of 

SSI.

82.0)

 Control: 52.0 (34.0-

75.0)

·Gender 100% female

·Obesity

BMI median (range) 

kg/m2

 Intervention: 23.9 (16.0-

28.0)

 Control: 23.6 (18.2-

34.0)

·Comorbidities: Excluded 

diabetes, COPD and 

asthma. No smokers 

in the intervention 

group; 1 current and 2 

former smokers in the 

control group

Operative:

>70% Stage IIA or better 

in both groups

 

Procedures: Radical 

Mastectomy

Indications: Cancer

Setting: 6 hospitals

Location: China

Dates: October 2008 –

May 2009

Inclusion Criteria: 

Women aged ≥18 

years, scheduled for 

clean modified radical 

mastectomy, with 

signed hospitalapproved consent and 

Device/agent: Triclosancoated absorbable 

sutures.

Monitoring intervention:

Control group: n=46 (50=ITT)

Simple interrupted closure 

using silk sutures.

Standard preventive 

measures:

Unified standard of care: All 

investigators were trained 

during an investigator 

meeting to consolidate 

modified radical 

mastectomy. 

Investigators performed 

the procedure and closed 

the skin incision in 

accordance with unified 

standard of care

Total mean ASEPSIS Scores of 

the Intervention group 

was lower (fewer signs of 

infection) vs. Controls at 

all measured times. 

(similar results with CDC 

Criteria) Actual ASEPSIS 

scores and type of SSIs 

not reported.

Other infections: NR

Topic-specific outcomes:

30 day VAS cosmetic 

outcome score

ITT

 Intervention:67.2±18.2

 Control: 45.4±12.0

 P<0.0001

PP

 Intervention:67.6±18.2

 Control: 45.5±11.7

 P<0.0001

12 Day VAS score -- ITT

 Intervention:67.3±12.3

 Control: 46.6±6.5

 P<0.0001

Hollander Cosmetic Score

Total Score Day 12 (mean 

±SD)

 Intervention:5.7±0.8

 Control: 5.2±1.2

 P=0.03

Total score Day 30

 Intervention:5.7±0.5

 Control: 5.0±1.2

one end and “best 

possible scar” 

(100) at the other 

end. A score 

between 0 and 

100 was derived 

by measuring the 

distance between 

a vertical mark on 

the wound and 0.

mHCS: Cosmetic 

outcome was 

measured using 

the Hollander 

cosmetic scale 

(mHCS) at days 12 

and 30 assessed 

by non-blinded 

investigator.

SSIs – Identified using 

ASEPSIS wound 

scores and CDC 

criteria.

Perioperative care: 

NR 

Other notes: This 

was a pilot study 

and not 

statistically 

powered.

Study designed to 

evaluate a 

cosmetic outcome 

as primary 

outcome of 

interest.
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and should not be construed to represent any agency determination or policy. 114

Author

Year

(Data 

Extractor)

Study 

Design

Quality 

Score

Study Objective Population and Setting Intervention Results Comments

CDC surgical wound 

classification of 1.

Exclusion Criteria: (1) 

patients undergoing 

surgery for modified 

radical mastectomy 

with immediate breast 

reconstruction, 

cosmetic breast 

operations, reduction, 

expansion, insertion of 

a prosthesis, duct 

ectasia, or infective 

breast disease or 

implant; (2) patients 

with surgical wounds 

identified as Class II, III 

or IV using CDC SSI 

surgical wound 

classification; (3) 

patients having 

inflammatory cancers, 

skin ulceration; (4) 

known allergy or 

intolerance to 

triclosan; (5) patients 

with anticipated 

compromised wound 

healing or chronic 

immune deficiency 

(e.g., diabetes, 

prolonged steroid use, 

AIDS or substance 

abuse); (6) serious 

heart and/or lung 

disease; (7) skin scar 

 P=0.002

Reoperations: NR

Length of stay: NR

Mortality: None throughout 

the study

Adverse events: Included 

accumulation of fluid, skin 

flap necrosis, gangrene and 

SSI

Subjects with at least 1 

adverse event

 Intervention: 15/51 (29.4%)

 Control: 19/50 (38.0)

Serious (not defined)

 Intervention: 1/51 (2.0%)

 Control: 3/50 (6.0%)

Severe (not defined)

 Intervention: 0/51 

 Control: 2/50 (4.0%)

Possibly related to device 

and procedure

 Intervention: 2/51 (3.9%)

 Control: 3/50 (6.0%)

Related or possibly related to 

device and procedure

 Intervention: 6/51 (11.8%)

 Control: 6/50 (12.0%)

Follow-up:

SSI ASEPSIS Score: 

Patients were 

evaluated at post 

treatment day 3, 5, 7, 

12 (±2), day 30 (±5), 

and day 90 (±7) 

follow up visit

SSI CDC criteria: f/u 

3, 12, 30 and 90 

days.

Cosmetic resultsprimary 

effectiveness 

endpoint 

evaluated at 30 

days postop.
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and should not be construed to represent any agency determination or policy. 115

Author

Year

(Data 

Extractor)

Study 

Design

Quality 

Score

Study Objective Population and Setting Intervention Results Comments

history or family 

history; (8) patients 

who received an 

experimental drug or 

used an experimental 

medical device within 

30 days prior to the 

planned start of 

treatment; (9) 

employees of the 

investigator or study 

center with direct 

involvement in the 

proposed study or 

other studies under 

the direction of that 

investigator or study 

center; (10) in the 

opinion of the 

investigator, unlikely 

to comply with or 

complete the 90-day 

follow up visit

Mingmalai

rak

2009 51

(ES)

RCT

1, 2, 3, 

4, 5, 6, 

7, 8, 9, 

10

To evaluate the 

efficacy of 

triclosan coated 

absorbable 

suture in 

reducing the 

surgical site 

infection rate 

associated with 

appendectomy 

compared with 

traditional, 

non-coated 

Number of patients: 

N=100

Patient Characteristics: 

No statistically 

significant differences 

in demographic 

characteristics, 

preoperative 

information and 

operative information 

between groups.

·Age: year (mean

 Intervention: 29.1

Intervention group: n=50

Antibacterial-coated 

absorbable suture 

(triclosan) was used to 

close the abdominal 

sheath.

Timing of intervention:

Intraoperatively

Duration of intervention:

Intraoperatively 

Device/agent: Antibacterial 

absorbable suture 

(triclosan coated)

SSI: (follow up 12 months)

SSI (total)

Overall rate: 9/100 9%

 Intervention: 5 (10%)

 Control: 4 (8%)

 P=0.727

Superficial

 Intervention: 5 (10%)

 Control: 3 (6%)

Deep

 Intervention: 0

 Control: 1 (2%)

Organ/Space

Definitions: NR

Perioperative care: 

NR 

Other notes: All 

patients 

completed the 

study

Authors set the 

discontinuation 

criteria infection 

rate >10% in the 

intervention 

group or >2 times 
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and should not be construed to represent any agency determination or policy. 116

Author

Year

(Data 

Extractor)

Study 

Design

Quality 

Score

Study Objective Population and Setting Intervention Results Comments

braided 

absorbable 

suture.

 Control: 29.8

·Gender: m:f

 Intervention: 26:24

 Control: 35:15

·Obesity

Height: cm (mean)

 Intervention: 161.5

 Control: 164.0

P=0.039

Weight: kg (mean)

 Intervention: 59.73

 Control: 59.53

·Comorbidities: NR

White Blood Cell count 

(cell/mm3) (mean):

 Intervention: 16,564

 Control: 15,062

 P=0.036

Operative:

Preop time, operative 

time, type of appendicitis 

and degree of 

contamination not 

statistically significant

Type of appendicitis:

Intervention/control

Acute: 24/24

Suppurative: 56/48

Gangrene: 6/10

Ruptured: 14/18

Degree of contamination:

Intervention/Control

Mild: 86/80

Moderate: 8/12

Severe: 6/8

Procedures: 

Monitoring intervention: NR

Control group: n=50

Traditional braided 

absorbable suture was 

used to close the 

abdominal sheath.

Standard preventive 

measures:

AMP: Gentamicin 240mg and 

metronidazole 500mg 

were given intravenously 

30-60 minutes before the 

operation. 

Surgery: appendectomy was 

done with standard 

technique mainly by a 

second year physician.

 Intervention: 0

 Control: 0

Infections were more 

common in cases of 

ruptured appendicitis 

(Infected 5/9 vs. Noninfected 11/91 P=0.007) 

The rate of SSI was higher in 

men than in women. (3:2)

Risk factors associated with 

infection

Infected patients tended to 

be older, with slightly higher 

temperature, higher white 

blood cell counts, and 

slightly longer operative 

times, but these differences 

were not statistically 

significantly different.

Appendicitis case type

Suppurative: 

 Non- infected: 50/91 

(54.9%)

 Infected: 2/9 (22.2%)

 P=0.050

Ruptured: 

 Non-infected: 11/91 

(12.1%)

 Infected: 5/9 (55.6%)

 P=0.007

 

Other infections: NR

Topic-specific outcomes: 

in the control 

group compared 

with the 

intervention. Or 

mechanical 

problems in the 

intervention 

group such as 

strength, knot 

tight and 

anaphylactic 

allergy.

Follow-up: At day 1, 

3, 7, 14, and 30, 

and at 6 and 12 

months
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and should not be construed to represent any agency determination or policy. 117

Author

Year

(Data 

Extractor)

Study 

Design

Quality 

Score

Study Objective Population and Setting Intervention Results Comments

Appendectomy

Via grid-iron incision: 86%

Indications: Acute and 

ruptured appendicitis.

Uncomplicated: 76%

Acute

 Intervention: 24%

 Control: 24%

Suppurative

 Intervention: 56%

 Control: 48%

Gangrene

 Intervention: 6%

 Control: 10%

Ruptured

 Intervention:14%

 Control: 18%

Setting: 1 university 

hospital

Location: Thailand

Dates: August 2006 –

March 2007

Inclusion Criteria:

Patients aged 15-60 

years, both sexes, 

appendicitis was 

diagnosed 

intraoperatively 

through a right lower 

quadrant incision and 

included both acute 

and ruptured 

appendix.

Exclusion Criteria:

Patients with diabetes, 

immunocompromised 

Cultures

Intervention: 1 S. aureus

Control: 1 (deep) P. 

aeruginosa

Reoperations: NR

Length of stay: days (mean)

 Intervention: 3.7

 Control: 3.7

 P=0.500

Infected vs. uninfected.

 Uninfected: 3.6 days

 Infected: 7.4 days

 P=0.006

Mortality: NR (all available 

for follow-up)

Adverse events: No medical 

complications during the 

present study and no 

complications related to 

suture were identified 

after 1 year of follow-up.
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and should not be construed to represent any agency determination or policy. 118

Author

Year

(Data 

Extractor)

Study 

Design

Quality 

Score

Study Objective Population and Setting Intervention Results Comments

host, HIV, on 

immunosuppressive 

drug, malignancy, 

missed diagnosis 

intraoperative, history 

of allergy to the 

substance, or 

pregnancy

Rozzelle

2008 52

(ES)

RCT

1, 2, 3, 

4, 5, 6, 

7, 8, 9, 

10

To determine 

whether wound 

closure with 

triclosancoated 

absorbable 

sutures after 

cerebrospinal 

fluid (CSF) 

shunt surgery 

would reduce 

the incidence of 

early shunt 

infection (<6 

months 

postoperatively

)

Number of patients: N = 

61 patients with 84 

shunt procedures

Patient Characteristics: 

Groups differed 

slightly but no 

significant difference 

was found in patient 

characteristics, shunt 

type, indication, or 

which surgeon 

between groups.

·Age median (range): 6.3 

y (1 day – 48 y)

·Gender: male no (%)

 Intervention: 30 (65%)

 Control: 18 (47%)

 P=0.154

(Distribution unequal 

between groups with a 

weak statistical trend 

towards the 

Intervention group for 

males.)

·Obesity: NA

weight <4kg

Intervention group: n=46

Antimicrobial (triclosan) 

coated absorbable 

sutures were utilized to 

close the subcutaneous 

layer around the CSF 

shunt

Timing of intervention:

Intraoperatively

Duration of intervention:

Intraoperatively

Device/agent: Antimicrobial 

(triclosan) coated sutures

Monitoring intervention:

CSF cultures.

Control group: n= 38

Standard (uncoated)

absorbable sutures were 

utilized to close the 

subcutaneous layer 

around the CSF shunt (not 

the same kind of material 

as the intervention)

Standard preventive 

measures:

SSI: (follow up 6 months)

SSI at 2nd interim period

Overall: 10/84 (11.9%)

 Intervention: 2 (4.3%)

 Control: 8 (21%)

 P= 0.038

There was no statistically 

significant difference 

between historical rate 

and either the 

intervention or control 

group rates.

Intervention was associated 

with

Absolute risk reduction 

 0.167 (95% CI 0.027-0.235) 

Relative risk reduction

 3.84 (95% CI 0.257 – 18.78)

Predict intervention suture 

wound closure would 

prevent 1 shunt infection for 

every 6.0 procedures in 

which it is used:

Number to treat=6.0; 95%CI 

4.2-36.5)

8/10 diagnosed w/in 6 weeks

Definitions: 

Shunt infection: 

diagnosis 

obtained by 

positive culture 

from CSF sampled 

through the shunt 

or from explanted 

shunt 

components. 

Perioperative care: 

NR

Other notes:

No patients were lost 

to follow up.

Patients requiring a 

new shunt within 

the 6-month 

surveillance 

window were 

reenrolled in the 

program using the 

same suture 

assignment as 

before. Patients 

receiving new 
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and should not be construed to represent any agency determination or policy. 119

Author

Year

(Data 

Extractor)

Study 

Design

Quality 

Score

Study Objective Population and Setting Intervention Results Comments

 Intervention: 7 (15%)

 Control: 6 (16%)

·Comorbidities

Recent CSF infection

 Intervention: 6 (13%)

 Control: 3 (8%)

Operative

Mean shunt procedure 

time was slightly 

longer in intervention 

group but not 

statistically significant.

Procedures: Implantation 

or revision of 

implantation for 

cerebrospinal fluid 

(CSF) shunting devices.

Implants: 40 (47.6%)

Revisions: 44 (53.4%)

VP Shunt type: 68 

operations (81%)

VPI Shunt type: 9 

operations (10.7%)

Subdural-peritoneal 

shunt: 6 operations 

(7.1%)

VA shunts: 1 operation 

(1.2%)

Indications: 

hydrocephalus.

Setting: 1 hospital

Location: USA

Dates: April 2005 -

December 2006.

Inclusion Criteria:

Patients of all ages 

Surgeon Grade: all shunt 

procedures were 

performed by one of two 

attending pediatric 

neurosurgeons.

AMP: all participants 

received preoperative 

intravenous 

antimicrobials (cefazolin, 

or vancomycin if allergic 

to cephalosporins)

Skin Prep: all patients 

received preoperative 

chlorhexidine skin 

cleansing, povidoneiodine skin prep.

Drapes: all surgeries utilized 

iodine-impregnated 

adhesive drapes

Wound irrigation: all patients 

received antibiotic wound 

irrigation prior to 

closures.

Shunt cleaning: Silicone 

shunt components were 

soaked in bacitracin 

solution before 

implantation. No 

antibiotic-impregnated 

shunt components were 

used in this study.

Closure: skin closures for all 

procedures were 

performed with 

poliglecaprone 25 

sutures.

2/10 diagnosed at 12 and 14 

weeks postop.

8/10 (+) CSF cultures

1/10 blood and distal 

catheter cultures grew same 

organism (VA Shunt)

1/10 (-) CSF culture, (+) 

wound purulence over distal 

tubing

Other infections: NR

Topic-specific outcomes:

60 shunts (71.4%) remained 

functional and apparently 

infection free at 6 months.

Pathogenic isolates n=10 

SSIs:

Intervention:

 1 MRSA

 1 coagulase negative (coag 

neg) Staphylococcus

Control:

 1 MRSA 

 3 MSSA

 3 coag neg Staph spp.

 1 P. aeruginosa

Reoperations:

10/84 (11.9%) shunts were 

removed due to infection 

prior to 6 month follow 

up.

14/ 84 (16.7%) Revision 

procedures w/in 6 mo 

where infection was not 

suspected. (Shunt tap 

CSF cultures remained 

shunts following 

successful 

treatment of a 

shunt infection 

and patients 

undergoing 

revision >6 

months after 

randomization 

were rerandomized.

Enrollment ceased at 

the second 

interim analysis 

due to a marked 

difference in 

infection rates 

between groups.

No additional shunt 

infections 

diagnosed after 

enrollment ceased

Follow-up: 6 months
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and should not be construed to represent any agency determination or policy. 120

Author

Year

(Data 

Extractor)

Study 

Design

Quality 

Score

Study Objective Population and Setting Intervention Results Comments

requiring CSF shunt 

implantation or 

revision surgery.

Exclusion Criteria:

Patients receiving 

ventricular access 

devices or 

ventriculosubgaleal 

shunts, patients with 

active shunt 

infections, and 

immunocompromised 

patients.

negative)

 2/84 (2.4%) revision 

procedures >6mo postop.

7/61 (11.5%) patients 

receiving new shunts 

were re-randomized after 

removal of an infected 

shunt that had been 

placed during the study 

and appropriate 

antimicrobial therapy

Length of stay: NR

Mortality: 2 patients with 

shunt infections died 

(3.3%). Both were infants 

with severe congenital 

anomalies whose parents 

ultimately decided to 

withdraw care.

Adverse events:

All shunt infections were 

treated with complete 

shunt removal, external 

ventricular drainage, and 

appropriate intravenous 

antimicrobial therapy 

until daily CSF cultures 

remained negative for ≥5 

days, followed by the 

replacement of a new 

shunt. 
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and should not be construed to represent any agency determination or policy. 121

Author

Year

(Data 

Extractor)

Study 

Design

Quality 

Score

Study Objective Population and Setting Intervention Results Comments

Ford

2005 53

(ES)

RCT

1, 4, 5, 

7, 8, 9

To characterize 

further the 

clinical 

performance of 

antimicrobial

(triclosan) 

coated 

absorbable 

suture and 

traditional nonantimicrobial 

coated 

absorbable 

suture in 

pediatric 

patients 

undergoing 

various general 

surgical 

procedures.

Number of patients: 

N=147

Patient Characteristics: 

no differences in 

baseline 

characteristics 

between groups.

·Age mean (range): 9.8 y 

(1-18 years)

·Gender: 52% male

·Obesity: NR

Mean Height: 137.2 cm 

(range 67-191 cm)

Mean Weight: 41.3 kg 

(range 8-130 kg)

·Comorbidities

“Risk factors that could 

affect wound healing 

were present in similar 

proportion”: individual 

results by risk factor 

not reported

 Intervention 29%

 Control: 33%

“The most common risk 

factors were obesity 

and chemotherapy” 

Actual numbers not 

reported

Received IV 

antimicrobials (they 

do not specify if AMP 

or AMP and 

treatment)

 Intervention: 65%

 Control: 82%

Intervention group: n= 98

Antimicrobial (triclosan) 

coated absorbable suture 

was used as suture of 

various sizes dependent 

on surgery

Timing of intervention: 

Intraoperatively

Duration of intervention: 

Intraoperatively

Device/agent: Triclosancoated absorbable suture.

Monitoring intervention: NR

Control group: n=49

Non-antimicrobial coated 

absorbable suture was 

used as suture of various 

sizes dependent on 

surgery

Standard preventive 

measures: NR

Non-Standard Preventive 

Measures:

Perioperative antimicrobial 

administration:

 Intervention: 24%

 Control: 31%

SSI: (follow up 80 days)

Infection Day 1-2

 Intervention: 0%

 Control: 0%

Infection Day 14

 Intervention: 2%

 Control: 0%

Infection Day 80

 Intervention: 1%

 Control: 0%

Edema, any day 1

 Intervention: 10%

 Control: 18%

Edema, any Day 14

 Intervention: 3%

 Control: 2%

Edema, any Day 14

 Intervention: 0%

 Control: 3%

Erythema Day 1

 Intervention: 9%

 Control: 7%

Erythema Day 14

 Intervention: 9%

 Control: 2%

Erythema Day 80

 Intervention: 1%

 Control: 3%

Other infections: 3 infections 

developed that were 

judged not to be related 

to the suture.

1/3: Day 14 a 13 year old 

male undergoing pilonidal 

cystectomy developed a 

new sinus tract that was 

Definitions: 

Infection: observed 

redness >3-5 mm 

from the wound 

margins, edema 

(characterized by 

increased tissue 

firmness), 

purulent 

discharge, pain, 

and increased skin 

temperature. 

Confirmatory 

culture was not 

required.

FLACC behavior pain 

assessment scale 

was used in nonverbal patients 

(infants) unable to 

provide reports of 

pain. (face, legs, 

activity, cry, 

consolability)

Intraoperative 

handling: overall, 

ease of passage, 

first throw, tie 

down, security, 

hand, memory, 

non-fraying.

Perioperative care: 

NR

Other notes:

Patient population at 

each wound 
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and should not be construed to represent any agency determination or policy. 122

Author

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Extractor)

Study 

Design

Quality 

Score

Study Objective Population and Setting Intervention Results Comments

Taking other medications

 Intervention: 5%

 Control: 10%

Procedures: NR (variable)

Indications: NR (variable)

Setting: 1 center

Location: USA

Dates: NR

Inclusion Criteria:

Pediatric patients aged 

1-18 years undergoing 

clean or cleancontaminated general

surgical procedures.

Exclusion Criteria:

Contaminated wound 

sites; use of retention 

sutures; inappropriate 

age; evidence of 

malnutrition or 

debilitation; coexisting 

conditions that may 

impair wound healing 

including acquired 

immunodeficiency 

syndrome (AIDS); 

incision sites prone to 

expand, stretch, 

distend, or require 

support; ophthalmic, 

cardiovascular, or 

neurologic surgical 

sites; a need for more 

than one surgical 

procedures; prior 

participation in this 

related to the location of 

the cyst

1/3: on day 14, a 14 year old 

female who had 

undergone laparoscopic 

cholecystectomy 

developed a superficial 

fungal rash around the 

umbilicus that was 

believed to be due to 

body habitus.

1/3: day 80, a 14 year old 

female patient who 

underwent a pilonidal 

cystectomy developed a 

new sinus tract distal to 

the original site of 

excision that was filled 

with hair (most likely 

represented a new lesion)

Topic-specific outcomes:

Intraoperative handling:

Overall:

 Intervention mean 71%

 Control mean 59%

 Both sutures>94% “very 

good” or “excellent”

Not statistically significant

Specific:

Excellent

 Intervention mean 75%

 Control mean 62%

 Both sutures>94% “very 

good” or “excellent”

Not statistically significant

Pain Day 1

evaluation:

1-2 days: 

 Intervention: 88

 Control:45

14 days:

 Intervention: 91

 Control:44

80 days

 Intervention: 76

 Control:38

Follow-up: Wound 

healing was 

evaluated at 

follow-up visits at 

1-2 days, 14 (±2) 

days and 80 (±5) 

days postimplantation.
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and should not be construed to represent any agency determination or policy. 123

Author

Year

(Data 

Extractor)

Study 

Design

Quality 

Score

Study Objective Population and Setting Intervention Results Comments

study; or allergy to 

triclosan.

 Intervention: 68%

 Control: 89%

 P=0.01

Pain Day 14

 Intervention: 12%

 Control: 9%

Pain Day 80

 Intervention: 3%

 Control: 0%

Reoperations:

Adverse events requiring 

surgery

 Intervention: 17 (17%)

 Control: 10 (20%)

Length of stay: NR

Mortality: NR

Adverse events:

The most common events 

consisted of admissions 

for chemotherapy.

Any Adverse Events:

 Intervention: 17 (17%)

 Control: 10 (20%)

Severe Adverse Events:

 Intervention: 1 (1%)

 Control: 1 (2%)

Serious Adverse Events:

 Intervention: 13 (13%)

 Control: 8 (16%)

Day 1 Antimicrobials

received:

Intervention: 24%

Control: 31%

Day 14 Antimicrobials

received:

 Intervention: 13%
Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminated by the Centers for Disease Control and Prevention 

and should not be construed to represent any agency determination or policy. 124

Author

Year

(Data 

Extractor)

Study 

Design

Quality 

Score

Study Objective Population and Setting Intervention Results Comments

 Control: 23%

Day 80 Antimicrobials

received:

 Intervention: 22%

 Control: 29%

Received other medications 

that could impede wound 

healing:

Day 1

 Intervention: 10%

 Control: 13% (not 

significant)

Day 14

 Intervention: 14%

 Control: 14%

Day 80

 Intervention: 12%

 Control: 21%

Suture sinus: none

D. How safe and effective are antimicrobial dressings applied to surgical incisions following primary closure in the 

operating room? Our research did not identify RCTs that evaluated the safety and effectiveness of antimicrobial dressings 

(i.e., iodine, silver, or other antimicrobial ointment impregnated dressing) applied to surgical incisions closed primarily in the 

OR (i.e., the skin edges are re-approximated at the end of the operation) and their impact on the risk of SSI.
Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminated by the Centers for Disease Control and Prevention 

and should not be construed to represent any agency determination or policy. 125

RISK OF BIAS ASSESSMENTS OF STUDIES Q2

Systematic Reviews

Author

Year (RefID)

KQ Search 

terms 

described

Databases 

described 

and two 

or more 

databases 

searched

Inclusion/ 

exclusion 

criteria 

described

Number of 

included/ 

excluded 

studies along 

with reasons 

of exclusion 

described

Studies 

screened 

by two 

independent 

reviewers 

for inclusion

Data 

extracted 

by two 

independent 

reviewers

Individual 

study 

quality 

assessed

Heterogeneity 

between study 

results assessed 

qualitatively 

and/or 

quantitatively

Publication 

bias 

assessed

Characteristics 

of included 

studies 

reported in 

evidence table

Funding 

source(s) 

disclosed 

and no 

obvious 

conflict of 

interest

Overall 

Risk of 

Bias

Question 2: Non-Parenteral Antimicrobial Prophylaxis

Charalambous

2003 45 2         Low

Randomized Controlled Trials

Author

Year (RefID)

KQ Described 

as 

randomized

Randomization 

appropriately 

performed

Described 

as doubleblind

Outcome 

assessor 

blinded

Study 

participant 

blinded

Investigator 

blinded

Attrition 

described

Attrition smaller 

than 10-15% of 

assigned patients

Attrition 

appropriately 

analyzed

Funding source(s) 

disclosed and no 

obvious conflict of 

interest

Overall 

Risk of 

Bias

Question 2: Non-Parenteral Antimicrobial Prophylaxis

Almdahl

2011 48 2      Low

Ford

2005 53 2       Low

Kamath

2005 46 2       Low

Litmathe

2009 50 2     Moderate

Mingmalairak

2009 51 2           Low

Neri

2008 47 2     Moderate

Peerbooms

2009 49 2         Low

Rozzelle

2008 52 2           Low

Zhang

2011 54 2         Low
Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminated by the Centers for Disease Control and Prevention 

and should not be construed to represent any agency determination or policy. 126

Q3 GLYCEMIC CONTROL 

GRADE TABLE Q3

Comparison Outcome

Quantity 

and Type of 

Evidence

Findings

Startin

g 

GRADE

Decrease GRADE Increase 

GRADE

GRADE of 

Evidence 

for 

Outcome

Overall 

GRADE of 

Evidence 

Base

Study Quality

Consistency

Directness

Precision

Publication Bias

Large Magnitude

Dose-response

Confounders

Q3. How do perioperative blood glucose and hemoglobin A1C levels impact the risk of SSI and what are their optimal perioperative target levels in diabetic and non-diabetic 

patients?

Strict 

glycemic 

control vs. 

standard 

glycemic 

control

SSI* 2 RCT 55,56

 Two RCTs in 480 cardiac surgery predominantly 

non-diabetic (70%-80%) populations. Glycemic 

control protocol instituted intraoperative and 

postoperatively in the SICU for 24-36 hours. Both 

RCTs report a primary composite outcome 

variable that includes SSI (underpowered to detect 

differences in individual outcomes).

 1 large 55 (N=371) and one small 56 (N=109) RCT, 

comparing strict (80-100mg/dL) to standard 

(<200mg/dL) glycemic control found no difference 

in either the composite outcome variable which 

included SSI: RR 1.0, (95% CI, 0.8-1.2); p=0.71 

(adjusted OR: 0.09 (95% CI, 0.6-1.4; p=0.68)or in 

deep sternal SSIs: RR 0.9 (95%CI, 0.3-2.5); p=0.79. 

In subanalyses of separate diabetic (n=73) and 

non-diabetic (n=298) populations, no difference 

was noted between groups for either the 

composite (p=0.40) or deep sternal SSI (p=0.61) 

variables. The study could not examine whether 

outcomes differed by diabetes status.

 1 small RCT 56 (N=109), comparing strict (80-

130mg/dL) to standard (160-200mg/dL) glycemic 

control found no difference in either the 

composite infection outcome variable: 19.2% vs. 

High 0 0 -1 0 0 0 0 0

Moderate Moderate
Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminated by the Centers for Disease Control and Prevention 

and should not be construed to represent any agency determination or policy. 127

Comparison Outcome

Quantity 

and Type of 

Evidence

Findings

Startin

g 

GRADE

Decrease GRADE Increase 

GRADE

GRADE of 

Evidence 

for 

Outcome

Overall 

GRADE of 

Evidence 

Base

Study Quality

Consistency

Directness

Precision

Publication Bias

Large Magnitude

Dose-response

Confounders

35.3%; p=0.12.and no difference in SSIs: 11.1% vs. 

16.7%; p=0.09.

Hypoglycemia* 2 RCT 55,56

 1 large RCT 55 defined hypoglycemia as <60mg/dL, 

reported it as number of episodes in each 

treatment group. While the study found no 

difference between groups for hypoglycemic 

episodes in the SICU, it did find that for both 

groups a higher proportion of the episodes 

occurred in the SICU: 8(4%) vs. 14(8%); p=1.00, RR 

1.01 (95%CI, 0.06-15.95) as compared to 

intraoperatively: 1(1%) vs. 1(1%); p=0.192, RR 1.76 

(95% CI, 0.76-4.09). 

 1 small RCT 56 defined hypoglycemia as <50mg/dL 

and reported it as the ratio of hypoglycemic 

episodes per number of glucose measurements. It 

also noted no difference between groups for 

hypoglycemic episodes: 2.9% vs. 2.1%, (95% CI, 

0.84-1.43); P=0.67. 

 Neither study reported clinical complications 

resulting from hypoglycemia.

High 0 0 0 0 0 0 0 0

High

Mortality 1 RCT 55

 Mortality was rare, reported only in the strict 

glycemic control group, and not associated with 

blood glucose target levels: 4/185 vs. 0/186.

High 0 0 0 -1 0 0 0 0 Moderate

Length of 

stay

1 RCT 55

 Length of hospital stay (p=0.66) and length of SICU 

stay (p=0.37) were not associated with blood 

glucose targets.

High 0 0 0 -1 0 0 0 0 Moderate

*Critical outcome; OR: Odds Ratio; RR: Risk Ratio; CI: Confidence Interval
Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminated by the Centers for Disease Control and Prevention 

and should not be construed to represent any agency determination or policy. 128
Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminated by the Centers for Disease Control and Prevention 

and should not be construed to represent any agency determination or policy. 129

EVIDENCE TABLE Q3

Q3. How do perioperative blood glucose and hemoglobin A1C levels impact the risk of SSI and what are their optimal 

perioperative target levels in diabetic and non-diabetic patients?

Author

Year

(Data 

Extractor)

Risk of Bias 

Score

Study 

Objective

Population and Setting

(N) Intervention Results Comments

Chan

2009 56

(ES)

RCT

1, 5, 7, 10

To investigate 

whether 

different 

targets of 

intraoperative 

and 

postoperative 

glucose (80-

130 mg/dl, 

4.4-7.2 mEq/l 

or 160-200 

mg/dl, 8.8-

11.1 mEq/l) 

could affect 

postoperative 

clinical 

outcomes 

after cardiac 

surgery with 

cardiopulmon

ary bypass.

Number of patients: N=109

Patient Characteristics: the 

groups were comparable 

with respect to age, 

gender and height.

·Age

·Gender

·Obesity: BMI

 Intervention: 24 (±3.4)

 Control: 26 (±4.9)

·Comorbidities:

ASA status P4:

 Intervention: 70.2%

 Control: 86.3%

Length of CBP (min)

 Intervention: 97.9 (±45.3)

 Control: 116.3 (±54)

 P=0.060

Procedures: Open-heart 

surgery requiring 

cardiopulmonary bypass 

(CBP). 

Indications: NR

Setting: 1 university hospital

Location: Brazil

Dates: NR (over a period of 

12 months)

Inclusion Criteria: adults 

from both genders who 

were older than 21 years 

of age and who were 

undergoing open-heart 

Intervention group (intensive) 

n=54

Intervention: 80 -130mg/dL 

glucose

Timing of intervention: 

perioperative

Duration of intervention: from 

arrival in OR until36h postop

Device/agent: Glucose

Monitoring intervention: 

Measurements of whole blood 

glucose in undiluted arterial 

blood every 1-4h using a 

glucose analyzer. Glucose 

dose was adjusted by ICU 

nurses according to a titration 

algorithm (Leuven modified). 

algorithm given as guidance 

rather than exact targets

Control group: (less intensive) 

n=55

 Control: 160-200mg/dL glucose

Standard preventive measures: 

AMP: 2nd generation 

cephalosporin

Transfusion threshold: 

hematocrit<30%

SSI 

Intervention: 11.1% 

Control: 16.7%

P=0.09

Other infections: NR

Topic-specific outcomes:

Hypoglycemia

Reported as: hypoglycemic episodes 

per number of glucose 

measurements

2.9% vs. 2.1% P=0.67 (0.84-1.43)

Reoperations: NR

Length of stay: (days)

 Intervention: 12 (±7)

 Control: 17 (±16)

 P= 0.060 (0.24-1.01)

Mortality: (%)

 Intervention: 6.4%

 Control: 5.9%

Adverse events: 

No clinical complications reported 

resulting from hypoglycemia at 

follow up (30 days).

Definitions:

Hypoglycemia: Defined as 

<50mg/dL

Perioperative care: parenteral 

care was not prescribed for 

any patients in the study.

Other notes: authors indicate 

that 11 patients were lost to 

follow up and “may have 

biased the results” AND “this 

pilot study sample size was 

not large enough to allow for 

any definite conclusions or 

recommendations on the 

effect of strict glucose 

control vs. less intensive 

control”

Follow-up: 30 days
Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminated by the Centers for Disease Control and Prevention 

and should not be construed to represent any agency determination or policy. 130

Author

Year

(Data 

Extractor)

Risk of Bias 

Score

Study 

Objective

Population and Setting

(N) Intervention Results Comments

cardiac surgery requiring 

CBP.

Exclusion Criteria: (1) renal 

failure 

(creatinine>1.5g/dl), (2) 

neurological dysfunction 

(diagnosis from medical 

records), (3) chronic 

pulmonary obstructive 

disease (COPD), (4) 

current use of any type of 

antimicrobial, (5) current 

use of inotropic support, 

(6) emergency and urgent 

surgeries, and (7) 

reoperations.

Ghandi

2007 55

(ES)

RCT

1, 4, 5, 7, 8

To determine 

whether 

maintenance 

of near 

normoglycemi

a during 

cardiac 

surgery by 

using 

intraoperative 

intravenous 

insulin 

infusion 

reduced 

perioperative 

death and 

morbidity 

when added 

to rigorous 

Number of patients N=371

Patient Characteristics: 

Baseline characteristics 

did not differ statistically 

significantly between 

groups.

·Age

·Gender

·Obesity

·Comorbidities:

20% had known diabetes

Procedures: 

Cardiopulmonary bypass 

surgery

Indications: NR

Setting: 1 tertiary care 

teaching hospital

Location: USA

Intervention group: n=185

Intraoperative glycemic control 

of 80mg/dL – 100mg/dL 

(4.4mmol/L – 5.6 mmol/L)

Timing of intervention: 

intraoperative

Duration of intervention: 

intraoperative only

Device/agent: Glucose

Monitoring intervention: 

Arterial blood glucose levels 

were measured with a 

glucometer.

Control group: n=186

Intraoperative glycemic control 

target of <200mg/dL 

(11.1mmol/L) if glucose level 

reached >250mg/dL 

SSI 

Composite primary outcome

Intervention: 6/185 (3%) 

Control: 7/186 (4%) 

OR: 0.9, 95%CI (0.3-2.5) 

P=0.79

Other infections: NR

Topic-specific outcomes: 

Hypoglycemia

Intraoperative (1 patient in each 

group) 

 RR 1.01 (95%CI 0.06-15.95)

Postoperative (ICU): 

Intervention: 14 (8%)

Control: 8(4%)

RR 1.76 (95% CI 0.76-4.09)

All mild without adverse 

consequences

Definitions:

Primary outcome = composite 

of death, sternal wound 

infections, prolonged 

pulmonary ventilation, 

cardiac arrhythmias, stroke, 

and acute renal failure within 

30 days postop.

Hypoglycemia: glucose 

<60mg/dL;

Perioperative care : NR 

Other notes: this single center 

study used a composite end 

point and could not examine 

whether outcomes differed 

by diabetes status.

Primary outcome variable was 

a composite variable because 

“not feasible to power study 
Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminated by the Centers for Disease Control and Prevention 

and should not be construed to represent any agency determination or policy. 131

Author

Year

(Data 

Extractor)

Risk of Bias 

Score

Study 

Objective

Population and Setting

(N) Intervention Results Comments

postoperative 

glycemic 

control.

Dates July 2004 – April 2005

Inclusion Criteria: Adults 

undergoing elective 

cardiac surgery during 

study dates

Exclusion Criteria: Patients 

who had off-pump 

cardiopulmonary bypass 

procedures.

(13.9mmol/L), then 

intraoperative bolus was given 

until level was less than 

150mg/dL (8.3mmol/L)

Standard preventive measures: 

Both groups had strict 

postoperative glycemic 

control of 80mg/dL –

100mg/dL)

Reoperations: NR

Length of stay: 

median and mean LOS in hospital 

and ICU P=-.66 and p=0.37

Mortality: 

Overall& In hospital 

4/185 (2%) vs. 0%

Post discharge (up to 30d postop) 

0% vs. 0%; P=0.061

NOTE: POST DISCHARGE F/U in only 

4% vs. 5% of patients

Adverse events: None reported

to detect differences in 

individual components such 

as death, because the rare 

occurrences would mandate 

a very large sample size.”

Follow-up: 30 days
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and should not be construed to represent any agency determination or policy. 132

RISK OF BIAS ASSESSMENTS OF STUDIES Q3

Randomized Controlled Trials

Author

Year (RefID)

KQ Described 

as 

randomized

Randomization 

appropriately 

performed

Described 

as doubleblind

Outcome 

assessor 

blinded

Study 

participant 

blinded

Investigator 

blinded

Attrition 

described

Attrition smaller 

than 10-15% of 

assigned patients

Attrition 

appropriately 

analyzed

Funding source(s) 

disclosed and no 

obvious conflict of

interest

Overall 

Risk of 

Bias

Question 3: Glycemic Control

Chan

2009 56 3     Moderate

Gandhi

2007 55 3      Low
Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminated by the Centers for Disease Control and Prevention 

and should not be construed to represent any agency determination or policy. 133

Q4-5 NORMOTHERMIA 

GRADE TABLE Q4-5

Comparison Outcome

Quantity 

and Type of 

Evidence

Findings Starting 

GRADE

Decrease GRADE Increase 

GRADE

GRADE of 

Evidence 

for 

Outcome

Overall 

GRADE of 

Evidence 

Base

Study Quality

Consistency

Directness

Precision

Publication Bias

Large Magnitude

Dose-response

Confounders

Q4. How safe and effective is the maintenance of perioperative normothermia in reducing the risk of SSI? 

Warming vs. 

no warming

Surgical site 

infection* 2 RCT 57, 58

 Meta-analysis of 2 RCT (N=616) found that 

maintenance of normothermia associated 

with reduced risk for SSI (OR: 0.29; 95% CI: 

0.16 – 0.53; p<0.0001)

 Mixed surgical populations, multiple warming 

techniques

 Maintenance of perioperative normothermia 

with warming techniques associated with 

reduced risk of surgical site infection 

 1 RCT 57 in 416 patients undergoing elective 

hernia repair, varicose vein and breast 

surgery, preoperative systemic warming only : 

13/277 (5%) vs. 19/139 (14%); P=0.001 at 2-6 

week follow up

 1 RCT 58 in 200 elective colorectal surgery 

patients using intraoperatively only warming: 

6/104 (6%) vs. 18/96 (19%); P=0.009 at 2 

week follow up.

High 0 0 0 0 0 0 0 0 High

High

ASEPSIS 

score

2 RCT 57,

58

 ASEPSIS wound scores were higher in control 

groups (p=0.007 57 and p=0.002 58)

 In a meta-analysis of the two studies, warmed 

patients were less likely to have ASEPSIS 

wound scores >20 (Relative Risk: 0.19; (95% CI, 

0.09 – 0.39); p<0.0001

High 0 0 0 0 0 0 0 0 High
Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminated by the Centers for Disease Control and Prevention 

and should not be construed to represent any agency determination or policy. 134

Comparison Outcome

Quantity 

and Type of 

Evidence

Findings Starting 

GRADE

Decrease GRADE Increase 

GRADE

GRADE of 

Evidence 

for 

Outcome

Overall 

GRADE of 

Evidence 

Base

Study Quality

Consistency

Directness

Precision

Publication Bias

Large Magnitude

Dose-response

Confounders

Mortality,

30 days 1 RCT 58

 Mortality within 30 days was rare (4 deaths in 

200 patients), with no difference observed 

between groups

High 0 0 0 -1 0 0 0 0 Moderate

Blood loss 1 RCT 58

 Normothermia associated with lower mean 

units of blood transfused per patient: 0.4±1.0 

vs. 0.8±1.2; p=0.01]) and fewer patients 

transfused: 23/104 (22%) vs. 34/96 (35%)

High 0 0 0 -1 0 0 0 0 Moderate

Core 

temperature

2 RCT 57,58

 1 RCT 57 found that core temperature was 

increased by either local or systemic warming 

techniques, delivered pre-operatively for 30 

minutes. The impact of systemic warming 

(mean increase: 0.350 C; p=0.001) was greater 

than local warming (mean increase: 0.130 C; 

p=0.028). The mean core temperature after 

surgery was within normal limits.

 1 RCT58 found that core temperature at end 

of surgery was increased with intraoperative 

systemic warming (p<0.001), and remained 

higher for more than 5 hours following 

surgery

High 0 0 0 0 0 0 0 0 High

Length of 

hospital stay 1 RCT 58

 Normothermia associated with reduced length 

of stay (net reduction: 2.6 days; p=0.001); 

difference remained when analysis was limited 

to uninfected patients

High 0 0 0 -1 0 0 0 0 Moderate

Duration of 

surgery

2 RCT 57,58  Normothermia not associated with increased 

duration of surgery High 0 0 0 0 0 0 0 0 High

Warming: 

perioperative(car

bon polymer 

mattress [2hours 

Surgical site 

infection* 1 RCT 59

 Perioperative warming associated with 

decreased incidence of SSI (12.8% vs. 26.8%), 

but this finding was not significant OR 0.4 

(95% CI, 0.14-1.13); p=0.08; sample size based 

High 0 0 0 -1 0 0 0 0 Moderate Moderate
Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminated by the Centers for Disease Control and Prevention 

and should not be construed to represent any agency determination or policy. 135

Comparison Outcome

Quantity 

and Type of 

Evidence

Findings Starting 

GRADE

Decrease GRADE Increase 

GRADE

GRADE of 

Evidence 

for 

Outcome

Overall 

GRADE of 

Evidence 

Base

Study Quality

Consistency

Directness

Precision

Publication Bias

Large Magnitude

Dose-response

Confounders

preop, intraop, 

and 2 hours 

postop], forced 

air warming and 

fluid warmer 

intraop) 

vs. 

intraoperative 

only (carbon 

polymer mattress, 

forced air 

warming and fluid 

warmer)

on all complications

Mortality 1 RCT 59  3 deaths in 103 patients, with no difference 

observed between groups High 0 0 0 -1 0 0 0 0 Moderate

Blood loss 1 RCT 59  Perioperative warming associated with lower 

blood loss (p=0.011) High 0 0 0 -1 0 0 0 0 Moderate

Core 

temperature

1 RCT 59

 Perioperative systemic warming group, higher 

core temperature achieved immediately after 

2 hours of preoperative warming (p=0.001)

 Perioperative systemic warming group 

maintained higher core temperature during 

the first 90 minutes of surgery (median 36.2 

vs. 36.1) but not at 2 hours postoperatively 

(p=0.471)

High 0 0 0 -1 0 0 0 0 Moderate

Length of 

hospital stay 1 RCT 59  Perioperative warming not associated with 

reduced length of hospital stay (p=0.217) High 0 0 0 -1 0 0 0 0 Moderate

Duration of 

surgery

1 RCT 59

 Perioperative systemic warming was not 

associated with increased duration of surgery 

(p=0.150)

High 0 0 0 -1 0 0 0 0 Moderate

*Critical outcome; OR: Odds Ratio; RR: Risk Ratio; CI: Confidence Interval
Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminated by the Centers for Disease Control and Prevention 

and should not be construed to represent any agency determination or policy. 136

EVIDENCE TABLE Q4-5

Q4. How safe and effective is the maintenance of perioperative normothermia in reducing the risk of SSI? 

Author

Year

(Data 

Extractor)

Risk of Bias 

Score Study Objective Population and Setting (N) Intervention Results Comments

Wong

2007 59

(SIBT)

RCT

1, 2, 4, 6, 7,

8, 9

To examine the 

effects of 

extending 

systemic 

warming 

duration to 

include preand 

postoperative 

periods and the 

potential 

benefits in 

reducing 

postoperative 

complications 

in patients 

undergoing 

elective major 

abdominal 

surgery..

No. patients: N=103 

Patient 

Characteristics: (age, 

sex, ASA score, MBI, 

POSSUM scores, 

baseline temperature, 

pulse rate and mean 

arterial pressure were 

similar in both 

groups/not 

statistically significant 

except for core 

temperature before 

start of surgery (see 

results)

Age: ≥ 18years of age

Median (range)

Intervention:62.0 (24-

88)

Control: 60.5 (20-84)

Gender: m/f

Intervention: 24/23

Control: 29/27

BMI: median (range)

Intervention: 

23.0(15.5-39.2)

Control:

25.0 (16.5-36.3)

ASA score

ASA1:29/103 (28.2%)

ASA2: 50/103 (38.5%)

ASA3:24/103 (23.3%)

More than 75% of 

Intervention: n=47

Mattress warmed to 40°C 

2 hours before surgery, 

during surgery, and for 2 

hours after surgery in 

addition to standard 

practice of systemic 

warming with forced air 

warming device set at 40°C 

and with a fluid warmer

Timing of Intervention: 

pre, intra and post 

operatively.

Duration of intervention : 

2h preoperatively, 

intraoperatively and 2 

hours post operatively

Device: conductive carbon 

polymer mattress can 

provide sustained heat up 

to 40°C.

Monitoring:

Pre and postoperatively: 

before and immediately 

after surgery tympanic 

thermometer

Intraoperative:

nasopharyngeal 

temperature probe (every 

30 minutes)

Control: n=56

Mattress warmed to 40°C 

only during surgery in 

SSI

Intervention: 6/47(12.8%) 

Control: 15/56 (26.8%) 

Other Infections

Chest infection

Intervention: 2/47 (4.3%)

Control: 6/56 (10.7%)

Urinary tract infection:

Intervention: 3/47 (6.4%)

Control: 2/56 (3.6%)

Topic specific outcomes

median (range) ; P value

Core Temperature Immediately 

after preoperative systemic 

warming: 

Intervention 36.4 (35.1-37.4)

Control: 36.0 (35.1-36.9) 

P <0.001

Intraoperative: 90 minutes

Interventions group “maintained 

a significantly higher temperature 

during the first 90 minutes of 

surgery” (median 36.2) vs. 

controls (36.1). 

Core Temperature Postop 

(2hours): 

Intervention: 36.3 (34.3-38.1)

Control: 36.2 (34.3-37.9) 

P=0.471

Blood loss (ml): Mean (range)

Intervention: 200 (5-1000) 

Control: 400 (50-2300)

P=0.011

Definitions: 

SSI- CDC: (1) when pus could be 

expressed from the surgical 

incision or aspirated from a 

loculated mass inside the wound 

(2) if the pus culture was 

positive for pathogenic bacteria 

(3) if there was localized 

tenderness, localized swelling, 

redness or temperature at the 

surgical site, or (4) if the treating 

medical practitioners had 

diagnosed them as infected and 

treated them with 

antimicrobials.

Hypothermia: <36°C

Normothermia: ≥36°C

Perioperative care:

Anesthesia: Fentanyl and 

vecoronium bromide. Isoflurane 

(in 60% nitrous oxide) titrated to 

maintain MAP within 20% of 

pre-induction values. Additional 

fentanyl at end to improve 

analgesia.

Other notes: NR

Follow up: every day during 

hospitalization and at 6-8 weeks 

postoperatively (usually in the 

home)
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and should not be construed to represent any agency determination or policy. 137

procedures performed 

by consultant (senior) 

surgeon

Procedure: Elective 

major abdominal 

surgery

Right hemicolectomy 

n=31

Anterior resection 

n=24

Indications:

Colorectal cancer 

n=71 Inflammatory 

bowel disease n=15

Diverticular disease 

n=7 Gastric carcinoma 

n=3 Benign colonic 

tumor n=2 Others n=5

Setting: 1 university 

hospital

Location: United 

Kingdom

Dates: October 2002 

to December 2003

Inclusion criteria: 

major open abdominal 

surgery requiring 

bowel resection, with 

or without 

anastomosis

Exclusion criteria: 

laparoscopic 

procedures, use of 

corticosteroids or 

other 

immunosuppressive 

drugs (including 

cancer 

chemotherapy_ 

during the 4 weeks 

addition to standard 

practice of systemic 

warming with forced air 

warming device set at 40°C 

and with a fluid warmer

Standard Preventive 

Measures

AMP- not described

AMP duration: mean 

(range)

Intervention:1 (0-28)

Control: 2(0-12)

P=0.200

Bowel Prep-not described

All other outcome variables (IV 

fluids, urine output, blood 

transfusion units (none), duration 

of antimicrobials, flatus passed, 

bowels opened, diet tolerated, 

duration of hospital stay and 

follow up) showed no statistically 

significant difference

Reoperations: NR

Length of Stay: mean (range); P 

value

Intervention: 11.0 (5-119)

Control: 9.0 (5-40)

P value 0.217

Mortality- 1 (surgical 

emphysema from intubation 

complication) vs. 2 (renal & 

respiratory failure) (P=0.566)

Adverse events: 

Total Number of Adverse events:

Intervention: 15/47 (32%)

Control: 30/56 (54%)

P=0.027

Ileus 7/103 (14.9%)

Pelvic collection 3/103 (2.9%)

Cardiac complications 2/47 

(4.3%)

Renal Failure 2/47(4.3%)

Anesthetic complications 

1/47(2.1%)

Clostridium difficile diarrhea 

1/47(2.1%)

Pressure ulcer 1/47(2.1%)

For SSI, chest infection and 

urinary tract infection see “Other 

Infections” above

.
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before surgery, recent 

history of fever, 

infection or both, 

serious malnutrition 

(serum albumin 

<3.3g.dl, a white cell 

count <2500 cells per 

ml or the loss of more 

than 20% of body 

weight within 3 

months of surgery) 

and bowel 

obstruction.

Melling

200157

(SIBT)

RCT

1, 2, 4, 6, 7, 

8, 9

To assess the 

use of a local 

warming device 

and a warm air 

blanket for the 

reduction of 

infection after 

clean wound 

surgery.

No. patients: N= 416 

Patient 

characteristics: similar 

in all groups. Including 

age, BMI, gender, 

fasting>8h, hair 

removal (shaving) >6 

h, type of surgery, 

surgery in last 3 

months, cancer 

diagnosis, initial core 

temperature, AMP, 

length of surgery, 

seniority of surgeon.

Age, years: ≥18 years 

Mean (SD)

Intervention 

1:49.7(13.7)

Intervention 2: 50 

(14.1)

Control: 50.4 (15.3)

Gender m/f: 174/242

BMI:

Intervention 

1:25.7(4.3)

Intervention 

2:25.8(4.1)

Intervention1-Systemic 

n=139 group-standard 

preoperative care plus 

minimum 30 minutes 

preoperative warming to 

the whole body using 

forced-air, warming 

blanket.

Intervention 2- Local 

n=138 standard 

preoperative care plus 

minimum 30 minutes 

preoperative warming to 

just the planned wound 

area using a non-contact, 

radiant heat dressing.

Timing of intervention: 

preoperative

Duration of Intervention: 

for a minimum of 30 

minutes until just before 

surgery

Device: 

Systemic-Forced-air 

warming blanket

Local- non-contact, radiant 

heat dressing.

SSI : 2-6 weeks

Overall rate of infection 32/416 

(8%)

SSI:

Interventions1&2 13/277 (5%)

Control: 19/139(14%) 

P=0.001

ASEPSIS wound scores

significantly higher in control 

group vs. combined interventions 

(p=0.007)

ASEPSIS >20

Interventions 1&2 10/277 (4%)

Control: 17/138 (12%)

Other wound complications 

including hematoma, seroma, 

and wound aspiration no 

statistically significant difference 

between groups.

SSI : Intervention 2 -local vs. 

Intervention 1-systemic warming

No differences in outcomes 

between two warming methods.

Individually both local (p=0.003) 

and systemic (p=0.026) warming 

had a significant effect on rate of 

Definitions: 

SSI- purulent discharge or a 

painful erythema that lasted 5 

days and was treated with 

antimicrobials within 6 weeks of 

surgery. Wounds were swabbed 

for culture if purulent discharge 

present at time of review.

Note: only 14 wound swabs 

were obtained because 

Postoperative antimicrobials-

“Patients seen at 2 and 6 weeks 

had often been prescribed 

antimicrobial treatment by their 

general practitioner without 

having wound swabbed”

Normothermia: NR

Hypothermia: NR

Perioperative care:

Anesthesia- not described

Hair Removal- Shaving

No shaving 110/416(26.4%)

Shaving <7h preop: 116/416 

(27.9%)

Shaving>7h preop: 183/416 

(20%)

Info missing n = 9
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Control:25.6(4.1)

Procedure: Elective 

hernia repair n=155 

varicose vein surgery 

n=86 breast surgery 

n=175

Indications: NR 

Setting: 1 district 

general hospital

Location: United 

Kingdom

Dates: April 1999 to 

May 2000

Inclusion criteria: 

Elective hernia repair, 

varicose vein surgery, 

or breast surgery that 

would result in a scar 

longer than 3 cm in 

length.

Exclusion criteria: 

Pregnant, taking longterm oral steroids, had 

received radiotherapy 

( to the incision site) 

or chemotherapy in 

the last 4 weeks, or 

had an infection at the 

time of surgery

Monitoring intervention: 

tympanic thermometers 

before any treatment, 

after any warming and 

after surgery

Control: - (n=139) 

standard preoperative 

care plus no warming

Standard Preventive 

Measures:

Antimicrobial prophylaxisAMP: 119/416 (29%) 

SSI.

Effect of warming interventions 

compared with control:

Absolute risk reduction (95% CI):

Intervention 1 systemic 

10.1% (3.6-16.6)

Intervention 2 Local 

7.9% (1.0-14.8) 

Relative risk reduction: 

Intervention 1 systemic 73.7%

Intervention 2 local 57.7% 

Numbers needed to treat: 

Intervention 1 systemic 15 

patients. 

Intervention 2 local 10 

SSI vs. No SSI

Mean (SD)

Stepwise logistic regression 

yielded only body mass index as 

significant variable at the 5% 

level OR 1.12 (95% CI 1.02-1.21)

BMI

SSI: 28.04 (4.44)

No SSI 25.31(3.98)

Breast surgery had higher SSI rate 

than hernia repair and varicose 

veins

Hair Removal: 

No shaving: 

SSI 9/32 (28%)

No SSI 101/384 (27%) 

Shaving within 7h of surgery

SSI 6/32 (19%)

No SSI 110/384 (30%) 

Shaving >7hrs before surgery

SSI 17/32 (53%) 

No SSI 166/384 (44%) 

SSI and AMP:

Had AMP

SSI: 6/32 (19%)

Follow up: 2-6 weeks 

postoperatively in outpatient 

clinic or home. Direct 

observation, patient diary, if not 

available for examination then 

telephone assessment patient 

questionnaire (6/10 

questionnaires returned)
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No SSI 115/384 (30%) 

Topic-specific outcomes

mean (SD); P value

Initial core temperatures were 

significantly increased by 

intervention 1 and 2 vs. control

Intervention 1Systemic 

0.35°C(0.58)

P=0.001

Intervention 2 Local: 0.13°C( 

0.57)

P=0.028 Control initial core temp: 

36.5 (0.55)

Postoperative core temperatures

were within normal limits: 36.41 

(0.59)

Intervention 2-Local received 

longer period of warming (min) 

as compared to Intervention 1-

systemic (44.94 vs. 38.73, 

p=0.005)

Length of stay: NR

Mortality: NR

Adverse events: 

Prescribed postop 

antimicrobials: Intervention1&2: 

18/277(7%)

Control: 22/139 (16%)

P=0.002

Kurz

1996 58

(SIBT)

RCT

1, 2, 4, 5, 6, 

7, 8, 9

To test 

hypothesis that 

hypothermia 

both increases 

susceptibility to 

surgical wound 

infection and 

lengthens 

hospitalization

No. patients: N=200 

Patient 

Characteristics:

characteristics, 

diagnoses, types of 

surgical procedure, 

duration of surgery, 

hemodynamic values, 

and types of 

anesthesia were 

Intervention: n=104

Fluid warmer on.

Forced-air cover 40°C 

Patient target core temp

maintain near 36.5°C

Timing of Intervention: 

intra-operative

Duration of intervention: 

intraoperative ( from 

induction of anesthesia to 

SSI: 2 weeks

Overall: 24/200 (12%)

Intervention: 6/104 (6%)

Control: 18/96 (19%) 

P=0.009

SSI in smokers(n=62) vs. nonsmokers (n=138)

Smokers: 14/62 (23%) 

Non-smokers10/138 (7%)

P=0.004

Definitions

Wound Infection (Suspected): If 

pus could be expressed from the 

surgical incision or aspirated 

from a loculated mass inside the 

wound 

Wound Infection (Confirmed) - if 

pus culture was positive for 

pathogenic bacteria. 

ASPESIS score >20 
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similar in both groups 

-no statistically 

significant difference 

Age: 18 to 80 years

mean±SD

Age: 

Gender: m/f 108/92

Height ,cm:

Intervention:170±9

Control: 169±9

P=0.43

Weight, kg

Intervention:73±14

Control: 71±14

P=0.31

Procedure: Elective 

colorectal resection

Indication:

Cancer 182/200 (91%) 

Inflammatory bowel 

disease 18/200 (9%)

Setting: 3 hospitals 

1 University n=155 

1 University n=30 

1 other hospital n=15

Location: Austria

Dates: July 1993 

through March 1995

Inclusion criteria: 

Abdominal 

intraperitoneal pullthrough procedures

Exclusion criteria: 

minor colon surgery 

(e.g., polypectomy or 

colostomy performed 

as the only

procedure), use of 

corticosteroids or 

other 

end of surgery)

Device:

Fluid warmer and

forced-air cover 

Monitoring: 

Temperature: tympanic 

thermometer 

Preop- recorded

Intraop- 10 min intervals

Postop-20 min intervals for 

6h

Thermal comfort-visual 

analog scale (VAS)

Pain- VAS

Shivering-scale all 

evaluated at 20min 

intervals for 6 hours 

postop.

Control: n=96

Fluid warmer off.

Forced-air cover ambient 

temperature 

Patient target core temp: 

allowed to decrease to 

~34.5°C.

Standard preventive 

measures: 

Bowel Prep- standard 

mechanical bowel prep 

with an electrolyte 

solution.

AMP-standardized- IV 

cefamandole and 

metronidazole at induction 

of anesthesia and 

maintained for 4 days 

postoperatively

Fluids: “hydrated 

aggressively during and 

after surgery” – see details

SENIC score (1/2/3)

Intervention:3/95/6

Control:3/88/5

NNISS scores (0/1/2)

Intervention:32/49/23

Control:31/39/26

P=0.6

ASEPSIS scores:

Intervention: 7±10

Control: 13±16 

P=0.002

ASEPSIS scores>20: 

Intervention: 6% of patients

Control: 32% of patients

P<0.001

ASEPSIS Score in smokers(n=62) 

vs. non-smokers (n=138)

Smokers:15±18 

Non-smokers: 8±10

P<0.001

SSI Risk Factors, multivariate 

analysis

OR (95%CI)

Tobacco use (Y/N): 10.5 (3.2-

34.1)

Group assignment (Intervention 

vs. Control)

4.9 (1.7-14.5)

Surgical site (rectum vs. colon)

2.7 (0.9-7.6)

NNISS score (per unit increase)

2.5 (1.2-5.3)

Age (per decade) 1.6 (1.0-2.4)

Other infections:

Topic-specific outcomes:

mean ± SD; P value: 

Intraoperative

Transfusions (allogeneic blood) 

Intervention: 0.4±1.0

Control 0.8 ± 1.2

Hypothermia 34.5°C

Normothermia 36.5°C

Perioperative care:

Anesthesia standardized: 

thiopental sodium, fentanyl, 

vecuronium bromide, isoflurane, 

and fentanyl at completion for 

analgesia.

Follow up: 2 weeks: daily in 

hospital and at 2 weeks postop. 

94% returned for 2 week visit, 

those who did not were evenly 

distributed between the study 

groups and most returned to 

visit private offices of attending 

surgeons. Wound status 

determined by calling physician. 

No previously unidentified SSIs 

detected in clinic for the first 

time
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immunosuppressive 

drugs (including 

cancer chemotherapy) 

during the 4 weeks 

prior to surgery, a 

recent history of 

fever, infection or 

both, serious 

malnutrition (serum 

albumin <3.3g/dL, 

white blood cell count 

<2500 cells/mL, or the 

loss of more than 20% 

of body weight), or 

bowel obstruction.

Transfusion: Leukocyte 

depleted blood at 

surgeon’s discretion

O2- supplemental, nasal 

prongs at 6L/min first 

3hours postop, gradually 

eliminated to maintainO2 

sat >95%

Pain- opioids postop 

(patient controlled)

P=0.01

Vasoconstriction

Intervention: 6% of patients

Control: 74% of patients

P<0.001

Core Temperature at end of 

surgery

Intervention:36.6±0.5°C

Control: 34.7±0.6°C

P=<0.001 and remained 

significantly different for >5 

hours postoperatively

Postoperative 

Vasoconstriction 

Intervention: 22% (short-lived)

Control: 78% (continued 

throughout 6h recovery) 

P<0.001 

Shivering:

Intervention: “a few”

Control: 59% of patients

Thermal comfort score- VAS 1h 

postop: 

Intervention: 73±14mm

Control: 35±17mm

Remained statistically significant 

for 3h

Other: 

Pain score and amount of opioid 

administered “virtually identical” 

in the two groups at every postop 

measurement; hemodynamic 

values also similar.

Collagen deposition μg/cm

Intervention: 328±135

Control: 254±114

P=0.04

Days to first solid food:

Intervention: 5.6±2.5

Control: 6.5±2.0 
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P=0.006

Remained statistically significant 

even when analysis was limited 

to uninfected patients: 

Intervention: 5.2±1.6

Control: 6.1±1.6

P<0.001

Days to suture removal

Intervention: 9.8±2.9

Control: 10.9±1.9 

P=0.002

Remained statistically significant 

even when analysis was limited 

to uninfected patients: 

Intervention: 9.6±2.6

Control: 10.6±1.6

P=0.003

Days to suture removal in 

smokers (n=62) vs. non-smokers 

(n=138)

Smoker: 10.9±3.5 

Non-smoker10.1±2.0

P=0.04

Length of stay, days:

Intervention:12.1±4.4 

Control: 14.7±6.5

P=0.001

Remained statistically significant 

even when analysis was limited 

to uninfected patients:

Intervention: 11.8±4.1

Control:13.5±4.5

P=0.01

Analysis: smokers(n=62) vs. 

nonsmokers (n=138)

Smokers: 14.9±6.7 days

Non-smokers: 12.9±5.0 

P=0.02

Mortality:30 days

Intervention: 2/104(1.9%)
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Q5. What are the most effective strategies for achieving and maintaining perioperative normothermia? Our search did not 

identify RCTs or SRs that evaluated the most effective strategies for achieving and maintaining perioperative normothermia and 

their impact on the risk of SSI.

Control: 2/96 (2.1%)

Adverse events:

ICU Admission- (wound 

dehiscence, colon perforation, 

peritonitis) 

Intervention: 4/104 (3.9%)

Control: 7/96(7.3%)

P=0.47 
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RISK OF BIAS ASSESSMENTS OF STUDIES 4-5

Randomized Controlled Trials

Author

Year (RefID)

KQ Described 

as 

randomized

Randomization 

appropriately 

performed

Described 

as doubleblind

Outcome 

assessor 

blinded

Study 

participant 

blinded

Investigator 

blinded

Attrition 

described

Attrition smaller 

than 10-15% of 

assigned patients

Attrition 

appropriately 

analyzed

Funding source(s) 

disclosed and no 

obvious conflict of 

interest

Overall 

Risk of 

Bias

Question 4: Normothermia

Kurz

1996 58 4         Low

Melling

2001 57 4        Low

Wong

2007 59 4        Low
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Q6-7OXYGENATION 

GRADE TABLE Q6-7

Comparison Outcome

Quantity 

and Type of 

Evidence

Findings Starting 

GRADE

Decrease GRADE Increase 

GRADE

GRADE of 

Evidence for 

Outcome

Overall 

GRADE of 

Evidence 

Base

Study Quality

Consistency

Directness

Precision

Publication Bias

Large Magnitude

Dose-response

Confounders

Q6. In patients with normal pulmonary function, how safe and effective is the perioperative use of increased fraction of inspired oxygen (FiO2) in reducing the risk of SSI?

GENERAL ANESTHESIA (Intraoperative mechanical ventilation and postoperative non-rebreathing facemask or nasal cannula for 2-6 hours) 

80% oxygen vs. 

30% oxygen 

(Both groups 

without nitrous 

oxide) 

SSI, all* 5 RCT 60, 61, 

62, 63, 64

 3 high quality RCT60,61, 62 totaling 1,010 

colorectal (n=800) and open appendectomy 

(n=210) patients, each reported a 40% 

reduction in SSI with 80% oxygen. Each study 

optimized perioperative tissue oxygen delivery 

by standardizing patient core temperature 

regulation strategies targeted at maintenance 

of normothermia and fluid replacement to avoid 

hypo or hypervolemia

 1 high quality RCT 63in 1,400 patients 

undergoing a variety of general and gynecologic 

surgical procedures found no difference 

between groups. However, this study did not 

optimize tissue oxygen delivery as it failed to 

maintain perioperative normothermia and 

instituted aggressive perioperative fluid 

restriction. 

High 0 -1 0 0 0 0 0 0 Moderate

Moderate

Organ 

space 

infection

2 RCT 63,64

 Organ space infections reported in 5% of 1395 

patients, and comprised 28% of all SSI

 No difference between groups: 36/685 (5%) vs. 

39/701 (6%)

High 0 0 0 -1 0 0 0 0 Moderate
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Comparison Outcome

Quantity 

and Type of 

Evidence

Findings Starting 

GRADE

Decrease GRADE Increase 

GRADE

GRADE of 

Evidence for 

Outcome

Overall 

GRADE of 

Evidence 

Base

Study Quality

Consistency

Directness

Precision

Publication Bias

Large Magnitude

Dose-response

Confounders

Deep 

infection 2 RCT 63, 64

 Deep infections reported in 3% of 1395 

patients, and comprised 15% - 18% of all SSI; no 

difference between groups (OR: 0.80; 95% CI: 

0.42 – 1.51; p=0.52)

High 0 0 0 -1 0 0 0 0 Moderate

Superficial 

infection 2 RCT 63, 64

 Superficial infections reported in 11% of 1395 

patients, and comprised 54% - 57% of all SSI; no 

difference between groups (OR: 1.15; 95% CI: 

0.71 – 1.85; p=0.63)

High 0 0 0 -1 0 0 0 0 Moderate

ASEPSIS 

scores

4 RCT 60, 

61,62, 63

 2 RCTs 61, 62 found that 80% oxygen was 

associated with lower ASEPSIS scores

 2 RCTs 60, 63suggested that 80% oxygen was 

associated with fewer patients scoring >20 on 

ASEPSIS scale, but this finding was not 

significant

High 0 0 0 0 0 0 0 0 High

Mortality, 

14-30 days

4 RCT60, 62, 

63, 64

 1% mortality reported in elective colorectal 

surgery patients at 14days60, 62

 5% mortality reported in mixed emergency and 

elective laparotomy patients at 30days 63

 No difference between groups

 Mortality unrelated to use of increased fraction 

of inspired oxygen

High 0 0 0 0 0 0 0 0 High

Respiratory 

failure 

(14 days)

2 RCT 63, 64

 Respiratory failure, defined as the need for 

controlled ventilation or arterial oxygen 

saturation below 90% despite supplemental

oxygen was reported in 5% of patients 

 No difference between groups

High 0 0 0 -1 0 0 0 0 Moderate

Atelectasis 

(14 days) 2 RCT 63,64

 Atelectasis diagnosis based on a radiologist’s 

evaluation and description on chest radiograph 

or computed tomography 

 Reported in 8% of patients

High 0 0 0 -1 0 0 0 0 Moderate
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Comparison Outcome

Quantity 

and Type of 

Evidence

Findings Starting 

GRADE

Decrease GRADE Increase 

GRADE

GRADE of 

Evidence for 

Outcome

Overall 

GRADE of 

Evidence 

Base

Study Quality

Consistency

Directness

Precision

Publication Bias

Large Magnitude

Dose-response

Confounders

 No difference between groups

Tissue 

oxygen 

tension

1 RCT 62

 Subcutaneous tissue oxygen tension was higher 

in patients receiving 80% oxygen. This was 

noted both intraoperatively (109 mmHg vs. 

59mmHg; p<0.001) and postoperatively (73 mm 

Hg vs. 54 mm Hg; p=0.02)

High 0 0 0 -1 0 0 0 0 Moderate

Length of 

stay

4 RCT 60, 61, 

62, 63

 3 RCTs 63, 62, 60 found no statistical difference 

between groups

 The 2 colorectal surgery studies 62, 60 suggested 

that 80% oxygen was associated with one day 

longer duration of hospital stay but the findings 

were not significant: 12 vs.11 days; P=0.26 62

and p=0.09 60, respectively

 The 1 large, mixed surgical population RCT 63

suggested 80% was associated with one day 

shorter duration of hospital stay but the 

findings were not significant: 6 days (range, 1-34 

days) vs. 7 days (range, 2-36 days); OR -0.69 

(95% CI,-2.3-0.93); p=0.09 

 Only the 1 open appendectomy RCT 61 reported 

a significantly longer hospital stay in the 30% 

oxygen group (p=0.01).

High 0 -1 0 0 0 0 0 0 Moderate

80% oxygen vs. 

35% oxygen 

(both groups 

with nitrous 

oxide 30 minutes 

after incision)

SSI, all* 1 RCT 65

 One interim analysis 1 RCT (n=160) reported 29 

(18%) SSIs 

 80% oxygen was associated with an increased 

risk of SSI: OR: 2.63; 95% CI: 1.1 – 6.2; p=0.02; 

RR: 2.22 (95% CI, 1.1-4.6)

High 0 0 0 -1 0 0 0 0 Moderate

Moderate

Deep 

structures 

infection

1 RCT 65

 Deep structures infection reported in 4/160

(3%) of patients an no difference between 

group: 3/80 (4%) vs. 1/80 (1%); OR 3.08 (95%CI, 

High 0 0 0 -1 0 0 0 0 Moderate
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Comparison Outcome

Quantity 

and Type of 

Evidence

Findings Starting 

GRADE

Decrease GRADE Increase 

GRADE

GRADE of 

Evidence for 

Outcome

Overall 

GRADE of 

Evidence 

Base

Study Quality

Consistency

Directness

Precision

Publication Bias

Large Magnitude

Dose-response

Confounders

0.31-30.24); p=0.62

 Comprised 11% - 15% of all SSI

Wound 

infection 1 RCT 65

 Wound infection reported in 18/160 (11%) 

patients, comprising 56% - 65% of all SSI

 No difference between groups: 13/80 (16.25%) 

vs. 5/80 (6.25%): OR 2.91; 95% CI: 0.99 - 8.59; 

p=0.08

High 0 0 0 -1 0 0 0 0 Moderate

Both Deep 

structures 

and wound 

infection

1 RCT 65

 Both deep structures and wound infection 

reported in 7/140 (4%) patients, comprising 

20%-33% of all SSIs. 

 No difference between groups: 3/80 (3.75%) vs. 

4/80 (5%) OR: 0.74 (95% CI, 0.16 - 3.42); p=1

High 0 0 0 -1 0 0 0 0 Moderate

Mortality 1 RCT 65

 1 death reported, in the control group High 0 0 0 -1 0 0 0 0 Moderate

Length of 

stay

1 RCT 65

 This study suggested that 80% oxygen was 

associated with a longer mean length of stay 

(8.3 days vs. 6.4 days), but the finding was not 

significant (p=0.07)

High 0 0 0 -1 0 0 0 0 Moderate 

NEURAXIAL ANESTHESIA (Intraoperative and postoperative non-rebreathing facemask)

80% oxygen vs. 

30% oxygen 

SSI* 1 RCT 66

 1 small (n=143) interim analysis study in 

cesarean section patients found 80% oxygen 

delivered through a non-rebreathing facemask 

did not decrease the risk of SSI: no statistical 

difference between groups: 25% (95% CI, 15-

35%) vs. 14% (95% CI, 6-22%); p=0.13.

High 0 0 0 -1 0 0 0 0 Moderate

Moderate

Length of 

stay

1 RCT 66  No difference between groups: median days 

(range): 3 (2-5) vs. 3 (2-6); p=.92 High 0 0 0 -1 0 0 0 0 Moderate

POSTOPERATIVE ONLY (Facemask and/or nasal cannula)
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and should not be construed to represent any agency determination or policy. 150

Comparison Outcome

Quantity 

and Type of 

Evidence

Findings Starting 

GRADE

Decrease GRADE Increase 

GRADE

GRADE of 

Evidence for 

Outcome

Overall 

GRADE of 

Evidence 

Base

Study Quality

Consistency

Directness

Precision

Publication Bias

Large Magnitude

Dose-response

Confounders

28-30 % oxygen 

vs. room air

SSI, all* 2 RCT 67, 68

 In1 RCT (517068) of 274 lower limb vascular 

surgeries, multivariate analysis suggested no 

difference between groups: 18% vs. 28%; OR:

0.56 (95% CI: 0.30 – 1.04); p = 0.07). Isolated 

groin incision SSIs were significantly lower in the 

supplemental (30%) oxygen group: 5.8% vs. 

23.5%; OR:0.20 (95% CI, 0.04-0.95) ;p=0.04

 One lesser quality study (318167) of 24 cervical 

spine surgeries reported no SSIs

High 0 0 0 0 0 0 0 0 High

High

Organ 

Space 1 RCT 68  No infections in the intervention group vs. 2 

infections (3%) in the control group High 0 0 0 -1 0 0 0 0 Moderate

Deep 

infection 1 RCT 68

 No difference : 5.1% in each group High 0 0 0 -1 0 0 0 0 Moderate

Superficial 

infection 1 RCT 68  No difference: 18/137 (13%) vs. 29/137(21%); 

OR 0.56; (95%CI, 0.30-1.07); p=0.11. High 0 0 0 -1 0 0 0 0 Moderate

ASEPSIS 

scores

1 RCT 67  All within satisfactory healing (Score 0-10) 

 No difference observed between groups High -1 0 0 -1 0 0 0 0 Low

Mortality, 

30 days 1 RCT 68

 Mortality was rare (4 deaths among 274 

patients) and did not differ by group: 3/137 

(2.2%) vs. 1/137 (0.7%); OR 3.0 (95% CI 0.31-

28.99); p=0.62.

High 0 0 0 -1 0 0 0 0 Moderate

Adverse 

events

2 RCT 67, 68

 Adverse events were rare and did not differ 

between groups

 Reported adverse events include: wound 

complications, graft thrombosis, cardiac 

complications, pneumonia, stroke, renal 

insufficiency, major amputation

High 0 0 0 -1 0 0 0 0 Moderate
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and should not be construed to represent any agency determination or policy. 151

Comparison Outcome

Quantity 

and Type of 

Evidence

Findings Starting 

GRADE

Decrease GRADE Increase 

GRADE

GRADE of 

Evidence for 

Outcome

Overall 

GRADE of 

Evidence 

Base

Study Quality

Consistency

Directness

Precision

Publication Bias

Large Magnitude

Dose-response

Confounders

Tissue 

oxygen 

tension

1 RCT 67

 Subcutaneous tissue oxygen tension was higher 

in patients receiving supplemental oxygen (63 

mm Hg vs. 48 mm Hg; p=0.001)

High -1 0 0 -1 0 0 0 0 Low

Length of 

stay

1 RCT 68  No difference observed between groups: 6.5d 

vs. 5.4d; p-=0.13. High 0 0 0 -1 0 0 0 0 Moderate

*Critical outcome; OR: Odds Ratio; RR: Risk Ratio; CI: Confidence Interval
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and should not be construed to represent any agency determination or policy. 152

EVIDENCE TABLE Q6-7

Q6. In patients with normal pulmonary function, how safe and effective is the perioperative use of increased fraction of inspired 

oxygen (FiO2) in reducing the risk of SSI?

Author 

Year 

(Data 

Extractor)

Risk of 

Bias 

Score

Study 

Objective Population and Setting Intervention Results Comments

Staehr 

201164

(ES)

RCT

1, 2, 3, 4, 

5, 6, 7, 8, 

9, 10

To evaluate 

the effect of a 

high 

inspiratory 

oxygen 

fraction (80%) 

on SSI and 

pulmonary 

complications 

in obese 

patients 

undergoing 

laparotomy.

Number of patients: N: 213

Patient Characteristics: 

All demographic and 

perioperative characteristics 

were similar between groups.

Population Characteristics

Age: ≥18 years

Gender: m/f: 86/127

Morbidly Obese: 73/213 (32%)

All characteristics below are 

given are for the intervention 

group N=102:

Median [5-95% range] or N (%)

Age: 63y [37-81]

Gender: m/f:43/59

Obesity:

Median BMI: 34 kg/m2[30-44] 

BMI≥35kg/m2:39 (38%)

Comorbidity:

 Current smoker: 31 (30%)

 Diabetes mellitus: 16 (16%)

 Pulmonary Disease: 16 (16%)

 Hypertension: 48 (47%)

 Other cardiovascular disease: 

15 (15%)

Duration of surgery: 145 [45-

309] min

Epidural analgesia: 

thoracic/lumbar/none:

 66/4/32

Type of anesthesia:

Intervention: n=102

Intraop: Patients were preoxygenated with 100% FiO2 until 

tracheal intubation.

Patients were given 80% FIO2 from 

intubation until the end of 

surgery when 100% FIO2 was 

given immediately before 

extubation. FIO2 was increased 

to ensure arterial oxygen above 

94%. 

Postop: The first 2h after surgery 

patients received 80% FIO2 from 

the Nonrebreathing facemask 

and an oxygen flow of 14 l/min 

and an air flow of 2 l/min. 2 hrs. 

after surgery, supplemental O2

was administrated according to 

clinical practice

Timing of Intervention: Intra and 

Postoperatively

Duration of Treatment: Intubation 

to 2 hours after surgery. 

Device: Nonrebreathing facemask 

with a reservoir

Control: n=111

Intraop: Patients were preoxygenated with 100% FiO2 until 

tracheal intubation.

Patients were given 30% FIO2 from 

intubation until the end of 

SSI (Follow up 14 days postop)

Overall: 29%

Intervention: 32/102 = 31%

Control: 29/111= 26%

Univariate OR:

1.29 (95% CI, 0.71-2.34)

P= 0.40

Adjusted OR:

1.22 (95%CI, 0.63-2.39)

P=0.57

Superficial infection

Intervention: 16/32 (50%)

Control: 21/29 (73%) 

Deep Infection

Intervention: 8/32 (25%)

Control: 5/29 (29%)

Organ Space Infection

Intervention: 8/32 (25%)

Control: 3/29 (10%)

Incidence of SSI

Obese Patients = 27%

Morbidly Obese Patients 

n=73(32%)

Sub-analysis of SSI between 

Intervention groups 

distributed by weight class. 

(interpreted from graph (%SSI 

[upper 95% CI])

Underweight (BMI<18.5kg/m2)

 Intervention: 10% [25%]

 Control:19% [37%]

Normal Weight (BMI 18.5-24.9 

Definitions:

SSI: CDC definitions (Within 14 

days)

Pneumonia: CDC (Within 14 days)

Adverse Event: ND

Serious adverse event: Serious if 

fatal, life threatening, caused 

permanent disability, or 

required prolonged 

hospitalization

Obese: BMI 30-34.9kg/m2

Morbidly Obese: BMI ≥ 35kg/m2

Overweight: BMI= 25.0-29.9kg/m2

Normal Weight: BMI= 18.5-

24.9kg/m2

Underweight: BMI<18.5 kg/m2

Perioperative Care:

Anesthesia-standardized, nonnitrous oxide

Other notes: 

This was a planned subgroup 

analysis of the PROXI trial; 

Meyhoff 2009(9052).

Adjusted OR adjusted for study 

center, diabetes mellitus, acute 

surgery, COPD, current smoker, 

upper abdominal incision, 

duration of surgery, and age 

(≥40 years or <40 years) where 

possible

Preoperative SSI Risk Stratification:

SENIC 1/2/3/4
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and should not be construed to represent any agency determination or policy. 153

Author 

Year 

(Data 

Extractor)

Risk of 

Bias 

Score

Study 

Objective Population and Setting Intervention Results Comments

 Volatile: 25 (25%)

 Total IV: 77(75%)

Procedure: Laparotomy 

Colorectal: 

Intervention: 40/102 (39%)

Control: 49/111 (44%)

Primary Anastomic:

Intervention: 31/102 (30%)

Control: 41/111 (37%)

Other surgeries:

Intervention: 62/102 (61%)

Control: 41/111 (56%)

Acute procedures: 

Intervention: 19/102 (19%)

Control: 20/111 (18%)

Operation Classification

Clean: 36 (35%)

Clean Contaminated: 21 (21%)

Contaminated: 43 (42%)

Dirty-infected 2 (2%)

Indications: 

Cancer Diagnosis

Intervention: 56/102 (57%)

Control: 57/111 (51%)

Other:

Intervention: 46/102 (45%)

Control: 54/111 (49%)

Setting: Multi-Center

Location: Denmark

Dates of Study: October 8, 2006 

- October 6, 2008

Inclusion Criteria: 18 years or 

older, BMI≥ 30kg/m2, 

scheduled for acute or 

surgery when 100% FIO2 was 

given immediately before 

extubation. FIO2 was increased 

to ensure arterial oxygen above 

94%. 

Postop: The first 2h after surgery 

patients received a mixture of O2

(2 l/min) and air (14 l/min) 

through above face mask. 2 hrs. 

after surgery, supplemental O2

was administrated according to 

clinical practice

Monitoring Intervention: Pulse 

oximetry

Standard Preventative Measures: 

Analgesia: epidural

Normothermia: ensured adequate 

temperature

Glycemic: ensured adequate glucose 

control

AMP: appropriate and timely 

prophylactic antimicrobials

Received Adequate AMP 

Intervention n=90(88%)

Control n=91 (82%)

Received Timely AMP 

Intervention n=64 (63% ) 

Control n=75 (71%)

Bowel Prep: absence of 

preoperative oral bowel prep

Fluids: Given only once to replace 

measured or calculated deficits 

aiming at body weight increase 

of less than 1kg. Blood loss was 

kg/m2)

 Intervention: 17% [20%]

 Control:18% [21%]

Over Weight (BMI 25.0-

29.9kg/m2)

 Intervention: 19% [24%]

 Control:22% [28%]

Obese (BMI 30.0-34.9 kg/m2)

 Intervention: 30% [42%]

 Control:26% [36%]

Morbidly Obese (BMI ≥35.0 

kg/m2)

 Intervention: 33% [49%]

 Control:30% [48%]

Per-protocol analysis (N= 167) of 

primary and secondary 

outcomes showed results 

similar to those in the ITT 

analysis (N=213):

SSI-per protocol analysis

Intervention: 31/91 (34%)

Control: 24/76 (32%)

P=0.73.

Other infections:

Pneumonia (Follow up 14 days)

Intervention:5.9%

Control: 4.5%

Obese:6%

Morbidly obese: (3%)

Reoperation: n=43(20%); 

Intervention: 22/102 (22%)

Control: 21/111 (19%)

Reoperation for SSI n=24 (11%)

Intervention: 24/32/42/4

Control: 25/35/47/4

NNIS, 0/1/2/3

Intervention: 20/50/26/6

Control:28/47/29/7

Pulmonary complications 

monitored by clinical exam 

(attending physician), including 

chest radiographs or computed 

tomography evaluated by 

radiologist blinded to allocation

Follow-Up: visit conducted 

between postoperative day 13 

and 30. Most outcomes 

measured at 14 days post op 

except for mortality at 30days.
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and should not be construed to represent any agency determination or policy. 154

Author 

Year 

(Data 

Extractor)

Risk of 

Bias 

Score

Study 

Objective Population and Setting Intervention Results Comments

elective laparotomy

Exclusion Criteria: Inability to 

give informed consent, 

chemotherapy for 

malignancy within 3 months, 

surgery performed under 

general anesthesia within 30 

days, preoperative arterial 

oxygen saturation less than 

90% w/o supplemental 

oxygen assessed by pulse 

oximetry.

replaced 1:1 with colloids and 

blood transfusion was initiated if 

blood loss exceeded 20ml/kg

Debridement n=5 (2%)

Length of stay:

Intervention: 6 (1-35) days

Control: 5 (2-45) days

30 Day Mortality: Total: 2%

Intervention: 1/102 (1%)

Control: 3/111 (2.7%)

Adverse Events:

Any adverse event

 Intervention: 52/102 (51%)

 Control: 58/111 (52%)

 Wound related:

 Intervention: 18/102 (18%)

 Control: 20/111 (18%)

Any serious event: 

 Intervention: 22/102 (22%)

 Control: 22/111 (20%)

 Sepsis

 Intervention: 4/102 (3.9%)

 Control: 3/111 (2.7%)

Pulmonary Complications: 

Not significantly different

Atelectasis (Follow up 14 days 

postop)

 Intervention: 9/102(8.8%)

 Control: 7/111 (6.3%)

 Obese:9%

 Morbidly Obese:5%

Respiratory Failure(Follow up 14 

days postop)

 Intervention: 8/102 (7.8%)

 Control: 5/111 (4.5%)

 Obese: 6%

 Morbidly obese:5%

Anastomotic leak

 Intervention: 2/31 (6%)
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and should not be construed to represent any agency determination or policy. 155

Author 

Year 

(Data 

Extractor)

Risk of 

Bias 

Score

Study 

Objective Population and Setting Intervention Results Comments

 Control: 2/41 (5%)

Rupture of abdominal fascia

15/213 (7%) of patients had 

ruptured abdominal fascia 

compared with 9/658 (1%) of 

normal weight patients in PROXY 

trial 

 Intervention: 9/102 (9%)

 Control: 6/111 (5%)

Admission to ICU (within 14 days 

if not part of normal routine care)

 Intervention: 11/102 (10%)

 Control: 9/111 (8%)

Turtiainen 

2011 68

(ES)

RCT

1, 2, 4, 6, 

7, 8, 9

To test the 

hypothesis 

that 

supplemental 

postoperative 

oxygen 

decreases the 

incidence of 

Surgical 

Wound 

Infection (SWI) 

after lower 

limb 

revascularizati

on

Number of patients: N=274

Patient Characteristics: 

Characteristics were analyzed 

and not found to be 

statistically different 

between groups.

Characteristics reported below 

are for the intervention

Age: ≥ 18 (Mean: 73.5 [SD 11])

Gender (m/f): 78/59

Obesity:

BMI, mean: 26 kg/m2(SD 4)

Co-Morbidities:

 Coronary artery disease: 65 

(47%)

 Diabetes: 50 (36%)

 Hypertension: 89 (65%)

 Rheumatoid arthritis: 7 (5%)

 COPD: 13 (9%)

 Asthma: 11 (8%)

 Dialysis: 5 (4%)

Intervention: n=137

Postop: 30% FIO2 was delivered via 

face mask in the recovery room 

and on the 1st postoperative day. 

On the 2nd postoperative day 

supplemental oxygen was 

delivered via nasal cannula at a 

constant flow rate of 5l/min.

Timing of Intervention:

Postoperatively

Duration of Treatment:

From the end of surgery until 10PM 

on 2nd postoperative day (at least 

48hrs)Device: 

A face mask for the 1st day to deliver 

30% O2.

On 2nd postop day, FIO2 was 

delivered via nasal cannula. 

Monitoring Intervention:

Oxygen level of a toe on operated 

limb was measured w/ pulse 

SSI

Total SSI: 63/ 274 (23%) 

 Superficial: 47/63 (74%)

 Deep: 14/63 (22%)

 Organ/Space: 2/63 (3%)

Intervention vs. Control SSI:

Intervention: 25/137 patients 

(18.2%)

Control: 38/137 patients (27.7%)

P=0.06

Multivariate 

OR 0.56 (95% CI, 0.30-1.04; 

P=0.07)

Superficial SSI:

Intervention: 18/137 (13%)

Control: 29/137 (21%)

Deep SSI:

Intervention: 7/137 (5.1%)

Control: 7/137 (5.1%)

Organ/Space SSI (vascular graft)

Definitions:

SSI – CDC definition

Surgical wound infection (SWI) was 

considered infection if there 

were bacteria isolated from the 

wound or if there were areas of 

localized redness, heat, swelling

and pain around the wound 

appearing w/in 30 days after 

operative procedure.

Surgical wounds were evaluated by 

vascular surgeon blinded to 

study arm.

Pneumonia: clinical diagnosis and 

correlative changes in chest xray film

Perioperative Care:

Shaving around intended surgical 

wound site done in operating 

room just before surgery.
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and should not be construed to represent any agency determination or policy. 156

Author 

Year 

(Data 

Extractor)

Risk of 

Bias 

Score

Study 

Objective Population and Setting Intervention Results Comments

 Current smoking: 37 (27%)

Blood loss (ml [SD]): 341 (337)

Procedure: N=274

Non-emergency, lower limb 

arterial surgery 

(revascularization)

- 173 bypass procedures

 44/173 (25%) prosthetic grafts

Femoral endarterectomy n=84

Femoral bypass n=12

Femoropopliteal bypass n=92

Crural bypass n=46

Pedal bypass n=19

Embolectomy n=3

Other n=18

Operative area

Inguinal:n-105

Infrainguinal: n=169

Indications:

 Claudication: 94/ 274 (34%)

 Rest pain: 68/ 274 (24.8%)

 Ischemic ulcer: 100/274 

(36.5%)

 Other: 7//274 (4.4%)

Setting: 5 Secondary referral 

hospitals & 1 tertiary referral 

hospital

Location: Finland

Dates of Study: May 2009-

February 2010

(Varied between 3 and 6 months 

between 6 hospitals.)

Inclusion Criteria:

Adult patients who underwent 

oximeter every 4 hours for 1st 2 

days.

Control: n=137

Postop: Breathed room air

Standard Preventative Measures:

AMP: Antimicrobial prophylaxis was 

standardized to 3g cefuroxime 

via IV w/in 1h before incision. If 

operation > 4h or blood 

loss>1,500ml then another 1.5g 

Cefuroxime was administered.

AMP per protocol: n=244 (89%)

No AMP n=4

Received 1.5g cefuroxime n=10

Treated for infected ulcer n=11

Treated for UTI n=3

Treated for sepsis n=2

Intervention:0/137 (0%

Control: 2/137 (3%)

Factors associated w/ SSI

(multivariate analysis)

Prosthetic material use

0.02 (95%CI 0.08-0.50) p=0.001

Asthma

4.83 (95%CI 1.72-13.53) p=0.003

Infrainguinal incision

2.24 (95%CI 1.07-4.67) p=0.03

Coronary Artery Disease

1.94 (95%CI 1.04-3.62) p=0.04

Supplemental oxygen

0.56 (95%CI 0.30-1.04) p=0.07

Sub-group analysis

103 patients w/ inguinal (isolated 

groin) incision only

SSI

Total SSI 15/103 (15%)

Intervention: 3/52 (6%)

Control: 12/51 (24%)

P=0.01

No differences in secondary 

outcomes between groups in 

the sub-group analysis

BMI>25kg/m2 was independent 

risk factor for SWI

OR 1.22, 95%CI 1.03-1.45;P=0.02

Supplemental oxygen was 

associated with reduced risk

OR, 0.20, 95%CI, 0.04-0.95;P=0.04

Other infections: 

Pneumonia: p=0.18

Intervention: 1/137 (0.7%)

Control: 4/137 (2.9%)

Other notes:

Primary study design was to deliver 

supplemental oxygen via face 

mask for the first two 

postoperative days but patients 

found the face masks to be 

uncomfortable so the initial 

plan was changed 2 weeks after 

data collection had started.

Whether patient received AMP per 

protocol or not, did not affect 

incidence of SWI.

Follow-Up: For 30 days or until the 

SWI healed
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and should not be construed to represent any agency determination or policy. 157

Author 

Year 

(Data 

Extractor)

Risk of 

Bias 

Score

Study 

Objective Population and Setting Intervention Results Comments

non-emergency lower limb 

arterial surgery

Exclusion Criteria

Refusal to participate, 

hypercapnic chronic obstructive 

pulmonary disease (COPD), or 

oxygen saturation less than 90% 

measured by a finger pulse 

oximeter when breathing room 

air.

Topic-specific outcomes:

Mean toe tip oxygen saturation 

after surgery. Was not 

significantly different between 

2 groups except at:

24hrs after surgery

Intervention: 94.4% 

Control: 91.9%

P=0.034

28hrs after surgery

Intervention: 95.0% 

Control: 92.4%

P=0.025

Reoperation: 

58/63 (92%) SSI patients were 

cured with treatment2/63 (3%) 

SSI patients required limb 

amputation due to SSI (one 

study one control group)

Length of Stay: Postoperative stay

Intervention: 6.5d (SD9.4)

Control: 5.4d (SD4.3)

P=0.13

Mortality: at 30 days

Intervention: 3/137 (2.2%)

Control: 1/137 (0.7%)

Cause of death: 

1 aspiration pneumonia 

3 myocardial infarction (MI) 

including one intervention patient 

died from an MI on POD#30 and 

SWI had not yet healed, 

3 had no SWI at the time of death

Of note: 1 control group patient 
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and should not be construed to represent any agency determination or policy. 158

Author 

Year 

(Data 

Extractor)

Risk of 

Bias 

Score

Study 

Objective Population and Setting Intervention Results Comments

died of renal failure on POD#64 

and had a SWI not cured at the 

time of death

Adverse Events

Graft Thrombosis: p=0.39

Intervention: 5/137 (3.6%)

Control: 8/137 (5.8%)

Cardiac complication: p=0.81

Intervention: 6/137 (4.4%)

Control: 5/137 (3.6%)

Stroke: p=0.08

Intervention: 3/137 (2.2%)

Control: 0/137 (0%)

Renal insufficiency: p=0.31

Intervention: 3/137 (2.2%)

Control: 1/137 (0.7%)

Bickel 

2011 61

(ES)

RCT

1, 2, 3, 4, 

5, 6, 7, 8 

10

To assess the 

influence of 

hyperoxygenation 

on surgical site 

infection by 

using the most 

homogeneous 

study 

population: 

single 

diagnosis 

(acute 

appendicitis) 

using 1 

standard 

surgical 

approach 

Number of patients : N=210

Patient Characteristics: No 

statistically significant 

difference in characteristics 

between the 2 groups. 

(Including smoking history, 

obesity, shaving, and timing 

of antimicrobial 

administration). All patients 

categorized as having ASA 

score of 1 or 2.

Age, years: 28.0 (SD 11.5; range 

15-71)

Gender (m/f): 152/57

Obesity: NR

Co-morbidities (out of n=210)

 Ischemic heart disease: 3.1%

 Hypertension: 7.4%

Intervention: n= 107

Intraop: FIO2 80% combined with 

20% air. 

Postop: In recovery room, flow rate 

was 10L/min (high-flow) for 2 

hours via non-rebreathing mask.

Timing of Intervention:

Intra- & post-operatively

Duration of Treatment:

From Induction of anesthesia to 2 

hours post-operatively

Device: Nasal cannula for control 

and nonrebreathing mask with a 

reservoir for the intervention

Monitoring Intervention:

Pulse oximetry during anesthesia & 

recovery period. Arterial blood 

was obtained after anesthesia 

SSI Cases

Total SSIs: 20/210 (9.5%)

Intervention: 6/107 (5.6%)

Control: 14/103 (13.6%) 

P=0.04

SSI by patient subgroup

Normal appendix (n=9)

Intervention: 0/4

Control: 0/4

P >.99

Acute appendicitis (n= 35)

Intervention: 2/18 (11%)

Control: 0/17 

P=0.20

Phlegmonous appendicitis 

Definitions:

SSI: Evaluated clinically according 

to obvious signs and symptoms 

such as local induration & 

erythema, purulent discharge &

need to explore the wound. 

Supportive results included 

increased white blood cell 

count, fever, and radiological 

evidence of infectious 

collections, positive culture 

findings and resolution of mild 

infectious findings following 

antimicrobial treatment.

ASEPSIS score taken

Perioperative Care:

Anesthesia was introduced with 
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and should not be construed to represent any agency determination or policy. 159

Author 

Year 

(Data 

Extractor)

Risk of 

Bias 

Score

Study 

Objective Population and Setting Intervention Results Comments

(open 

appendectomy 

through a 

McBurney 

incision in the 

right lower 

quadrant of 

the abdomen).

 Diabetes: 0.6%

 Pulmonary disease: 1.3%

Procedure: Open appendectomy 

through a McBurney incision 

in the right lower quadrant of 

the abdomen

Indications: acute appendicitis 

diagnosed by clinical criteria 

(right lower quadrant pain, 

local tenderness, etc.), blood 

test results & results of 

imaging modalities 

(ultrasonography or 

abdominal computed 

tomography) suggestive of 

acute appendicitis

Setting: Department of surgery 

in a Government Hospital

Location: Israel

Dates of Study: November 1, 

2006 – May 31, 2009

Inclusion Criteria:

Adults (>15 years) with acute 

appendicitis having open 

appendectomies

Exclusion Criteria

Chronic obstructive pulmonary 

disease, severe malnutrition 

(serum albumin conc. <3g/dL) or 

immunodeficiency disease

induction & during surgery and 2 

hours after recovery from 

anesthesia.

Surgical wounds evaluated daily. 

After discharge, evaluation was 

done at surgical outpatient clinic 

by senior surgeon w/in 2 weeks 

of surgery

Control: n=103

Intraop: FIO2 30% O2 combined with 

70%N. 

Postop: In recovery room, flow rate 

was 4L/min for 2 hours.

Standard Preventative Measures:

Antimicrobial prophylaxis-: 

Preoperative antimicrobials: 

aminoglycosides (gentamicin 

sulfate) and metronidazole. 

When intraoperative findings 

indicated gangrenous or 

perforated appendicitis, 

antimicrobial treatment lasted 5 

days. 

Fluids: Adequate hydration was 

strictly maintained during the 

operation and convalescence 

Ventilation: mechanically controlled 

at a frequency and tidal volume 

to maintain normocapnea.

Normothermia: Core temperature 

was strictly maintained during 

the operation and convalescence 

Wound closure: Following resection 

of inflamed appendix, the 

surgical wound in the lower right 

(n=123)

Intervention: 1/63 

Control: 6/60 

P=0.049

Gangrenous appendicitis (n=43)

Intervention: 3/22 (13.6%)

Control: 8/21 (38.1%) 

P=0.06

ASEPSIS Score

Satisfactory Healing

Intervention: 101 (94.4%)

Control: 89 (86.4%)

Disturbance of healing 

Intervention: 2 (1.8%)

Control: 5 (4.9%)

Minor wound infection:

Intervention: 2 (1.8%)

Control: 3 (2.9%)

Moderate wound infection:

Intervention: 2 (1.8%)

Control 5 (4.9%)

Severe wound infection:

Intervention: 0 (0%)

Control 1 (1.0%)

ASEPSIS Score: “A significant 

difference was recorded 

between the two study 

populations” (P=0.03)”

Wound problems

Intervention: 6/ 107 (5.6%)

Control: 14/ 103 (13.6%)

Other infections: NR

Topic-Specific outcomes: 

Partial pressure of oxygen (PO2) in 

fentanyl citrate, propfol, or 

thiopental sodium, and 

rocuronium bromide or 

atracurium besylate following 

pre-oxygenation via mask.

It was maintained with nitrous 

oxide and oxygen, isofluorane, 

1% rocronium bromide, or 

atracurium besylate, and 

fentanyl citrate.

Other Notes:

Preoperative SSI Risk Stratification:

SENIC & NNIS

They note that while the rate of SSI 

reached statistical significance 

(P=0.04), using the 2-tailed 

Fisher exact test will lead to a 

P=0.06

Follow up: 14 days for SSI, then 

length of hospital stay
Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminated by the Centers for Disease Control and Prevention 

and should not be construed to represent any agency determination or policy. 160

Author 

Year 

(Data 

Extractor)

Risk of 

Bias 

Score

Study 

Objective Population and Setting Intervention Results Comments

quadrant of the abdomen was 

meticulously irrigated and 

sutured with absorbable sutures. 

Skin was closed with metal clips 

(including cases of gangrenous 

appendicitis).

arterial blood: mean (SD);P-value

Before starting surgery:

Intervention: 263.30 (87)

Control: 179.95(78)

P=0.001

During surgery before wound 

closure

Intervention: 275.47 (95) 

Control: 149.37 (48)

P=0.001

In recovery room

Intervention 188.6 (73)

Control 142.3 (65)

P=-0.02

Reoperation:

Wound exploration 12/20 SSIs

Intervention: 4/6 (66.7%)

Control: 8/14 (57.1%)

P>0.99

Length of stay: mean (SD)

Total: 2.71 days (1.25)

Intervention: 2.51 days (0.88)

Control: 2.92 days (1.05)

P=0.1

Mortality: NR

Adverse Effects: NR

Meyhoff 

2009 63

(ES)

RCT

1, 2, 3, 4, 

5, 6, 7, 8, 

9, 10

To assess 

whether use of 

80% oxygen 

reduces the 

frequency of 

surgical site 

infection 

without 

Number of patients: N = 1395

Patient characteristics: Preoperative and perioperative 

characteristics compared and 

no statistically significant 

difference found between 

groups. (data below listed for 

intervention)

Intervention: n=690

Intraop: 100% FIO2 at induction of 

anesthesia until intubation. Then 

80% FIO2 from intubation until 

the end of surgery. 

Postop: The first two hours 

following intubation patients 

received 80% FIO2 via a 

SSI: Follow up 14 days

Intervention: 131/685 (19.1%)

Control: 141/701 (20.1%)

Univariate OR

0.94 (95%CI 0.72-1.22) p=0.64

Adjusted OR

0.91 (95%CI 0.69-1.2) p=0.51

Definitions:

SSI: CDC definitions

Pneumonia- CDC Criteria (NNIS)

Respiratory failure- the need for 

controlled ventilation or arterial 

oxygen saturation below 90% 

despite supplemental oxygen

BMI: <30 or ≥30 calculated as 
Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminated by the Centers for Disease Control and Prevention 

and should not be construed to represent any agency determination or policy. 161

Author 

Year 

(Data 

Extractor)

Risk of 

Bias 

Score

Study 

Objective Population and Setting Intervention Results Comments

increasing the 

frequency of 

pulmonary 

complications 

in patients 

undergoing 

abdominal 

surgery 

(laparotomy).

Age: (median(5-95%)) : 64y (27-

85)

Gender: 

Men (no (%)): 228/690 (41.7%)

Obesity:

BMI, median (5-95%): 25kg/m2

(18-35)

BMI≥30, no (%): 102/690 

(14.8%)

Comorbidity:

 Current smoker: 207/690 

(30.0%)

 Alcohol consumption >48g/d: 

29/690 (4.2%)

 Previous abdominal surgery: 

298/690 (43.2%)

 Diabetes mellitus 51/690 

(7.4%)

 COPD: 35/690 (5.1%)

 Other pulmonary disease: 

45/690 (6.5%)

 Hypertension: 209 (30.3%)

 Other cardiovascular disease: 

125/690 (18.1%)

 Current signs of infection: 

76/690 (11.0%)

 Immune deficiency: 27/690 

(3.9%)

 Other disease209/690 (30.3%)

Procedure: (N=1386)

Colorectal: 633/1386 (45.7%)

Gynecological: 268/1386 

(19.3%)

Small Bowel surgery: 158/1386 

(11.4%)

Appendectomy: 124/1386 

nonrebreathing mask with a 

reservoir w/ a flow of 14L O2 & 

2L air per minute

Timing of Intervention:

Intra & Postoperatively

Duration of Treatment: From 

induction of anesthetic to 2hrs 

postop

Device: High concentration oxygen 

mask

Monitoring Intervention: Pulse 

Oximetry

Control: n=705

Intraop: 100% FIO2 at induction of 

anesthesia until intubation. Then 

30%FIO2 from intubation until 

end of surgery. 

Postop: During the first two hours 

after surgery, patient received O2

via Nonrebreathing mask w/ a 

flow of 14L air & 2L O2 per 

minute.

In both groups FIO2 was increased if 

hypoxia was detected or 

suspected to ensure arterial 

oxygen saturation >94% and 

arterial oxygen tension >9kPa.

Standard Preventative Measures:

Analgesia - Epidural

Normothermia: control of 

temperature

Glycemic: Control of glucose level

Bowel Prep: absence of preInfection Location:

Superficial:

Intervention: 75/131 (57.3%)

Control: 76/141 (53.9%)

Deep

Intervention: 20/131 (15.3%)

Control: 26/141 (18.4%)

Organ/ Space (Intra-abdominal)

Intervention: 36/131 (27.5%)

Control: 39/141 (27.7%)

ASEPSIS Score>20:

Intervention: 32(4.7)

Control: 36 (5.1)

Per protocol analysis (N=1081)

SSI 

Intervention: 122/555 (22.0%)

Control: 116/526 (22.1%)

P=0.98

Other infections:

Pneumonia: (14 days)

Intervention: 41/685 (6.0%)

Control: 44/701 (6.3%)

Univariate OR

0.95 (95%CI 0.61-1.48) p=0.82

Adjusted OR

0.95 (95%CI 0.60-1.49) p=0.81

Topic Specific outcomes: NR

Reoperations: For all reasonsdoes not specify how many for 

SSI

Intervention: 104/685 (15.2%)

Control: 104/701 (14.8%)

Length of stay: Postoperative 

weight in kg divided by height in 

m

2

Risk of SSI assessed with NNIS and 

SENIC.

Perioperative Care:

Standardized inhalational or 

intravenous anesthesia without 

nitrous oxide depending on 

attending anesthetist. 

Other notes: 

Adjusted OR adjusted for study 

center, BMI (<30 or ≥30), 

diabetes mellitus, acute or 

elective surgery, COPD, current 

smoker, incision extending 

above umbilicus, duration of 

surgery, and age (≥40 years or 

<40 years)

Follow-Up: SSI monitoring for 14 

days, Then postop day 13-30 via 

telephone if necessary
Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminated by the Centers for Disease Control and Prevention 

and should not be construed to represent any agency determination or policy. 162

Author 

Year 

(Data 

Extractor)

Risk of 

Bias 

Score

Study 

Objective Population and Setting Intervention Results Comments

(8.9%)

Other: 203/1386 (14.6%)

Operation Classification:

Clean: 318/1386 (22.9%)

Clean-contaminated: 796/1386 

(57.4%)

Contaminated: 235/1386 

(17.0%)

Dirty-Infected: 37/1386 (2.7%)

Indications: (# of patients/1386)

Cancer: 714 (51.5%) 

Benign neoplasm: 108 (7.8%)

Appendicitis: 121 (8.7%)

Intestinal obstruction due to 

benign disease: 124 (8.9%)

Inflammatory bowel disease: 79 

(5.7%)

Diverticulitis: 57 (4.1%)

Other: 183 (13.2%)

Setting:14 Hospitals

Location: Denmark

Dates of Study: Oct 2006- Oct 

2008

Inclusion Criteria: Patients 

≥18yrs who underwent acute 

or elective laparotomy. 

(When laparotomy was 

indicated for gynecological 

disease, only patients with 

suspected malignancy [risk of 

ovarian malignancy 

index>200 or a specimen 

showing atypical or 

neoplastic cells] were 

included.)

operative bowel preparation.

AMP: first and second antimicrobial 

administered w/in 60 minutes of 

skin incision. Cefuroxime & 

metronidazole given 

intravenously was standard 

choice, but ampicillin or 

benzylpenicillin in combination 

with gentamicin and

metronidazole were also 

allowed.

 1305/1386 (94%) received AMP. 

 Of those that received AMP:

 1169/1305 (90%) Appropriate 

AMP

 880/1305 (67%) Timely AMP

Fluids: given only to replace 

measured or calculated deficits 

aiming at a post-op weight 

increase of less than 1kg

Transfusion: blood replaced 1:1 with 

colloids & transfusion initiated if 

blood loss exceeded 20 mL/kg.

hospitalization (Mean? 

(range)) 

Intervention: 6d (1-34)

Control: 7d (2-36)

OR -0.69 (-2.3-0.93) P=0.09

Mortality: at 30 days

Intervention: 30/685 (4.4%)

Control: 20/701 (2.9%)

Univariate OR

1.56 (95%CI 0.88-2.77) p=0.13

Adjusted OR

1.55 (95%CI 0.86-2.85) p=0.15

Adverse Effects: Wound-related, 

UTI, Postoperative nausea or 

vomiting, respiratory, 

circulatory, gastrointestinal 

tract, sepsis, or other recorded 

and not statistically different 

between groups.

Topic specific outcomes

Hypoxia: NR

Atelectasis: (14 days)

Intervention: 54/685 (7.9%)

Control: 50/701 (7.1%)

Univariate OR 1.11 (95%CI 0.75-

1.66) p=0.60

Adjusted OR

1.13 (95%CI 0.75-1.72) p=0.56

Respiratory Failure (14 days)

Intervention: 38/685 (5.5%)

Control: 31/701 (4.4%)

OR 1.27 (95% CI, 0.78-2.07)

P=0.34

Adjusted OR 1.22 (95% CI,0.74-
Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminated by the Centers for Disease Control and Prevention 

and should not be construed to represent any agency determination or policy. 163

Author 

Year 

(Data 

Extractor)

Risk of 

Bias 

Score

Study 

Objective Population and Setting Intervention Results Comments

Exclusion Criteria: Operations 

performed under general 

anesthesia w/in 30 days, 

chemotherapy for 

malignancy w/in 3 months, 

inability to provide informed 

consent, and preoperative 

arterial hemoglobin oxygen 

saturation below 90% 

without supplemental 

oxygen assessed by pulse 

oximetry

2.03)

P=0.44

Admission to ICU (other than 

normal postop-not statistically 

significant

Gardella 

2008 66

(ES)

RCT

1, 2, 3, 4, 

5, 6, 7, 8, 

9, 10

To test the 

hypothesis 

that highconcentration, 

inspired 

oxygen 

delivered 

during 

cesarean 

delivery and 

for 2 hours 

postoperativel

y decreases 

the incidence 

of surgical site 

infection 

Number of patients: N=143

Patient characteristics: The 

study groups were similar for 

a large number of clinical 

variables, including body 

mass index, maternal 

diabetes, group B 

streptococcus colonization, 

gestational age at delivery, 

and duration of surgery, 

surgical blood loss & 

prophylactic usage of 

antimicrobials. 

Though not statistically 

significant, more patients with 

diabetes mellitus were 

randomized to the intervention 

group.

Hypertensive disorders were 

more prevalent in the control 

group.

Age: 16-47 y

Gender: 100% female

Intervention: n=69

80% Oxygen at 15L/min

Timing of Intervention:

Intra and post-operatively

Duration of Treatment:

From anesthesia induction to 2hrs 

post-operatively.

Device: Covered oxygen blender 

was set to predetermined 

mixture of O2 & air to an adult 

nonrebreathing mask 

Monitoring Intervention:

Venous Blood Gas collection from 

the dorsum of the foot in a 

subset of the high-oxygen group 

Control: n=74

30% oxygen at 15L/min

Standard Preventative Measures:

Skin Prep: Routine surgical 

preparation with betadyne scrub. 

AMP: All but one received 

SSI: Follow up 14 days

Intervention: 17/69 (25%, 15-

35%)

Control: 10/74 (14%, 6-22%)

Relative risk of outcome 

associated with High O2

1.8 (95%CI, 0.9-3.8)P=.12

Cellulitis: 

Intervention: 10/69 (14%)

Control: 7/74 (9%) 

RR (95%CI): 1.5 (0.6-3.8) p=.44

Postpartum endometritis:

Intervention: 9/69 (13%)

Control: 5/74 (7%) 

RR (95%CI): 1.9 (0.67-5.5) p=.26

Wound separation:

Intervention: 5/69 (7%)

Control: 2/74 (3%) 

RR (95%CI): 2.7 (0.5-13.4) p=.26

Subanalysis of SSI risk factors:

Surgical blood loss

Intervention: 900cc (range, 600-

Definitions:

SSI: Administration of intravenous 

antimicrobials for postpartum 

endometritis or oral and 

intravenous antimicrobial for 

wound infection during the 

initial hospital stay or within 14 

days of surgery. Included 

cellulitis as well as deeper 

incisional infections that 

required wound to be opened.

Endometritis: Fever ≥38.5oC within 

the first 24 hours postpartum 

or>38.0oC for at least 4 hours 

after the first 24 post-partum 

associated with uterine 

tenderness greater than 

expected without other 

identified fever sources (Ernest 

2000)

Relative Risk Adjustment- adjusted 

for gestational or chronic 
Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminated by the Centers for Disease Control and Prevention 

and should not be construed to represent any agency determination or policy. 164

Author 

Year 

(Data 

Extractor)

Risk of 

Bias 

Score

Study 

Objective Population and Setting Intervention Results Comments

Obesity: 

BMI median (range): 32 kg/m2 

(22-51)

Comorbidities: NR

Procedure: Cesarean section

Indications: Not Recorded

Setting:1 University Hospital

Location: USA

Dates of Study: October 2001 –

April 2007

Inclusion Criteria: Women who 

underwent a clinically 

indicated caesarian delivery 

after the onset of labor or 

rupture of membranes 

Exclusion Criteria: Cesarean 

delivery before the onset of 

labor or rupture of 

membranes, emergent 

cesarean delivery, general 

endotracheal anesthesia 

(those who started with 

regional anesthetic and 

converted to general were 

not excluded), clinical 

chorioamnionitis, & HIV 

infection

prophylactic antimicrobials. 97 

received it at cord clamp; 45 

received it at case start.

1250)

Control: 800cc (range, 300-1500)

P=0.04

All other factors not statistically 

significant, including 

Intraoperative partial pressure 

of venous oxygen mean and 

range (P=0.91) and 

intraoperative partial pressure 

of venous oxygen >200mmHg 

or ≤200mmHg (P=0.76)

Other infections: NR

Topic Specific outcomes:

Venous Oxygen saturation, 

median % (range)

Intervention: 99 (23-99)

Control: 99 (57-99)

P=0.006

Partial pressure of venous oxygen, 

median mm Hg (range)

Intervention: 177 (20-449)

Control: 122 (20-449)

P=0.001

Surgical Estimated Blood Loss: 

median (range)

Intervention: 900cc (600-1,250)

Control: 800cc (300-1,500) 

p=.04

Reoperation: NR

Length of stay: days median 

(range)

Intervention: 3 (2-5)

Control: 3 (2-6)

p=.92

Mortality: NR

Adverse Events: 

hypertension

Perioperative Care:

Regional not general anesthetic 

(standard for cesarean section 

delivery) 

Other notes: The P-value exceeded 

the P-value for futility 

suggesting these differences 

were unlikely to reach statistical 

significance with continued 

recruitment. The study was 

ended early 

Eight documented protocol 

deviations occurred in each 

group, most due to intermittent 

mask use due to 

nausea/vomiting during surgery 

or patient request post-partum 

to facilitate infant bonding.

Follow-Up: 14 days- All participants 

followed throughout 

hospitalization; of those without 

SSI during initial hospitalization, 

7 controls and 2 interventions 

were lost to 2 week postpartum 

follow up (they were kept in 

analysis and considered to not 

have an SSI)
Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminated by the Centers for Disease Control and Prevention 

and should not be construed to represent any agency determination or policy. 165

Author 

Year 

(Data 

Extractor)

Risk of 

Bias 

Score

Study 

Objective Population and Setting Intervention Results Comments

Readmission:

Intervention: 3/69 (5%)

Control: 2/74 (4%) 

RR (95%CI): 1.4 (0.2-8.4) p=.99

Intravenous antimicrobial

treatment:

Intervention: 10/69 (14%)

Control: 5/74 (7%) 

RR (95%CI): 2.1 (0.8-6.0) p=.17

Belda 

2005 60

(ES)

RCT

1, 2, 3, 4, 

5, 6, 7, 8,

10

To test the 

hypothesis 

that 

supplemental 

oxygen 

reduces 

infection risk 

in patients 

following 

elective 

colorectal 

surgery

Number of patients: N= 291

Patient Characteristics:

Morphometric, demographic, &

other preoperative 

characteristics were similar in 

the 2 treatment groups. 

Except that intervention was 

shorter in height & had more 

women.

Age: Specifics NR = 18-80 years

Gender: m/f

 Intervention: 71/77

 Control: 91/52

Obesity:

BMI: mean (SD): 

 Intervention: 27.1 (4.5)

 Control: 26.5 (3.8)

BMI> 30: 

 Intervention: 26/148 (17.5%)

 Control: 21/143 (14.9%)

Other than percentage of 

inspired FIO2 and resulting 

PaO2 there were no 

significant differences 

between the groups for >30 

other potential intra or 

Intervention: n=148

Intraop: At intubation-Oxygen/ air 

mixture with an FIO2 of 80%. 

Intraop: At extubation increased to 

100% at extubation.

Postop: First 6hrs non-rebreathing 

facemask with reservoir with 

oxygen administered at the 

randomly designated 

concentration (80%) at a total 

flow of 16L/min

Postop after 6 hours-ambient air 

with supplemental oxygen 

provided as necessary to 

maintain pulse oximetry of at 

least 92%

Timing of Intervention: Intra and 

postoperatively

Duration of Treatment:

From anesthesia induction until 6 

hours postoperatively. 

Device: Intraop- intubated; Post-op= 

non-rebreathing face masks w/ a 

reservoir. 

Monitoring Intervention:

SSI (Follow up 14 days)

Total: 57/ 291 (39.3%)

Positive cultures for pathogenic 

bacteria: 50/57

Intervention: 22/ 148 (14.9%)

Control: 35/ 143 (24.4%)

Analysis for increased risk of SSI

80% FIO2 Unadjusted univariate

RR, 0.61; 95%CI 0.38-0.98; P=0.04

80%FiO2: Adjusted multivariate

RR 0.46; CI 95%, 0.22-0.95; P=0.04

(Risk of SSI reduced 54%)

Coexisting Respiratory disease:

Unadjusted univariate

RR 2.15 (95% CI, 1.03-4.48)

Adjusted multivariate

RR 3.23 (95% CI, 1.18-8.86)

P=0.04

ASEPSIS Score >20 on any 

postoperative day:

Intervention: 25 (16.9%)

Control: 37 (25.9%)

P = 0.06

Other infections: NR

Topic specific outcomes:

Partial (arterial) pressure of 

Definitions:

SSI

CDC definitions

Surgical wounds assessed daily by 

blinded surgeon. Purulent 

exudates were cultured & when 

positive for pathogenic bacteria, 

appropriate antimicrobial given.

Wound Healing

Evaluated using ASEPSIS score (>20 

=infection)

Respiratory Disease- - history of 

COPD, asthma requiring routine 

medication or other clinically 

important respiratory impairment. 

Perioperative Care:

Anesthesia induction & treatment 

were standardized across all 

patients.

Blinded attending surgeon 

administered analgesic agents, 

determined initiation of 

feeding, ambulation & the 

duration of hospitalization. 

Other notes: 

Preoperative SSI Risk Stratification:
Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminated by the Centers for Disease Control and Prevention 

and should not be construed to represent any agency determination or policy. 166

Author 

Year 

(Data 

Extractor)

Risk of 

Bias 

Score

Study 

Objective Population and Setting Intervention Results Comments

postoperative confounding 

factors.

Comorbidities:

Respiratory disease:

 Intervention: 25/148 (17.1%)

 Control: 16/143 (11.2%)

PaO2 mmHg 1h post-induction 

 Intervention: 285.9 (96.6%)

 Control: 117.5(40.6%)

P<0.05

PaO2 mmHg 2h post-induction 

 Intervention: 233.7 (89.7%)

 Control: 125.4 (49.0%)

P<0.05

Excepting post-op hemoglobin, 

all other physiological 

variables, lab test results 

dada, ASEPSIS index & 

extrinsic infection risk factors 

were similar between groups.

Postop hemoglobin: mean (SD) 

g/L

Intervention: 11.0 (1.2)

Control: 11.5 (2.5)

P< 0.05

Procedure: Colorectal surgery

 Total or subtotal colectomy: 

11/291 (3.8%)

 Hemicolectomy: 89/291 

(30.6%)

 Rectum resection with 

abdominal-perineal repair: 

29/291 (10.0%)

 Sigmoid anterior resection: 

87/291 (29.9%)

FIO2, pulse oximetry were 

continuously monitored during 

the surgery and in the recovery 

room.

Arterial blood sample obtained 1h 

after anesthesia induction to 

evaluate PaO2; another was again 

2 hours after intubation. 

Control: n= 143

Intraop: At intubation Oxygen/ air 

mixture with an FIO2 of 30%

Intraop: At extubation increased to 

100%.

Postop: First 6hrs non-rebreathing 

facemask with reservoir with 

oxygen administered at the 

randomly designated 

concentration (30%) at a total 

flow of 16L/min

Postop after 6 hours-ambient air 

with supplemental oxygen 

provided as necessary to 

maintain pulse oximetry of at 

least 92%

Standard Preventative Measures:

Mechanical Bowel Prep: using an 

electrolyte solution w/ no 

antimicrobials or antiseptics

AMP: w/ metronidazole plus 

cefoxitin or a 3rd generation 

cephalosporin was administered 

60-90 minutes before the 

surgical incision & continued 

postoperatively for up to 48 

hours. Aminoglycosides used as 

oxygen: 1h postinduction in 

mm Hg:

Intervention: 285.9 (96.6%)

Control: 117.5 (40.6%)

P<0.05

Partial (arterial) pressure of 

oxygen: 2h postinduction:

Intervention: 233.7 (89.7%)

Control: 125.4 (49.0%)

P<0.05

Reoperations: NR

Length of stay: 

Intervention: 11.7 days (7.0) 

(SD??)

Control: 10.5 days (4.4)

P=0.09

Mortality: 

Control: 2 died of multi-organ 

failure of septic origin

Adverse Events

ICU Admission (not planned):

Intervention: 4/148 (2.7%)

Control: 5/143 (3.5%)

P=0.74

SENIC 1/2/3: (%)

Intervention: 19.4/64.2/16.2

Control: 15.4/74.1/10.5

NNIS 0/1/2: (%)

Intervention: 16.9/58.1/25.0

Control: 12.6/68.5/18.9

True ITT analysis was not possible 

cause of incomplete follow up 

date so they conducted a 

sensitivity analysis based on 

treatment group assignment 

that included all patients except 

4 who should have been 

excluded because 2 had 

laparoscopic surgery and 2 had 

low preop albumin

Follow-Up: 14 days after surgery
Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminated by the Centers for Disease Control and Prevention 

and should not be construed to represent any agency determination or policy. 167

Author 

Year 

(Data 

Extractor)

Risk of 

Bias 

Score

Study 

Objective Population and Setting Intervention Results Comments

 Rectal anterior resection: 

53/291 18.2%)

 Other: 22/291 (7.6%)

Indications: 

Cancer 

Intervention: 126/148 (85.8%)

Control: 124/143 (86.7%)

Inflammatory bowel disease 

Intervention: 14/148 (9.4%)

Control: 10/143 (7%) 

Other

Intervention: 7/148 (4.7%)

Control: 9/143 (6.3%) 

Setting: 14 hospitals

Location: Spain

Dates of Study: March 1, 2003 –

October 31, 2004

Inclusion Criteria: Patients 

undergoing elective 

colorectal resection 

(abdominal-peritoneal 

reconstructions)

Exclusion Criteria: Minor colon 

surgery, (polypectomy, 

isolated colostomy), 

laparoscopic surgery, surgery 

less than 1 hour, fever, 

existing signs of infection, 

diabetes mellitus type 1 or 2, 

HIV, weight-loss >20% in the 

previous 3mos, serum 

albumin conc. < 30g/L & a 

leukocyte count < 2500 

cells/mL

an alternative to β-lactam 

antimicrobials in patients who 

reported cephalosporin allergy 

history.

Type and duration of AMP in first 

48hrs similar in the two groups.

Normothermia: Maintained w/ 

circulating-water mattresses & 

forced-air heaters.

Fluids: administered 

intraoperatively at 15mL/kg per 

hour; blood loss restored with 

crystalloids or colloids &, when 

necessary, w/ leukocyte-filtered 

allogeneic red blood cell 

concentrate. Fluid administered 

at 3mL/kg per hour during first 6 

postoperative hours then 

reduced to 2mL/kg per hour after 

transferred to ward.

Wound Closure: They were covered 

with conventional gauze 

bandages. An antiseptic solution 

was applied to the surface of the 

wound but neither 

intraperitoneal antimicrobials 

nor antiseptics were used.

Analgesic: Patients who reported 

post-op pain score of more than 

3cm on a 10-cm visual analog 

scale (0=no pain, 10= worst pain 

imaginable), patient was 

administered an intramuscular or 

IV morphine & non-steroidal 

anti-inflammatory drug.
Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminated by the Centers for Disease Control and Prevention 

and should not be construed to represent any agency determination or policy. 168

Author 

Year 

(Data 

Extractor)

Risk of 

Bias 

Score

Study 

Objective Population and Setting Intervention Results Comments

Pryor 

2004 65

(ES)

RCT

1, 2, 3, 4, 

5, 6, 7, 8, 

9, 10

To determine 

whether the 

routine use of 

high FIO2

during the 

perioperative 

period alters 

the incidence 

of SSI in a 

heterogeneou

s general 

surgical 

population in 

an academic 

setting.

Number of patients: N=160

Patient Characteristics: 

Preoperative patient 

characteristics such as sex, 

age, etc. were recorded and 

not found to be statistically 

significant except for BMI, 

Obesity & Pulse though they 

were not found to be 

indicators of SSI in 

multivariate analysis.

Age: >18y

Gender: NR

BMI mean (SD)

 Intervention: 27.1 (6.7)

 Control: 25.1 (5.0)

 P=0.04

Obesity: BMI>30, No (%)

 Intervention: 19/80 (23.8%)

 Control: 9/80 (11.3%)

 P=0.04

Fifteen obese patients had 

BMI<35. No significant 

difference between groups if 

BMI defined as >32 or >35

Pulse, beats/min (SD)

 Intervention: 83 (14)

 Control: 79 (14)

 P=0.04

Comorbidities:

COPD

 Intervention: 0/80 (0)

 Control: 5/80 (6.3%)

 P=0.06

Minimum temp ,mean (SD) °C

 Intervention: 35.5(0.7)

Intervention: n=80

Intraop:

Pre-oxygenation, induction, 

emergence and extubation: FIO2 

100% 

Intraop: 80% Oxygen (FIO2 of 0.80)

FIO2 could be increased as required 

to maintain arterial oxygen 

saturation >94%. 

Postop Transport from OR: 80% 

Oxygen 10 L/min via closed 

reservoir bag-mask

In recovery extubated: 80% Oxygen 

via a high-flow non-rebreathing, 

humidified, aerosol delivery 

system for 2 hours

In recovery intubated: 80% Oxygen 

through ventilator for 2 h, then 

recovery/ICU team determined 

therapy

Timing of Intervention: Intra and 

postoperatively

Duration of Treatment: During 

surgery and for the first 2 hours 

postoperatively

Device:

During Transport:

Intervention: Closed reservoir bagmask system

Control: Nasal cannula 

In recovery: high-flow 

nonrebreathing, humidified, 

aerosol delivery system with 

selector to provide stable FIO2 to 

the facemask. 

Monitoring Intervention: Pulse 

SSI (Follow up 14 days) No (%)

Overall: 29/160 (18.1%)

Intervention: 20/80 (25%)

Control: 9/80 (11.3%)

P = 0.02

OR 2.63 (95%CI, 1.1-6.2)

RR 2.22(95%CI, 1.1-4.6)

Multivariate analysis : FIO2

(P=0.03) and staying intubated 

at the end of surgery remained 

predictive of infection 

Superficial (Wound only) 

Intervention: 13/20 (65%)

Control: 5/9 (56%)

P = 0.84

Deep structures

Intervention: 3/20 (15%)

Control: 1/9 (11%)

P = 0.84

Wound and Deep structures

Intervention: 4/20 (20%)

Control: 3/9 (33%)

P = 0.84

Time to first detection of infection

Mean (SD) 5.6(2.4) days

Other infections: NR

Topic specific outcomes:

Arterial Oxygen Saturation 

(recovery)

Intervention vs. control p=0.005 

(rank sum analysis) but values 

for both groups well within 

acceptable range (99% [1%] vs. 

98% [2%])

Estimated Blood Loss mL

Definitions:

SSI: SSI was assessed by 

investigator blinded to 

randomization via a 

retrospective chart review 

looking for SSI criteria being met 

at one of two phases: (1) during 

hospitalization and (2) for those 

discharged in <14 days without 

evidence of SSI, then at first 

postop visit with surgeon, any 

emergency department visits, 

telephone calls or other 

contacts within first 14 days 

postop.

SSI Criteria prospectively defined:

1.surgical team clearly documented 

clinical assessment of SSI

2.SSI precipitated management 

action (changing antimicrobials, 

opening wound, aspiration, 

drain placement , further 

surgery

3.clinical assessment supported by 

at least 3 of the following 

objective criteria prospectively 

assigned by the study:

 WBC Count>11000μL

 Temperature>38.5oC

 Radiological Evidence of 

infection

 Extrusion of pus from site

 Positive culture from site

 New erythema and 
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and should not be construed to represent any agency determination or policy. 169

Author 

Year 

(Data 

Extractor)

Risk of 

Bias 

Score

Study 

Objective Population and Setting Intervention Results Comments

 Control: 35.4(0.6)

 P=0.54

Temp at extubation ,mean (SD) 

°C

 Intervention: 36.2 (0.07)

 Control: 36.1 (0.6)

 P=0.20

Procedure: Colectomy (right, 

left, hemicolectomy & 

sigmoid), low anterior 

resection, abdominoperineal 

resection, gastrectomy, 

pancreaticoduidenectomy, 

exploratory laparotomy, and 

large gynecologic staging/ 

de-bulking procedures in 

which bowel or peritoneum 

was involved. 

Indications: 

Cancer

Intervention: 36/80 

Control: 30/80

Non-Cancer

Intervention: 44/80 

Control: 48/80

Setting: University Hospital

Location: NYC, USA

Dates of Study: September 

2001-May 2003

Inclusion Criteria: Patients >18 y 

old undergoing major 

abdominal surgical 

procedures under general 

anesthesia. Laparoscopically 

assisted procedures were 

eligible provided that 

oximetry

Control: n=80

Intraop: Pre-oxygenation, induction, 

emergence and extubation: FIO2 

100% 

Intraop: 35% Oxygen (FIO2 0.35) 

Postop Transport from OR: 35% 

Oxygen at 4 L/min (nasal 

cannula) 

In recovery extubated: 35% Oxygen 

at 4 L/min via a high-flow 

nonrebreathing, humidified, 

aerosol delivery system.

In recovery intubated: 35% Oxygen 

through ventilator for 2 h, then 

recovery/ICU team determined 

therapy

Standard Preventative Measures:

Bowel prep: regimen undertaken 

night before surgery according to 

surgeon’s instructions. AMP 

choice and timing recorded.

AMP: Intravenous antibiotics either 

immediately before arriving or 

upon arrival to operating room 

according to surgeon’s usual 

practice.

 Received AMP: 

 Intervention: 80/80 (100%)

 Control: 78/80 (97.5%)

 P=.26

Admission to hospital: most 

admitted on morning of surgery.

mean (SD) 

Intervention: 230 (180)

Control: 200 (190)

P = 0.03

Crystalloid L:

Intervention: 4.5(2.1)

Control: 3.8(1.9)

P=0.02

Blood loss and Crystalloid not 

significant on multivariate 

analysis

Nitrous oxide 30 min after 

incision mean (SD), %vol/vol

Intervention: 5 (10%) 

Control: 21 (30%) 

P=0.008

Reoperations: 

Intervention: 4/80 (5.0%)

Control: 0/80

P=0.06

Length of stay: mean days (SD)

Intervention: 8.3 (7.5)

Control: 6.4 (4.7)

P= 0.07

SSI: 13.3 (9.9) 

No SSI. 6.0 (4.2) 

P<0.001

Mortality

POD#16 1 Control patient who 

developed an incisional SSI, 

later a deep abscess, had a 

postoperative myocardial 

infarction, followed by a stroke 

and died 

induration that responded 

to treatment of infection

Perioperative Care:

Anesthesia- general- heterogeneity 

in inhalation agents used:

Isoflurane

Intervention: 68.8% Control: 75% 

Sevoflurane

Intervention: 21.3% Control: 

17.5% 

Desflurane

Intervention: 10.0% Control: 7.5%

Other notes:

Preoperative SSI Risk Stratification: 

NNIS M/0/1/2/3

Intervention: 7/32/35/5/2

Control:9/31/34/6/0

P=0.94

NOTE: Initial power analysis does 

not indicate baseline SSI rate. It 

determined that 300 patients 

were needed for a detectable 

treatment effect of 40%. 

Interim analysis was planned to 

be performed after 160 patients 

recruited and study halted if 

P≤0.03. This study represents 

that interim analysis, 

enrollment stopped after 

statistically significant 

difference in SSI rates between 

groups noted.

Follow-Up:

14 days 
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and should not be construed to represent any agency determination or policy. 170

Author 

Year 

(Data 

Extractor)

Risk of 

Bias 

Score

Study 

Objective Population and Setting Intervention Results Comments

laparotomy was performed 

at some point during the 

surgery.

Exclusion Criteria: Exclusively 

laparoscopic procedures, 

patients whose respiratory 

status required an FIO2 in 

excess of 0.35, patients with 

severe chronic obstructive 

pulmonary disease (COPD) 

who were likely to 

experience respiratory 

depression at FIO2 of 0.80 

(minor COPD acceptable), 

patients who were 

hemodynamically unstable 

prior to surgery (systolic 

blood pressure <90mmHg or 

use of vasopressors), patients 

who had received bleomycin 

at any time & patients who 

had an ASA status class 5 or 

5E indicating patient is not 

expected to survive 24 hours 

regardless of the surgery. 

Fully laparoscopic procedures 

were excluded.

Adverse Events:

Pulmonary embolus: 1 

Intervention patient had a 

pulmonary embolus on POD#3 

but recovered without incident

Whitney 

2001 67

(ES)

RCT

1, 10 

To determine 

the effects of 

28% oxygen 

given in the 

first 36 hours 

after surgery 

on tissue 

oxygen levels, 

Number of patients: N=24

Patient Characteristics: Subjects 

compared on coexisting 

conditions, smoking history, 

intraoperative & 

postoperative variables and 

there were no statistically 

significant differences 

Intervention: n=13

Postop: 28% Oxygen delivered at 

rate of 2L/min via nasal cannula

Timing of Intervention:

Postoperative – after discharge from 

recovery and admission to 

surgical unit

Duration of Treatment:

Wound complications:

Clinical healing (assessed through 

self-report and medical chart 

review) showed no significant 

differences between groups. 

Self-report:

Total Wound Problems

Control: 13/ 11 Intervention: 9/ 

Definitions:

SSI: Retrospective medical chart 

review (documentation of 

wound complications to include 

presenting symptoms, wound 

appearance, culture results [if 

any] and prescribed treatment. 

Follow up phone calls with 
Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminated by the Centers for Disease Control and Prevention 

and should not be construed to represent any agency determination or policy. 171

Author 

Year 

(Data 

Extractor)

Risk of 

Bias 

Score

Study 

Objective Population and Setting Intervention Results Comments

collagen 

deposition, 

and clinical 

healing 

outcomes.

between groups.

Age: 18-80 years; Mean (SD)

 Intervention: 41 (9.9)

 Control: 42 (11.5)

Gender: m/f

 Intervention: 69%/31%

 Control: 85%/15%

Obesity:

Body surface area m2:mean (SD)

 Intervention: 2.00 (0.20)

 Control:2.05 (0.30)

Comorbidities: Cardiac History: 

Yes (p=0.084)

 Intervention: 0%

 Control: 7.1%Procedure: 

cervical fusion and/ or 

excision of cervical 

intervertebral disk 

(neurosurgery or the 

orthopedic surgery services)

Indications: NR

Setting: Military regional 

medical center 

Location: Pacific Northwest, USA

Dates of Study: NR (24 month 

period)

Inclusion Criteria: Aged 18-80 

years, male & female, able to 

read & speak English, give 

informed consent, & 

discharged from the postanesthesia care unit without 

supplemental oxygen

Exclusion Criteria: NR

36 hours postop

Device: nasal cannula for delivery of 

the 28% supplemental oxygen for 

intervention

Monitoring Intervention:

Subcutaneous tissue oxygen (PscO2) 

measured via silastic tonometer 

inserted subcutaneously in 

subject’s dorsal left upper arm 

after anesthetic induction. 

Equilibration and baseline 

established while patient on 

room air. Second equilibration at 

30 minutes. PscO2 readings 

recorded at 1, 2, 18, and 36 

hours postoperatively

Wound healing evaluated by 

hydroxyproline content in a 

subcutaneous 

polytetrafluoroethylene tube 

removed on the 7th post-op day

Control: n=11

Room air

Standard Preventative Measures: 

NR

13

Self-report included notation of 

any wound problem, problems 

with wound drainage, 

concerns about incision 

redness, problems with 

incision swelling, incision 

opening, treatment sought for 

wound complications, 

treatment prescribed for 

problem, and pain at surgical 

site that did not decrease over 

time.

Medical Chart Review (30 days)

Complication necessitated clinic 

visit:

Intervention: 0/13

Control: 1/11

Incision redness 

Intervention: 1/12

Control: 1/8

Incision drainage

Intervention: 0/13

Control: 1/8

Incision swelling

Intervention: 0/12

Control: 0/8

Other wound problem:

Intervention: 1/12

Control: 0/8

Wound Healing Assessment

Histology scores for cellularity and 

presence of connective tissue 

or mean amounts of 

hydroxyproline in the ePTFE 

implants- No significant 

patient questioned about 

wound healing problems 

including wound appearance 

and treatment.

Final wound healing classification:

Primary: no wound edge 

separation or other indication of 

wound healing problems.

Secondary: only if patient reported 

partial or complete separation 

of the wound edges or other 

indications of wound healing 

problems and I also confirmed 

by medical record 

documentation

SSI not defined, but wound 

complications and infections (at 

a left or right neck surgical 

wound and in some cases a 

thigh skin graft)were measured 

by three individuals using the

ASEPSIS scoring method 

(comparisons of the ASEPSIS 

method with standard clinical 

definitions of wound infection 

or complications demonstrated 

that ASEPSIS was as sensitive as 

and significantly more specific 

than the other indicators of 

wound problems 

(Wilson 1990))

Perioperative Care: NR

Other notes: NR

Follow-Up: for 30 days post-op via 

medical record review & 
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and should not be construed to represent any agency determination or policy. 172

Author 

Year 

(Data 

Extractor)

Risk of 

Bias 

Score

Study 

Objective Population and Setting Intervention Results Comments

difference between control & 

intervention groups. 

However, only subjects in 

intervention group achieved 

hydroxyproline levels 

>0.40μg/mm of ePFTE tubing.

ASEPSIS Scores- all within 

satisfactory healing (0-10 out 

of 20) without significant 

differences between the mean 

scores.

Wound healing classification: all 

primary healing

Other infections: NR

Topic specific outcomes:

Tissue oxygen mean (SD)

Intervention: 63 mm Hg ±14

Control: 48 mm Hg ±7

P=0.001

No significant effects for time or 

for an interaction between 

time and group.

Reoperations: NR

Length of stay: NR

Mortality: NR

Adverse Effects: NR

telephone call to the subject

Greif 

2000 62

(ES)

RCT

1, 2, 3, 4, 

5, 6, 7, 8, 

9, 10

To test 

hypothesis 

that 

supplemental 

administration 

of oxygen 

during 

perioperative 

period 

Number of patients: N=500

Patient Characteristics: Patient 

clinical characteristics, 

diagnoses, surgical 

procedures, duration of 

surgery, hemodynamic 

values and use of anesthetic 

were recorded & analyzed 

and not found to be 

Intervention: n=250

Intraop: 80% Oxygen and 20% 

Nitrogen after induction of 

anesthesia and intubation. 

Increased 10 100% during 

extubation.

Postop: 80% Oxygen via 

nonrebreathing mask for 2 hours, 

then room air unless additional 

SSI (Follow up 15 days)

Note: Follow up evaluations not 

completed in 3 patients who 

withdrew from the study-they 

had no known infections and in 

analysis were considered 

uninfected.

Overall incidence was 8%

(6% predicted by NNIS scores)

Definitions:

SSI: 

Likely infected: when pus could be 

expressed from the incision or 

aspirated from a loculated mass 

within the wound.

Infected: Wounds with culturepositive pus

(Kurtz 1996)
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and should not be construed to represent any agency determination or policy. 173

Author 

Year 

(Data 

Extractor)

Risk of 

Bias 

Score

Study 

Objective Population and Setting Intervention Results Comments

decreases the 

incidence of 

wound 

infections in 

patients 

undergoing 

elective 

colorectal 

resection.

statistically significant 

between groups except as 

noted. 

Baseline:

Age (y) (±SD)

 Intervention: 57±15

 Control: 57±15

Gender (m/f) 280/220

Obesity:

Weight (kg) Mean ±SD

 Intervention: 74±17

 Control: 72±17

Height (cm) Mean ±SD

 Intervention: 170±12

 Control: 169±12

Comorbidities:

Smoker

Intervention: 24% Control: 

29%

Intraop: End-tidal isoflurane 

concentration-%

 Intervention: 0.90±24

 Control: 0.84±0.24

 P=0.005

 Difference clinically 

unimportant

Procedure: Elective colorectal 

resection

Colon:

Intervention: 71% 

Control: 63%

Rectum: 

Intervention: 29% 

Control: 37%

Indications: 

oxygen required to maintain 

oxyhemoglobin concentrations of 

>92%.

Timing of Intervention:

Intra and Post-operatively

Duration of Treatment:

Intraop and 2 hours postoperatively. 

Device: Postop-Nonrebreathing 

mask sealed to the patient’s face 

and connected to a valved 

manifold and oxygen blender.

Monitoring Intervention:

Intraop: Concentrations of inspired 

oxygen and end-tidal isoflurane 

and carbon dioxide were 

measured

Intraop and postop: Oxygen 

saturation measured with pulse 

oximeters

Arterial blood was obtained 1h after 

induction of anesthesia and 2h 

postop to measure partial 

pressure of oxygen.

Control: n=250

Intraop: 30% Oxygen and 70% 

Nitrogen after induction of 

anesthesia and intubation. 

Increased to 100% during 

extubation.

Postop: 30% Oxygen via 

nonrebreathing mask for 2 hours, 

then room air unless additional 

oxygen required to maintain 

oxyhemoglobin concentrations of 

>92%.

Subgroup Analysis#1 N=54 (1 

Intervention: 13/250 patients 

(5.2%)

(95%CI, 2.4-8)

Control: 28/ 250 patients (11.2%)

(95%CI, 7.3-15.1)

P=0.01

Absolute difference in SSI rates: 

6%

(95%CI, 1.2-10.8)

ASEPSIS Scores mean ±SD

Intervention: 3±7

Control: 5±9

P=0.01

Mixed Effects model: Only use of 

30% oxygen (controls) 

correlated significantly with 

the risk of infection

OR 2.3 (95%CI, 1.2-4.6)

Analysis SSI (N=41) vs. No SSI 

(N=459)

ASEPSIS Scores:

SSI: 25±13

No SSI: 2±4

P<0.001

WBC (X10-3/mm) mean ±SD

Preop- not statistically significant 

difference between groups.

Postop (POD#1, 3, 6, and 9) 

patients with SSI had 

statistically significant higher 

counts (P value range: <0.001-

0.02)

Staples removed (days postop)

SSI: 11.1±2.4

Wound Healing and infection 

Scoring: ASEPSIS (Byrne 1989)

Perioperative Care:

Was anesthesia: standardized and 

induced with IV thiopental 

sodium (3-5mg/kg of 

bodyweight), fentanyl (1-3 

μg/kg) and vecuronium bromide 

(0.1mg/kg) and maintained with 

isoflurane adjusted to keep 

mean arterial blood pressure 

w/in 20% of pre-induction 

value.

Additional fentanyl administered to 

improve analgesia when patient 

emerged from anesthesia.

Other notes: NR

Preoperative SSI Risk 

Stratification: NNIS & SENIC 

(modified)

SENIC 1/2/3 – No. patients

Intervention: 71/158/21

Control: 65/165/20

P=.86

NNISS 0/1/2-No.patients

Intervention: 132/100/18

Control:127/106/17

P=0.86

Initial plan was to study 1000 

patients – evaluate results after 

500—750 patients enrolled. A 

priori criterion of ending the 

study after enrollment of 500 

patients was a difference in 

incidence of SSI between groups 
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and should not be construed to represent any agency determination or policy. 174

Author 

Year 

(Data 

Extractor)

Risk of 

Bias 

Score

Study 

Objective Population and Setting Intervention Results Comments

Cancer: 

Intervention: 65% 

 Control: 55%

Inflammatory Bowel Disease 

(IBS)

Intervention: 20% 

Control: 25%

Other

Intervention: 15% 

Control:20%

Setting: 3 hospitals (2 university)

Location: Austria (2) and 

Germany (1)

Dates of Study: July 1996-

October 1998

Inclusion Criteria: Patients 18-

80 y undergoing elective 

open colorectal resection, 

including those undergoing 

abdominal-peritoneal pullthrough procedures

Exclusion Criteria: Patients 

undergoing minor colon 

surgery (e.g. polypectomy or 

isolated colostomy), recent 

history of fever, infection or 

both, serious malnutrition 

(serum albumin<3.3g/dl, 

WBC <2500 cell/ml3 or loss 

of >20% bodyweight), and 

bowel obstruction.

center)

Intervention: n=22

Control: n=32

Wound collagen and protein 

deposition: near end of surgery, 

7cm expanded 

polytetrafluoroethylene implant 

inserted in subcutaneous tissue a 

few centimeters to one side of 

and parallel to the surgical 

incision- removed on POD#7 and 

assayed for hydroxyproline and 

protein.

Subcutaneous oxygen tension: 

oxygen sensor within 

subcutaneous saline-filled 

tonometer in the lateral upper 

arm. Measurement taken after 

induction of anesthesia and 

continued at designated oxygen 

concentration intraop and 2 h 

postop.

Subgroup Analysis#2 N=24 (1

center)

Intervention: n=12

Control: n=12

Intraop: muscle oxygen tension: 

Oxygen electrode inserted into 

quadriceps femoris (0.35mm 

diameter needle inserted 1mm at 

a time) Oxygen tension recorded 

at each of 200 measurement 

points, histogram constructed for 

each patient. Muscle oxygen 

tension evaluated 90 minutes 

after induction of anesthesia at 

No SSI: 10.3±1.4

P<0.001

Length of stay- see below

Other infections: NR

Topic specific outcomes:

Perioperative administration of 

oxygen in concentrations that 

exceeded those designated:

Intervention: 1/500

Control: 38/500

Mean ±SD

All patients N=500

Arterial oxygen saturation-% 

Intraoperative

Intervention: 99.1±0.6

Control: 98.7±1.1

P=<0.001

Partial pressure of arterial 

oxygen-mm Hg

Intraoperative

Intervention: 348±97

Control: 121±34

P<0.001

Postoperative

Intervention: 206±91

Control: 114±35

P<0.001

Oxygen saturation-% (pulse 

oximetry)

Postoperative

Intervention: 99±2

Control: 97±2

P=<0.001

Subgroup Analysis #1 N=54

with one tailed P<0.012.

Follow-Up: 15 days postop

Wounds evaluated daily until 

discharge then at a clinic visit15 

days)
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and should not be construed to represent any agency determination or policy. 175

Author 

Year 

(Data 

Extractor)

Risk of 

Bias 

Score

Study 

Objective Population and Setting Intervention Results Comments

the designated FIO2.

Standard Preventative Measures:

Bowel Prep: Night before, patient 

underwent standard mechanical 

bowel prep with an electrolyte

solution but no intraluminal 

antimicrobials.

AMP: IV for a mean of 2.7±2.3 days 

after skin incision. Mostly 

metronidazole combined with 

cefazolin, cefamandole, 

amoxicillin, clavulanate or 

mezlocillin. Types and duration 

of AMP were similar in the two 

groups. Fluid-Patients 

aggressively hydrated.

Intraop: Crystalloid 15ml/kg/h IV; 

Blood loss replacement in 

solution to blood ratio 4:1 or 

colloid at2:1.

Postop: Fluids at 3.5ml/kg/h X 24h 

then at 2ml/kg/h X24h. 

Leukocyte depleted blood 

transfusions as deemed 

necessary by surgeon.

Surgical wound treatment (intraop): 

There was no antimicrobial or 

antiseptic irrigation of the wound 

or peritoneal cavity. 

Wound closure: standard – all deep 

layers including peritoneum were 

closed with continuous sutures. 

Subcutaneous tissues were 

closed with interrupted sutures 

& the skin was stapled

Normothermia: Intraoperative core 

Subcutaneous oxygen tensionmm Hg

Intraoperative

Intervention: 109±43

Control: 59±15

P<0.001

Postoperative

Intervention: 73±25

Control: 54±25

P=0.02

Collagen Deposition-ng/mm

Intervention: 258±118

Control: 267±109

P=0.38

Protein Deposition-ng/mm

Intervention 153±91

Control: 163±74

P=0.31

Subgroup Analysis#2 N=24

Muscle oxygen tension-mm Hg

Intervention: 49±10

Control: 25±6

P<0.001

Reoperations: NR

Length of stay:

 Intervention: 12.2±6.1 days

 Control: 11.9±4.0 days

 P=0.26

Length of stay 

SSI (N=41) vs. No SSI(N=459)

SSI: 18.7±8.3 days

No SSI: 11.4±4.1 days

P<0.001

Mortality: Follow up: 15 days
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and should not be construed to represent any agency determination or policy. 176

Author 

Year 

(Data 

Extractor)

Risk of 

Bias 

Score

Study 

Objective Population and Setting Intervention Results Comments

temp was maintained at 36°C 

with use of forced air cover over 

the patient and warming of 

intravenous fluid. Intraoperative 

core temps monitored in the 

distal esophagus; Infrared auralcanal temps or axillary temps 

measured throughout 

hospitalization. Analgesic: 

intravenous & intramuscular 

opioids and administered by a 

study blinded nurse blinded to 

treatment group assignment.

Restarting feeding, staple removal, 

patient discharge determined by 

attending surgeon blinded to

treatment group assignment.

Discharge based on return of bowel 

function, control of any 

infections and adequate healing 

of incision.

Cause of death in most cases was 

sepsis and multi-organ failure.

Intervention: 1/250 (0.4%)

Control: 6/250 (2.4%)

p=0.13

Adverse Effects

Admission to ICU: for surgical 

complications such as 

dehiscence, anastomotic leak, 

* peritonitis.

Intervention: 5/250 (2%)

Control: 12/250 (4.8%)

p=0.14

Q7. What is the optimal target FIO2 to reduce the risk of SSI; how and when should it be administered? Our search did not identify 

RCTs or SRs that both evaluated the optimal fraction of inspired oxygen, how and when it should be administered, and included SSI 

as an outcome. All studies evaluating the use of supplemental increased oxygenation both intraoperative and postoperatively used 

80% FiO2 as the target level. 
Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminated by the Centers for Disease Control and Prevention 

and should not be construed to represent any agency determination or policy. 177

RISK OF BIAS ASSESSMENTS OF STUDIES Q6-7

Randomized Controlled Trials

Author

Year (RefID)

KQ Described 

as 

randomized

Randomization 

appropriately 

performed

Described 

as doubleblind

Outcome 

assessor 

blinded

Study 

participant 

blinded

Investigator 

blinded

Attrition 

described

Attrition smaller 

than 10-15% of 

assigned patients

Attrition 

appropriately 

analyzed

Funding source(s) 

disclosed and no 

obvious conflict of 

interest

Overall 

Risk of 

Bias

Question 6: Oxygenation

Belda

2005 60 6          Low

Bickel

201161 6          Low

Gardella

2008 66 6           Low

Greif

2000 62 6           Low

Meyhoff

2009 63 6           Low

Pryor

2004 65 6           Low

Staehr

2011 64 6           Low

Turtiainen

2011 68 6        Low

Whitney

2001 67 6   High
Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminated by the Centers for Disease Control and Prevention 

and should not be construed to represent any agency determination or policy. 178

Q8-10 ANTISEPTIC PROPHYLAXIS

GRADE TABLE Q8-10

Comparison Outcome

Quantity 

and Type of 

Evidence

Findings Starting 

GRADE

Decrease GRADE Increase 

GRADE

GRADE of 

Evidence 

for 

Outcome

Overall 

GRADE of 

Evidence 

Base

Study Quality

Consistency

Directness

Precision

Publication Bias

Large Magnitude

Dose-response

Confounders

Q8. What are the most effective strategies for preparing the patient’s skin prior to surgery to reduce the risk of SSI?

Q8A. How safe and effective is preoperative antiseptic bathing or showering?

Chlorhexidine 

gluconate (CHG) 

solution

vs. 

placebo

SSI* 1 SR 69

 No difference on meta-analysis of 4 RCTs 70, 71, 72, 

73

 (N=7791) in clean, elective and potentially 

infected procedures: 356/3906 (9.1%) vs. 

389/3885 (10%): RR 0.91 (95%CI, 0.80-1.04).

 No difference on meta-analysis restricted to 2 

higher quality RCTs (Byrne70 and 9547-Rotter72) 

(N=6302): 293/3167 (9.3%) vs. 305/3135 (9.7%); 

RR 0.95 (95%CI, 0.82-1.10)

 Five months into 1 large study 71 the placebo 

was found to have antimicrobial properties and 

was changed but results were not stratified nor 

excluded.

 No difference in each individual trial

 Number preoperative baths, amount of 

antiseptic used per bath, bathing instructions to 

each group, intraoperative antiseptic skin 

preparation agent, use of AMP, and follow up 

varied between studies.

High 0 0 0 0 0 0 0 0 High

High

Product 

related 

adverse 

reactions

1 SR 69

 No difference on meta-analysis of 2 RCTs 70, 73

(N=3589) 9/1804 (0.5%) vs. 10/1785 (0.6%); RR 

0.89 (95%CI, 0.36-2.19).

 Every study used 4% CHG

 Data are driven by the large higher quality RCT 

70 as no allergic reactions were reported in 

either group in the smaller (N=100), lesser 

High 0 0 0 -1 0 0 0 0 Moderate
Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminated by the Centers for Disease Control and Prevention 

and should not be construed to represent any agency determination or policy. 179

Comparison Outcome

Quantity 

and Type of 

Evidence

Findings Starting 

GRADE

Decrease GRADE Increase 

GRADE

GRADE of 

Evidence 

for 

Outcome

Overall 

GRADE of 

Evidence 

Base

Study Quality

Consistency

Directness

Precision

Publication Bias

Large Magnitude

Dose-response

Confounders

quality RCT73.

 1 large study72 (N=1813) not included in the 

meta-analysis also found no difference 

reporting 5 patients in each group with itching 

or reddening of skin.

CHG solution

vs. 

Un-medicated bar 

soap

SSI* 1 SR 69

 No difference on meta-analysis of 3 RCTs 74, 71, 75

(N=1443): 82/752 (10.9%) vs. 94/691 (13.6%); 

RR 1.02 (95% CI, 0.57-1.84)

 Each study used 4% CHG

 Heterogeneity for this comparison was high: 

P=0.08, I2=60%.

 Only the largest (N=1315) RCT 71 reported 

reduction in SSI with 4% CHG: 62/689 (9.0%) vs. 

80/626 (12.8%); RR 0.70 (95% CI, 0.57-0.96); no 

special showering/bathing instructions were 

given to the un-medicated bar soap group 

whereas “great care was taken to ensure that 

the patients using [CHG]...complied with the 

instructions.”

 One (N=66) of the two smaller, lesser quality 

studies74 suggested higher rate of SSI with CHG: 

8/31 (25.8%) vs. 4/35 (11.4%): RR 2.26 (95% CI, 

0.75-6.77) and the other 75 (N=64) showed no 

difference: 12/32 (37.5%) vs. 10/30 (33.3%); RR 

1.13 (95% CI, 0.57-2.21)

 Number preoperative baths, bathing 

instructions, intraoperative antiseptic skin 

preparation agent, use of AMP, procedures, and 

follow up varied between studies.

High 0 0 0 0 0 0 0 0 High High
Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminated by the Centers for Disease Control and Prevention 

and should not be construed to represent any agency determination or policy. 180

Comparison Outcome

Quantity 

and Type of 

Evidence

Findings Starting 

GRADE

Decrease GRADE Increase 

GRADE

GRADE of 

Evidence 

for 

Outcome

Overall 

GRADE of 

Evidence 

Base

Study Quality

Consistency

Directness

Precision

Publication Bias

Large Magnitude

Dose-response

Confounders

CHG solution

vs.

No Wash

SSI* 1 SR 69

 No difference on meta-analysis (N=1142) of 3 

RCTs 75,

73

, 

76: 22/623 vs. 29/519; RR 0.82 ((5% 

CI, 0.26-2.62)

 Each study used 4% CHG

 Heterogeneity for this comparison was 

significantly high: P<0.03, I2= 70%.

 Studies included outpatient and inpatient 

procedures, patients undergoing vasectomy 75, 

plastic surgery of the trunk 73 and elective biliary 

tract, inguinal hernia or breast cancer 

procedures 76, plus differences in SSI definition

 Individual study results differed with only the 

largest (n=978) study 76 favoring 4% CHG: 9/541 

(1.7%) vs. 20/437 (4.6%): RR 0.36 (0.17-0.79), 

the other two suggesting no difference: 12/32 

vs. 9/32; RR 1.33 (95% CI, 0.65-2.72) 75 and 1/50 

vs. 0/50; RR 3.00 (95%CI, 0.13-71.92).

 Despite instructions to not shower, it is not 

clear if the “No wash” groups did in fact shower.

High 0 0 0 -1 0 0 0 0 Moderate Moderate

CHG solution:

Whole body 

vs.

partial body wash

SSI* 1 SR 69

 Reduced risk of SSI with whole body washing in 

1 RCT 76 (N=1093) in elective biliary tract, 

inguinal hernia or breast cancer procedures: 

9/541 (1.7%) vs. 23/552 (4.1%); RR 0.40 (95% CI, 

0.19-0.85).

 Whole body wash = entire body + scalp 

 Partial body wash = restricted to proposed 

surgical site.

High 0 0 0 -1 0 0 0 0 Moderate Moderate
Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminated by the Centers for Disease Control and Prevention 

and should not be construed to represent any agency determination or policy. 181

Comparison Outcome

Quantity 

and Type of 

Evidence

Findings Starting 

GRADE

Decrease GRADE Increase 

GRADE

GRADE of 

Evidence 

for 

Outcome

Overall 

GRADE of 

Evidence 

Base

Study Quality

Consistency

Directness

Precision

Publication Bias

Large Magnitude

Dose-response

Confounders

Aqueous iodophor 

solution vs. control 

(“usual personal 

hygiene routine”)

SSI* 1 RCT 77

 1 RCT (N=114) in elective, clean plastic surgical 

procedures (thorax or abdomen) reported no 

infections in either group (Follow up NR). The 

study was designed to assess impact of 

preoperative showering on skin colonization, 

not SSI.

 Study used 10% povidone iodine solution

High -1 0 -1 -1 0 0 0 0 Very Low Very Low

Q8B. How safe and effective are antiseptic skin preparation agents individually and in combination?

Iodophors

Aqueous Iodophor: 

1-step vs. 2-step

SSI* 2 RCT 78,79

 In a study 78 of 234 oncology surgeries, no 

difference was observed in incisional (10% in 

each group) or intra-abdominal SSI. (2% vs.3%; 

p=0.14) infections (30 day follow up)_

 In a study 79 of 108 CABG patients, no difference 

was observed (12% vs. 13%) in sternal infections 

(6 week follow up)

High 0 0 0 0 0 0 0 0 High High

Aqueous Iodophor 

(1 or 2 step) vs. 

Iodophor in Alcohol 

(1 step, with or 

without adhesive 

drape)

SSI* 5 RCT 80, 81, 

82, 79, 83

 No difference on a meta-analysis (N=626) of 5 

studies: OR: 1.80 (95% CI: 0.50 – 6.52); 

p=0.37

High 0 0 0 -1 0 0 0 0 Moderate Moderate

CHG-alcohol vs. Aqueous Iodophor

CHG-alcohol (1 or 2 

step) vs. Aqueous 

Iodophor (1 or 2 

step)

SSI* 5 RCT 84, 85, 

81, 86, 87

 In a meta-analysis (N=1976) of 5 RCTs, CHGalcohol was associated with reduced risk for SSI: 

OR: 0.59 (95% CI: 0.42 – 0.83); p=0.003

High 0 0 0 0 0 0 0 0 High

High Productrelated 

adverse 

events

2 RCT 85, 86

 One study 85 (N=849) reported 3 (0.7%) drugrelated adverse events (pruritus, erythema or 

both around the surgical wound) in each group 

(P>0.99)

High 0 0 0 0 0 0 0 0 High
Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminated by the Centers for Disease Control and Prevention 

and should not be construed to represent any agency determination or policy. 182

Comparison Outcome

Quantity 

and Type of 

Evidence

Findings Starting 

GRADE

Decrease GRADE Increase 

GRADE

GRADE of 

Evidence 

for 

Outcome

Overall 

GRADE of 

Evidence 

Base

Study Quality

Consistency

Directness

Precision

Publication Bias

Large Magnitude

Dose-response

Confounders

 One study 86 (N=500) reported two cases of skin 

irritation in aqueous iodophor group, and no 

cases in CHG-alcohol group 

CHG-alcohol vs. Iodophor-alcohol

CHG-alcohol (1 or 

2 step) vs. 

Iodophor-alcohol 

(1 or 2 step)

SSI* 5 RCT 88, 89, 

90, 91, 81

 No difference on meta-analysis of 5 RCTs 

(N=1223), OR: 0.64 (95% CI: 0.24 – 1.71); p=0.38 High 0 0 0 0 0 0 0 0 High High

CHG-alcohol 

(2 step) vs. 

Iodophor-alcohol 

(2 step)

SSI* 3 RCT 88, 89, 

90

 No difference among the 743 patients available 

for follow up at 3-4 days in a large (N=866) 

general surgery study90: 27/389 (6.9%) vs. 

35/354(9.9%); p=NS. Significance varied by 

procedure: biliary surgery and “other clean 

operations” each showed lower incidence of SSI 

with CGH-alcohol (p<0.05), in contrast, there 

was a lower incidence of SSI (not statistically 

significant) with iodophor-alcohol in large bowel 

and other laparotomy procedures. 

 No difference in a study 89 of 250 elective, clean, 

plastic surgery breast procedures. Only 4 

superficial SSIs reported at 30 day follow up, all 

in the iodophor-alcohol group (p=0.06)

 No infections reported in either group in a 

small (N=50) study 88 of foot surgeries. The 

study was designed to evaluate the products’ 

efficacy in reducing skin contamination, not SSI

(follow up and definition of SSI not reported).

High 0 0 0 0 0 0 0 0 High High

CHG-alcohol 

(1 step) vs. 

Iodophor-alcohol 

(1 step)

SSI* 2 RCT 91, 81

 In a study of 80 foot/ankle surgeries91, only 1 SSI 

reported (CHG-alcohol group). Follow up and 

definition of SSI not reported. 

High 0 0 0 0 0 0 0 0 High High
Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminated by the Centers for Disease Control and Prevention 

and should not be construed to represent any agency determination or policy. 183

Comparison Outcome

Quantity 

and Type of 

Evidence

Findings Starting 

GRADE

Decrease GRADE Increase 

GRADE

GRADE of 

Evidence 

for 

Outcome

Overall 

GRADE of 

Evidence 

Base

Study Quality

Consistency

Directness

Precision

Publication Bias

Large Magnitude

Dose-response

Confounders

 In a study 81 of 100 arthroscopic shoulder 

surgeries, no infections were reported in either 

group at 10 month follow up.

 Both studies were designed to evaluate the 

products’ efficacy in reducing skin 

contamination, not SSI

Q8C. How safe and effective is the application of an antimicrobial sealant immediately following skin preparation?

Cyanoacrylatebased skin sealant 

vs.

No sealant

SSI*

3 RCT 92, 93, 

94

 No difference on meta-analysis (N=553) of 3 

RCTS in cardiac surgery or hernia repair: OR: 

0.23; 95% CI: 0.04 – 1.22; p=0.08)

High 0 0 0 0 0 0 0 0 High

Adverse High

eventsproduct 

related

3 RCT 92, 93, 

94

 No sensitivity or significant product related 

adverse events.

 In one RCT 94 surgeons reported difficulty 

incising through the clear film in 4/166 patients 

and no difficulty suturing wounds. One report 

of visible “flaking” of the film at the time of 

procedure.

High 0 0 0 0 0 0 0 0 High

Q8D. How safe and effective are plastic adhesive drapes?

Non-iodophor 

impregnated 

adhesive drape 

vs. No drape

SSI* 4 RCT

95, 96, 97, 98

 No difference on meta-analysis of 4 RCTs 

(N=1742) (RR: 1.05; 95% CI: 0.81 – 1.35; p=0.71 High -1 0 0 0 0 0 0 0 Moderate Moderate

Iodophorimpregnated 

adhesive drape 

vs. No drape

SSI* 2 RCT

79, 99

 No difference on meta-analysis of 2 RCTs 

(N=1113) RR: 1.03; 95% CI: 0.66 – 1.60; p=0.89 High 0 0 0 0 0 0 0 0 High High

*Critical outcome; OR: Odds Ratio; RR: Risk Ratio; CI: Confidence Interval
Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminated by the Centers for Disease Control and Prevention 

and should not be construed to represent any agency determination or policy. 184

Comparison Outcome

Quantity 

and Type of 

Evidence

Findings Starting 

GRADE

Decrease GRADE Increase 

GRADE

GRADE of 

Evidence 

for 

Outcome

Overall 

GRADE of 

Evidence 

Base

Study Quality

Consistency

Directness

Precision

Publication Bias

Large Magnitude

Dose-response

Confounders

Q9 How safe and effective is antiseptic irrigation prior to closing the surgical incision?

Antiseptic irrigation

Aqueous 

iodophor 

irrigation vs. 

Normal saline 

Deep SSI* 2 RCT 100,

101

 In meta-analysis (N=660) of 2 studies of clean 

spine surgeries 0.35% povidone iodine 

irrigation (volume not reported) and wound 

soaking for 3 minutes followed by irrigation 

with 2L normal saline was associated with 

reduced risk for deep SSI (OR: 0.08; 95% CI: 

0.01 – 0.58; p=0.01

 In both studies irrigation was completed prior 

to bone grafting and instrumentation. It was 

not repeated prior to wound closure.

 Note: 10/12 (83.3%) were MRSA SSIs. In both 

studies AMP was started preoperatively, redosed intraoperatively as appropriate and 

continued for 5 days postoperatively.

High 0 0 0 0 -1 0 0 0 Moderate

Moderate

Superficial 

SSI*

2 RCT 102, 

103

 In meta-analysis (N=329) of 2 studies in general 

surgical clean-contaminated, contaminated, 

and dirty cases (subpopulations in which both 

study groups were reported to have received 

parenteral AMP), irrigation of the 

subcutaneous tissues for 60 seconds with 10% 

povidone iodine prior to wound closure was 

associated with reduced risk for superficial SSI 

(OR: 0.21; 95% CI: 0.10 – 0.45 p<0.001)

 In meta-analysis (N=149) of cleancontaminated cases, PI associated with 

reduced risk (OR: 0.15; 95% CI: 0.03 – 0.72; 

p=0.02)

High 0 0 0 0 0 0 0 0 High
Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminated by the Centers for Disease Control and Prevention 

and should not be construed to represent any agency determination or policy. 185

Comparison Outcome

Quantity 

and Type of 

Evidence

Findings Starting 

GRADE

Decrease GRADE Increase 

GRADE

GRADE of 

Evidence 

for 

Outcome

Overall 

GRADE of 

Evidence 

Base

Study Quality

Consistency

Directness

Precision

Publication Bias

Large Magnitude

Dose-response

Confounders

 In meta-analysis (N=90) of dirty cases, PI 

associated with reduced risk (OR: 0.26; 95% CI: 

0.08 – 0.91; p=0.03)

Organ/space 

abscess*

3RCT 104, 

105, 106

 In meta-analysis (N=268) of 3 studies, in 

general surgical contaminated and dirty 

abdominal cases no difference noted between 

groups with intraperitoneal lavage using 

povidone iodine (OR: 0.33; 95% CI: 0.08 – 1.34; 

p=0.12) Povidone iodine concentration and 

AMP regimens varied between studies.

 In 1 study 104 in 168 patients undergoing 

laparotomy, peritoneal irrigation with 1 liter of 

1% povidone iodine (0.1% available iodine) for 

60 seconds prior to abdominal closure reduced 

the risk of intra-abdominal abscess formation 

in dirty procedures: 0/36 vs. 6/42; p<0.05 but 

not in contaminated procedures: 1/44 vs. 3/46: 

p=NS

 A subanalysis 105 of peritoneal lavage with 

normal saline then 100ml PI solution prior to 

closure in dirty: 4/13 vs. 5/16; p=NS

 1 study 106 peritoneal lavage with 1L of 10% PI 

solution for 60 sec, repeated 3 times during the 

procedure, the last time before closure in 

contaminated and dirty combined showed no 

difference: 1/37 vs. 4/34; p=0.12.

High 0 -1 0 0 0 0 0 0 Moderate

Adverse 

eventproduct 

related

3 RCT 104,

101, 103

 

 One study 104 in 168 laparotomy patients with 

contaminated peritoneal cavities reported no 

complications from the use of povidone iodine 

were noted.

 One study 101 in 414 mixed spine surgery 

High 0 0 0 0 0 0 0 0 High
Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminated by the Centers for Disease Control and Prevention 

and should not be construed to represent any agency determination or policy. 186

Comparison Outcome

Quantity 

and Type of 

Evidence

Findings Starting 

GRADE

Decrease GRADE Increase 

GRADE

GRADE of 

Evidence 

for 

Outcome

Overall 

GRADE of 

Evidence 

Base

Study Quality

Consistency

Directness

Precision

Publication Bias

Large Magnitude

Dose-response

Confounders

patients reported no product-related adverse 

event with 0.35% povidone iodine followed by 

normal saline irrigation

 One study 103 in 187 general surgical 

procedures reported no allergic reactions

Wound 

healing*

2 RCT 100, 

103

 

 One study 100 in posterior spine (no trauma) 

reported one incidence of wound dehiscence 

event with 0.35% povidone iodine followed by 

normal saline irrigation.

 One Study 103 no evidence of delayed wound 

healing.

High 0 0 0 -1 0 0 0 0 Moderate

Serum 

iodine level

3 RCT 104, 

102, 106 

 One RCT 102: no significant change in serum 

free iodine

 1 RCT106: significant increase in postop serum 

iodine levels at 24h, resolved by 72h, no signs 

of iodine toxicity.

High 0 0 0 0 0 0 0 0 High

Q10. How safe and effective is repeat application of an antiseptic skin preparation agent to the surgical site immediately prior to closing the surgical incision?

Topical antiseptic agents

Aqueous 

iodophor to skin 

prior to wound 

closure vs. no 

topical antiseptic

SSI* 1 RCT 107

 In a lower quality study of 107 gastric or 

colorectal procedures, no difference was 

observed between povidone iodine and no 

topical antiseptic groups for combined or 

individual incisional or organ/space surgical 

site infections:

 Combined: 13/54 (24.1%) vs. 12/53 (22.6%)

 Gastric Organ/Space: p=0.6460

 Gastric Incisional: p=0.4894

 Colorectal Organ/Space: p=0.5898 

 Colorectal Incisional: p=0.6076

High -1 0 0 -1 0 0 0 0 Low Low

Autologous Platelet Rich Plasma
Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminated by the Centers for Disease Control and Prevention 

and should not be construed to represent any agency determination or policy. 187

Comparison Outcome

Quantity 

and Type of 

Evidence

Findings Starting 

GRADE

Decrease GRADE Increase 

GRADE

GRADE of 

Evidence 

for 

Outcome

Overall 

GRADE of 

Evidence 

Base

Study Quality

Consistency

Directness

Precision

Publication Bias

Large Magnitude

Dose-response

Confounders

Autologous 

platelet rich 

plasma-APRP

(gel or spray) vs. 

No APRP

SSI* 3 RCT 

48,49,50

 In a meta-analysis (N=257) of 3 small RCTs in 

cardiac surgery and total knee arthroplasty, 

use of autologous platelet rich plasma was 

not associated with a difference in SSI (OR: 

0.94; 95% CI: 0.42 – 2.13; p=0.89))

 Each individual study did not find a difference

High 0 0 0 -1 0 0 0 0 Moderate

Moderate

Total wound 

closure 1 RCT 49

 At two weeks after surgery, use of a spray 

was associated with decreased likelihood of 

total wound closure (11% vs. 35%; p=0.02)

High 0 0 0 -1 0 0 0 0 Moderate

*Critical outcome; OR: Odds Ratio; RR: Risk Ratio; CI: Confidence Interval
Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminated by the Centers for Disease Control and Prevention 

and should not be construed to represent any agency determination or policy. 188

EVIDENCE TABLE Q8-10

Q8. What are the most effective strategies for preparing the patient’s skin prior to surgery to reduce the risk of SSI?

A. How safe and effective is preoperative antiseptic bathing or showering?

Author 

Year

(Data 

Extractor)

Risk of 

Bias 

Score

Study 

Objective Population and Setting Intervention Results Comments

Veiga

2008 77

(ES)

RCT

1, 4,

To assess the 

influence of 

povidone-iodine 

preoperative 

showers on skin 

colonization in 

elective plastic 

surgery 

procedures

Number of patients: N=114

Patient Characteristics

·Age: mean 38.3 y (range 18-65)

·Gender: m:f: 26:88

·Obesity: NR

·Comorbidities: NR

Procedures: Plastic surgery 

involving the thorax or abdomen: 

Breast reconstruction, reduction 

mammoplasty, augmentation 

mammoplasty, liposuction, 

gynecomasty, scar revision, 

supernumerary mammoplasty, 

and abdominoplasty.

Indications: NR

Setting: 1 school hospital

Location: Brazil 

Dates: September 15, 2004 –

December 1, 2005

Inclusion Criteria: Patients older 

than 18 years scheduled for 

elective and clean plastic surgery 

procedures on the thorax or 

abdomen

Exclusion Criteria: Patients with a 

history of hypersensitivity to 

povidone-iodine, presence of 

rashes, open sores or skin lesions, 

Intervention group: n=57

Patients were instructed to 

shower with liquid detergentbased povidone-iodine 1-% 

and water 2hours before 

surgery. Patients were 

instructed to rinse thoroughly, 

lather with detergent, rinse, 

lather, and rinse again.

Timing of intervention: preop

Duration of intervention:

duration of shower.

Device/agent: Povidone–iodine 

10% detergent-based soap

Monitoring intervention:

Samples for quantitative skin 

sampling were obtained in the 

OR. A 5x10cm area on the 

anterior abdominal wall was 

swabbed with a sterile cotton 

swab pre-moistened with 

sterile saline. Samples were 

processed within 6h after 

obtainment and plated onto 

agar plates.

Control group: n=57

No special instructions for 

showering before surgery 

were implemented. Patients 

followed their usual personal 

hygiene routine on day of 

surgery

SSI (follow up NR)

No SSI seen in either group.

Other infections: NR

Topic-specific outcomes: 

Patients with no 

microorganism growth

 PVP-I: 33/57 (57.9%)

 Control: 0/57

Patients with S. aureus growth 

(13/114 (11.4%)

 PVP-I: 1/57 (1.8%)

 Control: 12/57 (21.1%)

 P=0.0019

Reoperations: NR

Length of stay: NR

Mortality: NR

Adverse events: NR

Definitions: 

NR

Perioperative care: NR

Other notes: NR

Follow-up: NR
Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminated by the Centers for Disease Control and Prevention 

and should not be construed to represent any agency determination or policy. 189

Author 

Year

(Data 

Extractor)

Risk of 

Bias 

Score

Study 

Objective Population and Setting Intervention Results Comments

and antimicrobial use at the time 

of surgery.

Standard preventive measures:

NR 

Webster, 

2011 69

(RA)

SR

1, 2, 3, 4, 

5, 6, 7, 8, 

10, 11

To review the 

evidence for 

preoperative 

bathing or 

showering with 

antiseptics for 

preventing 

nosocomial SSI

Study types: RCT

N: 7 RCT, 10,157 participants

Inclusion criteria: RCTs comparing 

any antiseptic preparation used 

for preoperative full body wash or 

showering, with non-antiseptic 

preparations. 

Exclusion criteria: Quasi-RCTs

Databases searched: Cochrane 

Wounds Group Specialized 

Register, CENTRAL, MEDLINE, 

EMBASE, CINAHL, hand searching, 

reference lists of retrieved articles 

(searches ended OctoberNovember 2010)

Quality assessment: Using the 

Cochrane Collaboration Tool for 

assessing risk of bias, low risk of 

bias for:

Random sequence generation – 5/7 

studies

Allocation concealment – 3/7 

studies

Blinding of investigator and 

participant – 3/7 studies

Blinding of outcome assessor – 5/7 

studies

Incomplete outcome data – 6/7 

studies

Selective reporting – 7/7 studies

Other bias – 4/7 studies

Intervention: Any type of 

antiseptic solution (any 

strength, any regimen, at any 

time before the surgery) used 

for preoperative tub- or bedbathing or showering. All 

studies used 4% chlorhexidine 

gluconate

Comparison: Non-antiseptic 

soap, non-antiseptic soap

solution, no shower or bath

All results intervention vs. 

control – RR (95% CI). No 

significant heterogeneity 

unless specified

SSI:

Chlorhexidine 4% vs. placebo –

all studies (4 studies, 

N=7791): 0.91(0.80-1.04); 

Fixed effects model; I2=0%

Chlorhexidine 4% vs. placebo –

high quality studies (2 

studies, N=6302): 0.95(0.82-

1.10); Fixed effects model; 

I

2

=0%

Chlorhexidine 4% vs. bar soap 

(3 studies, N=1443): 

1.02(0.57-1.84); Random 

effects model; I2=60%

Chlorhexidine 4% vs. no wash 

(3 studies, N=1142): 

0.82(0.26-2.62); Random 

effects model; I2=70%

Chlorhexidine full wash vs. 

partial wash (1 study, 

N=1092): 0.40(0.19-0.85)

Allergic reaction:

Chlorhexidine 4% vs. placebo (2 

studies, N=3589): 0.89(0.36-

2.19); Fixed effects model; 

I

2

=0%

Definitions: SSI definition used by 

the studies was accepted

Follow-up not reported

Funding source – Schools of 

Nursing and Midwifery, Griffith 

University, Brisbane Australia and 

Queensland University of 

Technology, Queensland Australia 

(internal) and NIHR/Department 

of Health (England), Cochrane 

Wounds Group, UK
Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminated by the Centers for Disease Control and Prevention 

and should not be construed to represent any agency determination or policy. 190

B. How safe and effective are antiseptic skin preparation agents individually and in combination?

Author 

Year

(Ref ID_ 

Extractor)

Study 

Design

Qualit

y 

Score

Study Objective Population and Setting Intervention Results Comments

Sistla

2010 84

(ES)

RCT

1, 4, 5, 

6, 7, 9 

To compare the 

efficacy of 

povidone 

iodine and a 

combination of 

chlorhexidineethanol in the 

reduction of 

skin bacterial 

counts and its 

effect on 

wound 

infection rates 

following 

hernia repair.

No. Patients: N=400

Patient Characteristics: Patient 

characteristics & surgical 

elements were similar between 

groups. No statistically 

significant difference. 

All values given for entire study 

group. (N=400)

Age≤60 years: 306 (76.5%)

Age≥60 years: 94 (23.5%)

Gender (m/f): 391/9

Obesity: NR

Side (bilateral/unilateral): 38/362

Comorbidity present: 23 (5.8%)

ASA 3: 9 (2.3%)

Preop Stay

 <48 h: 229 (57.3%)

 >48 h: 171 (42.8%)

Duration of Surgery

 <55 min: 320 (80%)

 >55 min: 80 (20%)

Grade of surgeon

Resident: 378 

(94.5%)Procedures: Open 

Hernia repair

Herniotomy: 18 (4.5%)

Herniorrhaphy: 132 (33%)

Hernioplasty: 250 (62.5%)

Indications:

Suture repair: 62%

Prosthetic repair: 33%

Herniotomy: 5%

Setting: Academic medical 

Intervention: n=200

2.5% chlorhexidine with 70%

ethanol applied in 

concentric circles beginning 

with the site of incision to 

the periphery and allowed 

to dry before the surgical 

site was draped

Timing of Intervention:

Preoperative

Duration of intervention: 

intraoperatively 

Agents: Sterile cotton swabs 

pre-moistened with sterile 

saline, Agent brand name 

for intervention & control 

NR

Monitoring intervention: N/A

Control: n=200

10% povidone-iodine applied 

in concentric circles 

beginning with the site of 

incision to the periphery 

and allowed to dry before 

the surgical site was draped

Standard preventive 

measures

AMP: Patients undergoing 

prosthetic repair 

(hernioplasty) received a 

single dose of cefazolin 

intravenously an hour 

before surgery.

SSI- (30days)

Overall SSI = 33/400 (8.3%)

Intervention: 14/200 (7.0%)

Control: 19/200 (9.5%)

P=0.364Grade of SSI:

Grade 1: Pus Discharge:

12/400 (3%)

Intervention: 5/200 (2.5%)

Control: 7/200 (3.5%)

P=0.538

Grade 2:Erythema, 

induration or cellulitis:

18/400 (4.5%)

Intervention: 8/200 (4%)

Control: 10/200 (5%)

P=0.605

Grade 3: Wound dehiscence:

3/400 (0.8%)

Intervention: 1/200 (0.5%)

Control: 2/200 (1%)

P=0.619

SSI rate in prosthetic repair: 

10.6% vs. suture repair 

(NR) despite use of AMP; 

difference not statistically 

significant.

Univariate analysis Risk of SSI

Operation Side

Bilateral: 8/38 (21%) infected

Unilateral: 25/362(7%) 

infected

Definitions:

Infections: CDC criteria 

Questionnaire: patient selfreported on 1 or more of the 

following conditions: no 

problems, redness and pain 

around the wound which 

settled without treatment, 

redness and pain around the 

wound which required 

antimicrobials, discharge of pus 

from the wound, wound break 

down, need for hospitalization.

Note: patients reported to the 

hospital when they developed 

infection for confirmation and 

treatment due to limited free 

medical facilities.

Perioperative care 

Shaving of operative site was 

done the night before surgery 

on all patients.

Admission preop-patients in this 

series were predominantly 

from distant regions, admitted 

and then operated on next 

available operating day.

Type of anesthesia

Spinal 

Intervention: 172/200 (86%)

Control: 169/200 (84.5%)

Local

Intervention: 28/200 (14%)
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and should not be construed to represent any agency determination or policy. 191

Author 

Year

(Ref ID_ 

Extractor)

Study 

Design

Qualit

y 

Score

Study Objective Population and Setting Intervention Results Comments

institute

Location: India

Dates: NR

Inclusion Criteria: Adults 

undergoing elective open 

inguinal hernia repair

Exclusion Criteria: Patients with 

recurrent or complicated 

inguinal hernia and patients 

with a history of allergy to the 

antiseptics

RR 3.05 (CI 95%, 1.48-6.28)

P= 0.007

Preoperative Stay

>48 hrs. : 22/171(13%) 

infected

<48 hrs. : 13/229(6%) 

infected

RR 2.27 (95% CI, 1.17-4.37)

P=0.019

Duration of surgery

> 55min: 11/80 infected

< 55min: 22/320

RR 2.00 (95%CI, 1.01*-3.95)

P=0.066

Multivariate analysis found 

only preoperative stay to 

be a significant risk factor

(p<0.001) (not age, gender, 

side of hernia, 

comorbidity, ASA score, 

procedure, type of 

anesthesia, grade of 

surgeon or length of 

surgery)

Other infections: NR

Topic Specific Outcomes: 

Not relevant

Reoperations: None of the 

SSIs with pus or wound 

dehiscence necessitated 

removal of the prosthetic 

material (mesh)

Length of Stay: NR

Readmission: NR

Mortality: NR

Control: 30/200 (15%) 

General

Intervention: 0

Control: 1/200 (0.5%)

Dressing: Sterile dressings were 

applied after surgery & wounds 

were left exposed after 48 hr.

Other notes:

NOTE: In Table 1 they indicate 

n=250 (62.5%) hernioplasties 

(prosthetic repair) BUT in the 

results text they state “Sixtytwo percent of patients 

underwent suture repair [which 

should be a herniorrhaphy]; 

prosthetic repair was 

performed in 33% of patient s 

[which is the number of 

herniorrhaphies in table1) 

unclear which is correct.

They also note that higher 

infection rates in developing 

countries vs. others is partly 

due to “certain practices and 

special problems in these 

regions”: shaving, admission 

prior to surgery, poor personal 

hygiene in some of the patients 

in lower socioeconomic strata 

and not practicing antiseptic 

showers preop. 

Follow up: CDC criteria were 

used by investigators to record 

infections in the postoperative 
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and should not be construed to represent any agency determination or policy. 192

Author 

Year

(Ref ID_ 

Extractor)

Study 

Design

Qualit

y 

Score

Study Objective Population and Setting Intervention Results Comments

period. Patients were given a

questionnaire to record/ report 

wound conditions and was 

returned 30 days after surgery. 

(72% of 400 completed the 

questionnaire)

Darouiche 

2010 85

(ES)

RCT

1, 2, 3, 

4, 5, 6, 

7, 8, 9, 

10

To compare the 

efficacy of 

chlorhexidinealcohol with 

that of 

povidoneiodine for 

preventing 

surgical-site 

infections 

No. Patients: 

Intention to treat (ITT) N=849

Per protocol N=813

Patient Characteristics: Patients 

in the two study groups were 

similar with respect to 

demographic characteristics, 

coexisting illnesses, risk factors 

for infection, antimicrobial 

exposure, & duration & types 

or surgery.

All values given for intervention

Intention to Treat intervention 

population n=409

Age yr.; mean (range): 53.3±14.6 

(18-100)

Gender: Male Sex (%) 58.9 

Obesity: NR

Gastrointestinal Disease: 67%

Cardiopulmonary disease: 33.5%

Neurologic disease: 12/5%

Renal disease: 7.3%

Immunologic disease: 4.7%

Cancer: 58.0%

Diabetes mellitus: 15.4%

Liver Cirrhosis: 2.2%

History of Alcohol Abuse: 17.9%

History of smoking: 37.2%

Procedures 

Intervention: 

ITT n=409

Per protocol: n=391

Skin at surgical site was 

scrubbed with an applicator 

that contained 2% 

chlorhexidine gluconate & 

70% isopropyl alcohol. 

More than one 

chlorhexidine alcohol 

applicator was used if area 

exceeded 33 by 33 cm.

Timing of Intervention:

Preoperative

Duration of intervention:

Intraoperatively 

Agents: 

Intervention: 2% 

chlorhexidine gluconate & 

70% isopropyl alcohol

Control: 10% povidone-iodine

Monitoring intervention: N/A

Control: 

ITT: n=440

Per protocol n=422

Skin at surgical site was 

scrubbed and painted with 

an aqueous solution of 10% 

SSI within 30 days

ITT N=849

Any SSI

Intervention: 39/409 (9.5%)

Control: 71/440 (16.1%)

RR 0.59 (95% CI, 0.41-0.85) 

p=0.004

Superficial 

Intervention: 17/409 (4.2%)

Control: 38/440 (8.6%)

RR 0.48 (95% CI, 0.28-0.84) 

p=0.008

Deep Incisional 

Intervention: 4/409 (1%)

Control: 13/440 (3.0%)

RR 0.33 (95% CI, 0.11-1.01) 

p=0.05

Organ/space

Intervention: 18/409 (4.4%)

Control: 20/440 (4.5%)

RR 0.97 (95% CI, 0.52-1.80)

P>0.99

Sepsis from SSI

RR -.62; (95% CI, 0.30-1.29)

Time to onset of SSI longer in

intervention vs. control 

P=0.004

Per-protocol analysis yielded 

Definitions:

SSI diagnosed on basis of CDC 

criteria

Malnutrition: Defined as > 10% 

decrease in weight in over 2 

months

Perioperative care 

NR

Other notes

None

Follow up: 30 days; Surgical site 

assessed 1x/day during 

hospitalization, on discharge & 

at time of follow up & 

whenever SSI occurred. 

Investigators called patients 

1x/week during 30 day followup period.
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and should not be construed to represent any agency determination or policy. 193

Author 

Year

(Ref ID_ 

Extractor)

Study 

Design

Qualit

y 

Score

Study Objective Population and Setting Intervention Results Comments

ITT population N=849

Abdominal: 

 Intervention : 72.6%

 Control : 70.0% 

Colorectal: 

 Intervention: 45.5% 

 Control: 43.4% 

Biliary: 

 Intervention: 10.8% 

 Control: 12.3% 

Small Intestine: 

 Intervention: 10.0% 

 Control: 7.7%

Gastroesophageal: 

 Intervention: 6.4% 

 Control: 6.6%

Non-Abdominal Surgery

 Intervention: 27.4% 

 Control: 30.0% 

Thoracic: 

 Intervention:10.8%

 Control: 13.0% 

Gynecologic: 

 Intervention:10.3% 

 Control:9.1% 

Urologic: 

 Intervention: 6.4% 

 Control:8.0% 

Indications: NR

Setting: 6 University-affiliated 

hospitals

Location: USA

Dates: April 2004-May 2008

Inclusion Criteria: Patients ≥18 

years undergoing cleanpovidone-iodine

(Allowed to dry? NR)

Standard Preventive 

Measures

ITT Population, N=849

AMP: All patients received 

systemic prophylactic 

antimicrobials within 1 hour 

before the initial incision. 

No significant differences in 

the type or number of 

antimicrobials given.

AMP postop 

Intervention :51.7%

Control:48.9$

P=0.41

Shower: 

Preoperative Shower 

Intervention: 26.7%

Control: 27%p=0.94

4% chlorhexidine gluconate

P=0.32

10% povidone iodine

P=0.26

6% triclobarban soap bar

P>0.99

Hair removal- as necessary by 

hair clipping

similar efficacy results.

Other Infections: NR

Topic Specific Outcomes:

ITT population subgroup 

analysis

All Infections by Surgery 

type

Abdominal: 

Intervention: 37/297 (12.5%)

Control: 63/308 (20.5%) 

95% CI for absolute 

difference, -13.9to-2.1 

percentage points

Colorectal

Intervention: 28/186 (15.1%)

Control: 42/191 (22.0%) 

Biliary

Intervention: 2/44 (4.6%)

Control: 5/54 (9.3%) 

Small intestine: 

Intervention: 4/41 (9.8%)

Control: 10/34 (29.4%) 

Gastroesophageal

Intervention: 3/26 (11.5%)

Control: 6/29 (20.7%) 

Non-Abdominal

Intervention: 2/112(1.8%)

Control: 8/132 (6.1%) 

95% CI for absolute 

difference, --7.9 to 2.6 

percentage points

Thoracic:

Intervention: 2/44 (4.5%)

Control: 4/57 (7.0%)

Gynecologic
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and should not be construed to represent any agency determination or policy. 194

Author 

Year

(Ref ID_ 

Extractor)

Study 

Design

Qualit

y 

Score

Study Objective Population and Setting Intervention Results Comments

contaminated surgery 

performed under controlled 

conditions without substantial 

spillage or unusual 

contamination.

Exclusion Criteria: A history of 

allergy to chlorhexidine, alcohol 

or iodophors; evidence of 

infection at or adjacent to the 

operative site; and the 

perceived inability to follow the 

patient’s course for 30 days 

after surgery

Intervention: 0/42

Control: 1/40 (2.5%)

Urologic

Intervention: 0/26

Control: 3/35 (8.6%)

Both the ITT and Per 

protocol analyses showed 

lower rates of SSI in the 

intervention group for 

each of the seven 

operations included.

Trial not powered to 

compare SSI rates for 

subcategories of patients, 

however, SSIs occurred 

significantly less often in 

intervention group for 

small intestinal (P=0.04), or 

abdominal surgery 

(P=0.009) or who did not 

shower preoperatively 

(P=0.02) 

Factors affecting any SSIs

Use of Chlorhexidine (vs. 

PVP-I)

Univariate: OR: 0.55; p=0.004

Multivariate: OR: 0.45 

p=0.004

Use of Abdominal Surgery 

(vs. Non-Abdominal 

Surgery)

Univariate: OR: 4.63; p<0.001

Multivariate: OR: 3.21 

p=0.001
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and should not be construed to represent any agency determination or policy. 195

Author 

Year

(Ref ID_ 

Extractor)

Study 

Design

Qualit

y 

Score

Study Objective Population and Setting Intervention Results Comments

Alcohol Abuse

Univariate: OR: 1.11; p=0.69

Multivariate: OR: 1.12 

p<0.001

Liver Cirrhosis

Univariate: OR: 3.28; p=0.02

Multivariate: OR: 2.14 

p=0.02

Immunologic Disease

Univariate: OR: 2.72; p=0.01

Multivariate: OR: 1.79 

p=0.05

Cancer

Univariate: OR: 2.05; p=0.002

Multivariate: OR: 1.65 

p=0.03

Diabetes Mellitus

Univariate: OR: 1.90; p=0.01

Multivariate: OR: 1.75 

p=0.03

Malnutrition

Univariate: OR: 3.02; p=0.003

Multivariate: OR: 2.62; 

p=0.01

Gastrointestinal Disease

Univariate: OR: 2.96; p<0.001

Multivariate: OR: 1.27 

p=0.05

Days surgical drain in place

Univariate: OR: 1.03; p=0.02

Multivariate: OR1.04 

p<0.001

Preop shower with 

Chlorhexidine (vs. no 

shower)
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and should not be construed to represent any agency determination or policy. 196

Author 

Year

(Ref ID_ 

Extractor)

Study 

Design

Qualit

y 

Score

Study Objective Population and Setting Intervention Results Comments

Univariate: OR: 1.56; p=0.38

Multivariate: OR: 0.95 

p=0.19

Preop shower with PVP-I (vs. 

no shower)

Univariate: OR: 0.135; p=0.01

Multivariate: OR; 0.36 

p<0.001

Use of Chlorhexidine (vs. 

PVP-I)

Univariate: OR: 1.08; p=0.79

Multivariate: OR: 0.96 

p=0.72

Reoperation: NR

Length of Stay: NR

Readmission: NR

Mortality: 

Intervention: 4/391 (1%)

None had SSIs

Control: 3/422 (0.7%)

All 3 died from organ/space 

SSI related sepsis

0.3% (95%CI -0.9-1.5); p

=0.72

Adverse events:

Total Serious adverse events:

Intervention: 72/409 (17.6%)

Control: 70/ 440 (15.9%)

1.7% (95%CI -3.3-6.7); p

=0.52

Bloodstream Infection

Intervention: 11/409 (2.7%)

Control: 23/ 440 (5.2%)

-2.5% (95%CI -5.1-0.1); p
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and should not be construed to represent any agency determination or policy. 197

Author 

Year

(Ref ID_ 

Extractor)

Study 

Design

Qualit

y 

Score

Study Objective Population and Setting Intervention Results Comments

=0.08

Abscess

Intervention: 6/409 (1.5%)

Control: 11/ 440 (2.5%)

-1.0% (95%CI -2.9-0.8); p

=0.33

Pneumonia

Intervention: 6/409 (1.5%)

Control: 9/ 440 (2%)

-0.6% (95%CI -2.3-1.2); p

=0.61

Antiseptic Agent Related 

Adverse Events

Includes pruritus, erythema, 

or both around the surgical 

wound. Intervention: 

3/409 (0.7%)

Control: 3/ 440 (0.7%)

0.1% (95%CI -1.1-1.2); p

>0.99

No cases of fire or chemical 

skin burns in the operating 

room 

Cheng

2009 88

(ES)

RCT

1, 2, 

10

To compare the 

effect of 

povidoneiodine and 

chlorhexidine 

gluconate (both 

with isopropyl 

alcohol) on 

lowering 

bacterial load 

and if any 

No. Patients: N=50

Patient characteristics: No 

Demonstrable difference in 

age, sex or site of operation 

between groups. 

The only demographic 

information given were age and 

gender.

Age y, mean±SD

51.1± 17.4 

Gender m/f: 12/38

Intervention n=25

Skin prepared with 

chlorhexidine gluconate 

0.5% in 70% alcohol) scrub 

and paint

Timing of Intervention: 

Preoperative

Duration of intervention: 

intraoperative 

Agent:

Intervention: 0.5% 

SSI & Adverse events: 

(Follow up NR)

None of the 50 patients 

developed any postoperative infections or 

wound complications

Other Infections: NR

Topic specific outcomes: Not 

relevant

Reoperation: None

Definitions: NR

Perioperative care: NR

Other notes: None

Follow up: No follow up recorded
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and should not be construed to represent any agency determination or policy. 198

Author 

Year

(Ref ID_ 

Extractor)

Study 

Design

Qualit

y 

Score

Study Objective Population and Setting Intervention Results Comments

additional 

benefits 

(additional 

lowering of the 

bacterial load) 

were to be 

gained by an 

additional prescrub with a 

bristled surgical 

brush with 

either of these 

solutions on the 

non-surgical 

foot.

Obesity: NR

Procedures:

Metatarsal osteotomies for 

correction of hallux valgus 

deformity: 23/ 50 (46%)

Removal of osteophytes from the 

first metatarsal: 15/ 50 (30%)

Correction of lesser toe 

deformities: 12/ 50 (24%)

Indications: See Procedures

Setting: 1 Hospital

Location: United Kingdom

Dates: August 2007 – January 

2008

Inclusion Criteria: Undergoing 

foot surgery 

Exclusion Criteria: If there were 

current open wounds, skin 

ulcers and/ or sore, a history of 

onychomycosis, paronychia or 

nail deformity, poorly 

controlled diabetes mellitus or 

recent antimicrobial use (w/in 

one week of surgery)

Chlorhexidine gluconate in 

70% alcohol 

Control: 10% Alcoholic 

tincture of povidone-iodine,

1% available iodine

Monitoring intervention: NR

Control: n=25

Skin prepared with alcoholic 

tincture, povidone-iodine 

10% (1% available iodine) 

scrub and paint

Standard Preventive 

Measures

AMP: All patients were given a 

single dose of a prophylactic 

broad spectrum 

antimicrobial prior to their 

procedure but after skin 

prep.

Length of Stay: NR

Readmission: None

Mortality: None

Saltzman 

2009 81

(ES)

RCT

1, 6, 9 

To examine the 

native bacteria 

around the 

shoulder and 

axilla, and to 

determine the 

efficacy of 

three different 

surgical skinpreparation 

solutions (2% 

No. Patients: N=150

Patient Characteristics:

Characteristics given represent 

the whole study.

Age: 17-79 years old

Gender (m/f): 84/66

Obesity: NRIntervention1:

Heavy Smokers (>1.5 pack per 

day): 1/50

Diabetes mellitus: 4/50

Rheumatoid Arthritis: 0/50

Intervention1 n=50

0.7% iodophor and 74% 

isopropyl alcohol 

Intervention2 n=50

2% chlorhexidine gluconate 

and 70% isopropyl alcohol

Intervention3 n=50

Shoulder prepared with 

povidone-iodine scrub & 

paint 0.75% iodine scrub 

and 1.0% iodine paint

SSI: 10 month minimum

No postoperative infection 

had developed in any of 

the patients in this study at 

a minimum follow-up 

Other Infections: NR

Topic specific outcomes: Not 

relevant

Reoperation: NR

Length of Stay: NR

Readmission: NR

Definitions:

Not recorded

Perioperative care

Hair removal: 37/ 150 (25%) 

reported voluntary shaving of 

axillary hair prior to 

enrollment. All were women. 

12 in control, 9 in 

intervention1, 16 in 

intervention2

Other notes: None
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and should not be construed to represent any agency determination or policy. 199

Author 

Year

(Ref ID_ 

Extractor)

Study 

Design

Qualit

y 

Score

Study Objective Population and Setting Intervention Results Comments

chlorhexidine 

gluconate and 

70% isopropyl 

alcohol; 0.7% 

iodophor and 

74% isopropyl 

alcohol; and 

0.75% iodine 

scrub and 1.0% 

iodine paint)on 

the eradication 

of bacteria 

from the 

shoulder by 

evaluating the 

residual 

bacteria 

present 

following 

surgical skin 

preparation.

History of Alcoholism or 

hepatitis: 4/50

Intervention2:

Heavy Smokers: 0/50

Diabetes mellitus: 6/50

Rheumatoid Arthritis: 2/50

History of Alcoholism or 

hepatitis: 2/50

Control:

Heavy Smokers: 3/50

Diabetes mellitus: 3/50

Rheumatoid Arthritis: 0/50

History of Alcoholism or 

hepatitis: 1/50

Procedures

Arthroscopic Shoulder Surgery= 

137/150 (91.3%)

Shoulder Arthroplasties (primary) 

= 4

Indications: NR

Setting: One hospital

Location: USA

Dates: September 2007 –

February 2008

Inclusion Criteria: Patients 

undergoing shoulder surgery.

Exclusion Criteria: If patient had 

an open wound or a current 

infection or were chronically 

immunosuppressed.

Timing of Intervention

Preoperative

Duration of intervention: 

Intraoperative 

Agent: 

Intervention1: 0.7% iodophor 

and 74% isopropyl alcohol

Intervention2: 2% 

chlorhexidine gluconate and 

70% isopropyl alcohol

Control: Povidone-iodine 

scrub (0.75% iodine scrub 

and 1.0% iodine paint)

Prosthetic implant surgeries

utilized antibacterial-barrier 

(adherent drape)

Monitoring intervention: N/A 

Standard Preventive 

Measures:

Shower: All patients were 

instructed to shower the 

day before the surgery. 

AMP: Preoperative 

antimicrobials were 

administered to all 150 

patients. Arthroscopic or 

soft tissue surgeries 

received cefazolin or 

clindamycin. 

Arthroplasties:

AMP: received the same AMP 

as above plus vancomycin.

Skin Prep: After skin prep 

used an antibacterialimpregnated barriers 

Mortality: NR

Adverse events: NR

Follow up: 10 months
Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminated by the Centers for Disease Control and Prevention 

and should not be construed to represent any agency determination or policy. 200

Author 

Year

(Ref ID_ 

Extractor)

Study 

Design

Qualit

y 

Score

Study Objective Population and Setting Intervention Results Comments

(adhesive drapes) 

Paocharoe

n 

2009 86

(ES)

RCT

1

To study the 

efficacy in the 

reduction of 

bacterial 

colonization 

and 

postoperative 

wound 

infection 

among 

povidoneiodine and 

chlorhexidine 

antiseptic skin 

preparations in 

general surgery 

patients

No. Patients: N=500

Patient characteristics: Age, 

operative time and wound class 

were all analyzed and found to 

not be statistically significant.

Characteristics given represent 

the whole study.

Age 10-60 years old

Age y mean (range) 

 Intervention: 50.5 (18-79)

 Control: 56.2 (20-79)

Gender (m/f): 297/213

Obesity: NR

Operative time hours 

mean (range) 

 Intervention: 1.45 (45min-3hr)

 Control: 1.43 (40 min-3 h)

Wound Classification 

Clean (I)

Intervention: 96 (38.4%)

Control: 87/250 (34.8%)

Clean contaminated (II)

Intervention: 118/250 (47.2%)

Control: 112/250 (44.8%)

Contaminated (III)

Intervention: 46/250 (18.4%)

Control: 51/250 (20.4%)

Procedures: All general surgery

Indications: NR

Setting: One university hospital

Location: Thailand

Dates: June 2006 – November 

2008

Intervention: n=250

4% chlorhexidine in 70% 

isopropyl alcohol scrub (5 

minutes) followed by 4% 

chlorhexidine in 70% 

isopropyl alcohol paint.

Timing of Intervention: preoperatively

Duration of intervention: 

intraoperative 

Agents: 4% chlorhexidine in 

70% isopropyl alcohol 

scrub/4% chlorhexidine in 

70% isopropyl alcohol paint; 

povidone-iodine scrub 

solution and paint.

Monitoring intervention: N/A

Control: n=250

Povidone-iodine scrub 

solution (5 minutes) 

followed by povidone iodine 

paint (Allowed to dry? NR)

Standard Preventive 

Measures: The authors 

allowed other pre-operative 

preparations under the 

standard guideline. What 

these were: NR

Surgical Wound Infection: 

1 month

Total: # (%)

Intervention: 5/250 (2%)

2/5 arteriovenous shunt

2/5 appendectomy

1/5 right half colectomy

Control: 8/250 (3.2%)

4/8 arteriovenous shunt

1/8 modified radical 

mastectomy

2/8 appendectomy

1/8 gastrectomy

For intervention group

RR 1.61 (CI 95%, 1.40-1.81)

Other infections: NR

Topic Specific outcomes: Not 

relevant

Reoperation: NR

Length of Stay: NR

Readmission: NR

Mortality: NR

Adverse events: 2 cases of 

skin irritation from 

povidone-iodine and no 

allergies to chlorhexidine

Definitions: 

SSI: if the wound drained 

purulent material or if the 

surgeon judges it to be infected 

and opens it. (Dunn 2005)

Perioperative care : NR

Follow up: 1 month. Surgical

wounds were examined twice a 

week for the first week and 

every week for 1 month.

Other notes

Numbers were incorrectly 

reported (transposed) within 

results table 2.
Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminated by the Centers for Disease Control and Prevention 

and should not be construed to represent any agency determination or policy. 201

Author 

Year

(Ref ID_ 

Extractor)

Study 

Design

Qualit

y 

Score

Study Objective Population and Setting Intervention Results Comments

Inclusion Criteria: Patients aged 

18-60 years old, with clean 

(class 1), clean contaminated 

(class 2), and contaminated 

wounds (class 3) and ASA class 

1 and 2 scores.

Exclusion Criteria: Patient 

refusal, dirty wounds, 

uncontrolled diabetes, 

immunosuppressive drugs, 

serum albumin levels less than 

3.0 mg/dl, and a history of 

allergic reaction to either study 

agent.

Veiga 

2008 89

(ES)

RCT

1, 

To compare 

povidoneiodine and 

chlorhexidine 

ethanolic 

solutions for 

skin antisepsis 

before elective, 

clean, plastic 

surgery 

procedures.

No. Patients: N=250

Patient Characteristics: 

Characteristics given represent 

the whole study.

Mean operation time:

Intervention: 97.9 min

Control: 107.9 min

Age: >18 years

Gender: NR

Obesity: NR

Procedures: Breast 

reconstruction, mammoplasty, 

breast prosthesis, 

abdominoplasty, scar revision, 

zetaplasty, lipoma exeresis, 

gynecomasty & supernumerary 

mamma

Indications: NR

Setting: 1 hospital

Location: Brazil

Dates: NR

Intervention: n=125

Vigorous scrub with antiseptic 

soap followed by absorption 

with a sterile towel. This 

was followed by skin prep. 

Skin was painted with 

chlorhexidine 0.5% 

ethanolic solution and 

allowed to dry for 2 minutes

Timing of Intervention: 

Preoperative 

Duration of intervention: 

Intraoperative 

Agents: Povidone-Iodine 

10%, or Chlorhexidine 0.5%

Monitoring intervention: 

Patients were followed up 

to 30 days to determine 

postoperative infections

Control group: n=125

Vigorous scrub with antiseptic 

SSI: 30 days

Superficial incisional:

Intervention = 0/125

Control =4/125 (1.6%) 

P= 0.06

Not statistically significant

Other infections: NR

Topic-specific outcomes:

Not relevant

Adverse events: NR

Reoperation: NR

Length of Stay: NR

Readmission: NR

Mortality: NR

Definitions:

SSI: CDC definitions 

Perioperative care 

NR

Other notes

This paper is a “Viewpoints” in 

Plastic & Reconstructive 

Surgery

Follow up: 30 days 
Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminated by the Centers for Disease Control and Prevention 

and should not be construed to represent any agency determination or policy. 202

Author 

Year

(Ref ID_ 

Extractor)

Study 

Design

Qualit

y 

Score

Study Objective Population and Setting Intervention Results Comments

Inclusion Criteria: Patients >18 

years of age, scheduled for 

elective and clean plastic 

surgery procedures.

Exclusion Criteria: NR

soap followed by absorption 

with a sterile towel. This 

was followed by skin prep. 

Skin was painted with 10% 

Povidone-iodine ethanolic 

solution and allowed to dry 

for 2 minutes

Standard Preventive 

Measures: NR

Ellenhorn 

2005 78

(ES)

RCT

1, 2, 

10

To prove the 

equivalency for 

two commonly 

used 

techniques of 

surgical skin 

site 

preparation. 

[The techniques 

are 1) a scrub 

with povidoneiodine soap 

followed by 

paint with 

aqueous 

povidoneiodine OR 2) 

only povidoneiodine paint.]

No. Patients: N=234

Patient Characteristics:

Demographic data (mean age, 

obesity, diabetes, preoperative 

antimicrobial administration, 

and Mean ASA score) were 

analyzed and not found to be 

statistically significant between 

groups (All P≥10).

Age (mean)

 Intervention: 57.7 y

 Control: 60.5 y

Gender: NR

The following characteristics 

given represent the whole 

study.

Obese: 43/234 (18.4%)

Diabetic: 17/234 (7.3%)

ASA score (mean)

Intervention: 2.3

Control: 2.4 

Procedures: Comparable 

between groups except as 

noted

Colorectal: 79/234 (33.8%)

Genitourinary: 38/234 (16.2%)

Intervention: n=119

Patients underwent only 

painting of the operative 

site with aqueous povidoneiodine solution (available 

iodine 1.0%) only.

Timing of Intervention: 

Preoperative

Duration of interventionIntraoperative

Agent: Aqueous povidoneiodine (1.0%) and povidoneiodine detergent (0.75%) 

Monitoring intervention: NR

Control: n=115

Patients underwent a 

vigorous 5-minute scrub 

using urethane sponges 

saturated with povidoneiodine detergent (available 

iodine 0.75%). Detergent 

was then absorbed with a 

blotting towel before 

painting the operative site 

with aqueous povidoneiodine solution (available 

Wound infection-30 days

Intervention: 12/ 119 (10%)

Control: 12/115 (10%)

P=0.078

Other infections

Intra-abdominal infection

Intervention: 2/ 119 (2%)

Control: 4/115 (3%)

P= 0.14

Topic-specific outcomes: NR

Reoperation: NR

Length of Stay: NR

Readmission: NR

Mortality: NR

Adverse events: NR

Definitions:

Infection: defined by clinical 

criteria as presence of wound 

erythema or purulence 

requiring therapeutic 

intervention within the first 30 

days after the surgical 

procedure

Perioperative care:

Hair Removal: A razor was used 

to remove hair from the 

operative site. Other notes: 

None

Follow up: 30 days after surgery.
Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminated by the Centers for Disease Control and Prevention 

and should not be construed to represent any agency determination or policy. 203

Author 

Year

(Ref ID_ 

Extractor)

Study 

Design

Qualit

y 

Score

Study Objective Population and Setting Intervention Results Comments

Pancreaticobiliary: 40/234 

(17.1%)

Upper gastrointestinal: 38/234 

(16.2%)

Intervention: 24/20 (20%) 

Control: 14/115 (12%)

Other*: 39/234 (12.3%)

*Includes retroperitoneal 

sarcoma, lymph node 

dissection, second-look ovarian 

cancer

Clean: 70/234 (29.9%)

Clean-contaminated: 164/234 

(70.1%)

Drain: 67/234 (28.6%)

Indications: malignancy

Setting: cancer center

Location: USA

Dates: NR

Inclusion Criteria: Patients 

undergoing elective abdominal 

operation

Exclusion Criteria: Active 

infection at the time of 

operation, neutropenia defined 

as a white blood cell count of 

<2000 or an absolute 

neutrophil count of <500, 

history of skin reaction to 

iodine and anticipated use of 

prosthetic material as part of 

the surgical procedure.

iodine 1.0%) which was 

allowed to air-dry.

Standard Preventive 

Measures: 

Skin Prep: All patients had all 

gross foreign material 

removed from the skin 

using a dry sponge and tape 

remover, if necessary. 

Shower: Patients were not 

instructed to shower with 

any antibacterial agent 

before the operation.

Non-Standard Preventative 

measures:

AMP: Use of perioperative IV 

antimicrobials was left to 

the discretion of the 

operating surgeon.

AMP given: 

Total: 229/234 (98%)

Intervention: 98%

Control: 97%

Bibbo

2005 87

(ES)

RCT

1, 10

To determine 

the efficacy of 

chlorhexidine 

No. Patients: N=127

Patient characteristics: Patient 

characteristics were recorded 

Intervention: n=60

A 7-minute scrub with 

chlorhexidine gluconate 

SSI (Follow up NR)

No Postoperative wound 

infections developed

Definitions: None

Perioperative care: NR
Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminated by the Centers for Disease Control and Prevention 

and should not be construed to represent any agency determination or policy. 204

Author 

Year

(Ref ID_ 

Extractor)

Study 

Design

Qualit

y 

Score

Study Objective Population and Setting Intervention Results Comments

compared with 

povidoneiodine as a 

preoperative 

skin 

preparation 

agent in 

reducing 

bacterial skin 

contamination 

before clean, 

elective foot 

and ankle 

surgery.

and analyzed and they found 

no differences between the 

two groups

The following characteristics 

given represent the whole 

study.

Mean age (Range): 46 y (16-85y)

Gender (m/f): 61/66

Obesity: NR

Co-morbidities:

Compromised hosts: 35% 

(includes smokers, diabetics, 

history of steroid use, or 

history of MRSA colonization)

Procedures: NR

Indications: NR

Setting: One Hospital

Location: USA

Dates: NR

Inclusion Criteria: Patients with 

intact, uninfected skin having 

clean, elective foot and ankle 

surgery

Exclusion Criteria: Patients with 

open wounds, skin ulcers and/ 

or sores, an active acute or 

chronic infection, or who were 

on active antimicrobial therapy, 

which could alter skin flora.

(4%) and isopropyl alcohol 

(70%) paint. Allowed to dry 

before draping.

Timing of Intervention: 

Preoperative

Duration of intervention:

intraoperative 

Agent: Chlorhexidine 

gluconate (4%) and 

isopropyl alcohol (70%) 

paint; a Povidone-Iodine 

scrub (7.5%); and a 

povidone-iodine paint (10%)

Monitoring intervention: 

Culture swabs were taken 

from all the toes, all webs 

spaces, nail folds, toe 

surfaces, and from the site 

of the proposed surgical 

incision. Patients having toe 

surgery had the dorsal foot 

swabbed as the matching 

site. Swabs were sealed 

and immediately 

transported & processed for 

aerobic, anaerobic, acid 

fast, and fungal cultures

Control: n=67

A 7-minute scrub with 

povidone-iodine (7.5%) and 

painting of the foot and 

ankle with a povidoneiodine (10%) solution. 

Allowed to dry before

draping.

Other Infections: NR

Topic specific outcomes:

Not relevant

Reoperation: NR

Length of Stay: NR

Readmission: NR

Reoperation: NR

Mortality: NR

Adverse events: NR

Other notes: None

Follow up: NR
Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminated by the Centers for Disease Control and Prevention 

and should not be construed to represent any agency determination or policy. 205

Author 

Year

(Ref ID_ 

Extractor)

Study 

Design

Qualit

y 

Score

Study Objective Population and Setting Intervention Results Comments

Standard Preventive 

Measures: 

Shower: No special 

instructions for bathing or 

showering were 

implemented before 

surgery. Patients followed 

their usual personal hygiene 

on the day of surgery.

AMP: Prophylactic 

intravenous antimicrobials 

(cefazolin or vancomycin for 

patients with documented 

penicillin and/or 

cephalosporin allergy) were 

administered in the 20 

minute window before 

incision

Adhesive drapes were not 

used.

Ostrander 

2005 91

(ES)

RCT

1, 7, 8

To assess the 

efficacy of 

three different 

surgical skinpreparation 

solutions (0.7% 

iodine and 75% 

isopropyl 

alcohol; 3% 

chloroxylenol; 

& 2% 

chlorhexidine 

gluconate and 

70% isopropyl 

alcohol) in 

No. Patients: N= 120

Patient characteristics:

The following characteristics 

given represent the whole 

study.

Age y mean (range):48 (19-78)

Gender (m/f): 47/78

Obesity: NR

Comorbidities:

Diabetes:

 Intervention 1: 0

 Intervention 2: 0

 Control: 1/ 40 (2.5%)

Rheumatoid Arthritis

 Intervention 1: 2/40 (5%)

Intervention1: n=40 

3% chloroxylenol

Intervention2: n=40

2% chlorhexidine gluconate 

and 70% isopropyl alcohol

Intervention 3 n=40 0.7% 

iodine and 74% isopropyl 

alcohol

Timing of Intervention: 

Preoperative

Duration of intervention: 

intraoperative 

Monitoring intervention: NR

Control: Each group served as 

its own control for colonies 

Postoperative infection: 

(Follow up-NR)

Total: 3/120 (2.5%)

Intervention1 Chloroxylenol: 

2/40 (5%)

(1 polymicrobial SSI after 

open reduction internal 

fixation (ORIF) calcaneal 

fracture and 1 atypical 

mycobacterium SSI after 

excision of Morton 

neuroma)

Intervention2 Chlorhexidine 

gluconate and alcohol: 

1/40 (2.5%)

Definitions: NR

Perioperative care: All 

procedures performed by one 

surgeon.

Other notes: Power calculation 

not met.

Follow up: NR
Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminated by the Centers for Disease Control and Prevention 

and should not be construed to represent any agency determination or policy. 206

Author 

Year

(Ref ID_ 

Extractor)

Study 

Design

Qualit

y 

Score

Study Objective Population and Setting Intervention Results Comments

eliminating 

potential 

bacterial 

pathogens from 

the foot by 

evaluating the 

residual 

bacterial skin 

contamination 

following 

surgical skin 

preparation.

 Intervention 2: 2/40 (5%)

 Control: 4/40 (10%)

Liver disease:

 Intervention 1: 2/40(5%)

 Intervention 2: 0 

 Control: 2/40 (5%)

Renal issues

 Intervention 1: 1/40 (renal 

insufficiency)

 Intervention 2: 1/ 40 (renal 

transplant)

 Intervention 2: 1/40 (end stage 

renal disease)

 Control : 1/40 (renal failure)

Procedures: Foot and ankle 

surgery

Indications: NR

Setting: One hospital

Location: USA

Dates: October 2002 – May 2003

Inclusion Criteria: Patients 

undergoing foot and ankle 

surgery

Exclusion Criteria: If patients had 

an open wound, abrasion, or 

current infection.

formed (used a more 

proximal tibial site)

Standard Preventive 

Measures: 

Shower: No home cleaning or 

disinfectant protocols were 

utilized prior to surgery.

AMP: All patients received 

intravenously administered 

cefazolin) within one hour 

of the surgical start time.

(Polymicrobial SSI after 

excision of large lipoma at 

lateral heel-portion of 

large tissue flap underwent 

necrosis with subsequent 

development of SSI) 

Control Iodine-alcohol: 0/40

P<1.0

Other infections: NR

Topic Specific Outcomes: NA

Adverse events: NR

Reoperation: NR

Length of Stay: NR

Readmission: NR

Mortality: NR

Segal 

2002 79

(ES)

RCT

1, 2, 5, 

9

To evaluate the 

effect of four 

different skin 

preparations on 

the incidence of 

sternal SSIs in 

patients 

undergoing 

coronary artery 

No. Patients: N=209

Patient characteristics:

Patient demographics were 

compared. 

The following characteristics 

given represent the whole 

study.

All patients had at least one highrisk factor (the basis of the 

Intervention1: n=52

Povidone-iodine five-minute 

scrub with paint

Intervention2: n=50

One-step iodophor/alcohol 

water insoluble film 

Intervention3: n=51

one-step iodophor/alcohol 

water insoluble film with 

Sternal wound Infections: 6 

weeks

Intervention1: 7/52 (13.5%)

Intervention2: 1/50 (2.0%)

Intervention 3: 3/51 (5.9%)

Intervention 4: 7/56 (12.5%)

P=0.117

Infections per treatment

Aqueous Iodine ( 

Definitions

Obesity: BMI>120% of ideal 

weight.

SSI: Clinical exam for signs of 

drainage, redness, tenderness, 

or sternal instability. Sternal 

surgical site exhibiting any of 

these signs was cultured. 

Positive cultures were 
Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminated by the Centers for Disease Control and Prevention 

and should not be construed to represent any agency determination or policy. 207

Author 

Year

(Ref ID_ 

Extractor)

Study 

Design

Qualit

y 

Score

Study Objective Population and Setting Intervention Results Comments

bypass graft 

surgery (CABG) 

who were 

identified as 

high risk of 

developing 

sternal SSI

study). 

39% had 2 risk factors

4% had 3 risk factors

(Percentage numbers appear 

larger in bar graph within paper 

my copy is difficult to read)

Age (y): Mean 

60.9 years (no SD given)

Gender: Over 75% male

Obesity: NR

Redo sternotomies: 11.5%

Procedures performed using the 

IMA: 88.5

Mean±SD

Total OR time: 248 min ±29

Cross clamp time: 42 min±20

Last OR Glucose: 434±210

Procedures: elective CABG 

Surgery

Indications: NR

Setting: 1 tertiary/ teaching 

hospital

Location: USA

Dates: Oct 1, 1994 – April 30-

1997

Inclusion Criteria: Patients 

undergoing elective CABG with 

one or more of the following 

conditions:

Diabetes

Obesity

Chronic Obstructive Pulmonary 

Disease (COPD)

Exclusion Criteria: Patients with 

iodine impregnated surgical 

adhesive drape

Intervention 4: n=56

Povidone-iodine paint

Timing of Intervention: 

Preoperative

Duration of intervention: 

Intraoperative Agents: 

Solutions, insoluble film & 

incise drapes not specified

Monitoring intervention: 

Observation by nurses

Control: 

Standard Preventive 

Measures

Shower

The nurse instructed patients 

to take an antimicrobial 

shower the evening before 

and the morning of surgery, 

or if they were inpatients, 

they were given a 

preoperative antimicrobial 

shower in the hospital. 

Hair removal

If necessary, a qualified 

patient care assistant 

clipped patients’ hair the 

morning of surgery in 

patients’ rooms.

AMP: All patients received a 

prophylactic antimicrobial

(i.e., cefuroxime) or if they 

had a documented allergy 

Intervention 1+4)

14/108 (13.0%)

Insoluble Iodine 

(Interventions 2 and 3)

4/101 (4.0%)

P=0.02

Χ

2

=5.3

Other infections: NR

Topic-specific outcomes: NR

Reoperation: NR

Length of Stay: Uninfected 

patients had a 5-6 day 

shorter length of hospital 

stay than infected patients.

Mortality: NR

Adverse events: NR

correlated with clinical 

evidence according to the CDC 

guideline to indicate a sternal 

SSI

Perioperative care 

NR

Other notes

Impregnated drapes in 

Intervention 3 were shown to 

be ineffective as an 

intervention.

Study deemed underpowered

Follow up: 6 weeks 

postoperatively through 

regularly scheduled clinic visits
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and should not be construed to represent any agency determination or policy. 208

Author 

Year

(Ref ID_ 

Extractor)

Study 

Design

Qualit

y 

Score

Study Objective Population and Setting Intervention Results Comments

an allergy to topical iodine or 

with a preexisting infection 

indicated by a white blood cell 

count higher than 10,000 or by 

a temperature higher than 

100.5oF (38.06oC) because their 

procedures were performed 

emergently.

to penicillin, they received 

vancomycin in appropriate 

dosing window to provide 

adequate coverage at the 

time of incision.

Hort

2002 83

(ES)

RCT

1, 4, 5

To investigate 

the usefulness 

of standard 

surgical 

preparation 

(with 

chlorhexidine 

gluconate 

home scrubs 

and 

preoperative 

povidoneiodine or the 

chlorhexidine 

gluconate 

home scrubs 

plus preoperative 70% 

alcohol) in 

prevention of 

surgical site 

contamination.

No. Patients: N=49

Patient Characteristics: Age, 

gender, weight, co-morbidities: 

NR

Bilateral Procedures: 

 Intervention: 2/23

 Control: 6/26

Procedures: NR

Indications: NR

Setting: 1 Hospital

Location: USA

Dates: NR

Inclusion Criteria: Patients 

undergoing foot or ankle 

surgery

Exclusion Criteria: Total ankle 

arthroplasties

Intervention: n= 25 feet (23 

patients[2 received bilateral 

procedures-]) 

Patient was given two 

chlorhexidine gluconate 

scrub brushes with 

directions to perform two 

separate self-scrubs several 

hours apart before retiring 

to bed the night before the 

operation. In the operating 

room, a 10 minute scrub 

with povidone-iodine 

topical solution was 

followed by painting of the 

foot with povidone-iodine 

topical solution plus the 

addition of a 3-minute 

preoperative preparation of 

the area with 70% alcohol. 

Timing of Intervention:

Preoperatively

Duration of intervention: 

intraoperative Agents: 

Povidone-Iodine solution; 

Scrub Brushes

SSI (Follow up NR)

NO patient in either group 

showed clinical signs of 

wound infection and all 

wounds healed 

uneventfully. 

Other Infections: NR

Topic specific outcomes: NR

Reoperation: NR

Length of Stay: NR

Mortality: NR

Adverse events: NR

Definitions( e.g., SSI) 

Not defined

Perioperative care 

NR

Other notes: If a patient 

underwent a bilateral 

procedure, both feet were 

assigned to the same group.

Follow up: NR
Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminated by the Centers for Disease Control and Prevention 

and should not be construed to represent any agency determination or policy. 209

Author 

Year

(Ref ID_ 

Extractor)

Study 

Design

Qualit

y 

Score

Study Objective Population and Setting Intervention Results Comments

Monitoring intervention: NR

Control: n=32 feet (26 

patients;6 had bilateral 

procedures)

Patient was given two 

chlorhexidine gluconate 

scrub brushes with 

directions to perform two 

separate self-scrubs several 

hours apart before retiring 

to bed the night before the 

operation. In the operating 

room, a 10 minute scrub 

with povidone-iodine 

topical solution was 

followed by painting of the 

foot with povidone-iodine 

topical solution.

Standard Preventive 

Measures

AMP: All patients were given 

one dose of broad-spectrum 

intravenous antimicrobial 

preoperatively (usually 

cefazolin before tourniquet) 

Operative irrigation: Wounds 

were irrigated frequently 

during surgery with an 

antimicrobial solution.

Roberts

1995 82

(ES)

RCT

1, 2, 7, 

8, 9 

To compare the 

efficacy of 2 

commercially 

available skin 

preps: a 

relatively new 

Number of patients: n=200

Patient Characteristics: no 

significant differences in 

patient characteristics between 

groups.

·Age

Intervention group: n=104

1step: patients underwent 1 

step iodophor in water 

application preop. And 

allowed to air dry 

thoroughly for 2-3 min. 1 

SSI (30days)

Overall Infection:

 1step: 10/104 (9.6%)

 2step: 9/96 (9.4%)

 NS

Chest Infection

Definitions: 

Infected Wounds: if purulent 

material drained from the 

incision site. Confirmation of 

infection by a positive culture 

was not necessary.
Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminated by the Centers for Disease Control and Prevention 

and should not be construed to represent any agency determination or policy. 210

Author 

Year

(Ref ID_ 

Extractor)

Study 

Design

Qualit

y 

Score

Study Objective Population and Setting Intervention Results Comments

1-step, 

iodophor in 

alcohol, filmforming, waterinsoluble skin 

prep, versus the 

tradition al 5-10 

minute 

aqueous 

iodophor scrub 

and paint. In 

both groups, an 

iodophorcontaining 

antimicrobial 

incise film was 

also applied on 

the chest. No 

incise film was 

used on the leg.

·Gender

·Obesity

·Comorbidities

Procedures: CABG

Indications: NR

Setting: 1 general hospital

Location: USA

Dates: NR just mentioned a “1 

year period”

Inclusion Criteria: consenting 

adults undergoing CABG 

Exclusion Criteria: if patients 

were allergic to iodine or its 

compounds

unit was used for each 

chest, and each leg.

Timing of intervention: preop

Duration of intervention: NA

Device/agent: aqueous 

iodophor

Monitoring intervention: NR

Control group: n=96

2step: patient underwent a 

traditional 2step starting 

with a 5-10min scrub of 

operative sites (chest and 

legs) with aqueous iodophor 

solution followed by an 

application of an iodophor 

solution. The sites were 

then blotted dry with a 

sterile towel.

Standard preventive 

measures: 

Showers: patients had 

antimicrobial (iodophor) 

showers on the night prior 

to surgery

AMP: Cefuroxime started in 

OR approx. 30 min prior to 

incision and continued 

every 6h for 36h postop.

Hair removal: with clipper.

 1step: 4/104 (3.8%)

 2step: 6/96 (6.3%)

 NS

 Deep Chest Infection

 1step: 0/104 

 2step: 3/96 (3.1%)

Leg Infection: 

 1step: 6/104 (5.8%)

 2step: 5/96 (5.2%)

 NS

Other infections: no 

evidence found for either 

group

Topic-specific outcomes: NR

Reoperations: 

All 3 deep wounds in control 

group required surgical 

intervention.

Length of stay: NR

Mortality: NR

Adverse events: NR

Superficial infected surgical 

wounds: involved the skin, 

subcutaneous tissue or muscle 

located above the fascial layer.

Deep infected surgical wounds: 

involved tissues or spaces at or 

beneath the fascial layer 

including wounds that 

spontaneously dehisced or 

were deliberately opened for 

drainage.

Elderly: 65yo or older

Perioperative care: In both 

groups, an iodophor-containing 

antimicrobial incise film was 

also applied on the chest. No 

incise film was used on the leg. 

Other notes: Small sample size. 

Too small to perform 

multivariate analyses.

Follow-up: 30 days

Gilliam 

1990 80

(ES)

RCT

1, 8, 9

To compare the 

efficacy of a 

traditional skin 

preparation of 

an aqueous 

iodophor 

No. Patients: N=60

Patient characteristics: Age, sex, 

& duration of operation were 

not statistically significantly 

different between groups.

Age (average), y:

Intervention: n=30

Skin was prepared with a onestep application of a waterinsoluble iodophor-inalcohol solution applied as 

paint. Skin was allowed to 

SSI (follow up NR)

None of the patients became 

infected

Other Infections: No 

Infections

Topic Specific Outcome:

Definitions:

NR

Perioperative care 

Hair Removal: All hair was 

removed by dry shave just prior 
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and should not be construed to represent any agency determination or policy. 211

Author 

Year

(Ref ID_ 

Extractor)

Study 

Design

Qualit

y 

Score

Study Objective Population and Setting Intervention Results Comments

consisting of a 

five-minute 

scrub-and-paint 

AND a sterile 

nonantimicrobial 

plastic surgical 

adhesive 

drapes. With 

the efficacy of a 

single 

application of a 

water-insoluble 

iodophor-inalcohol solution 

AND a sterile 

nonantimicrobial 

plastic surgical 

adhesive 

drapes.

 Intervention: 65y

 Control: 61y

Gender (m:f):

 Intervention: 11:19

 Control: 8:22

Obesity: NR

Length of Operation (average), 

Min (range):

 Intervention: 135 (30-310)

 Control: 130 (160-300)

Procedures: Primary or revision 

total hip or total knee 

arthroplasty 

Indications: NR

Setting: 1 hospital

Location: USA

Dates: NR

Inclusion Criteria: Patients 

undergoing clean total joint 

surgery.

Exclusion Criteria: NR

dry before covering the 

surgical area with a sterile, 

non-antimicrobial plastic 

surgical adhesive drapes.

Timing of Intervention: 

Preoperative

Duration of intervention: 

Intraoperatively

Agent Water-insoluble 

iodophor-in-alcohol solution

Monitoring intervention: For 

liquid skin prep NR except 

for surgical adhesive drape, 

where adhesion to the skin 

was evaluated by the 

operating surgeon prior to 

wound closure

Control: n=30

Skin was prepared with a 

traditional five-minute 

aqueous iodophor scrub 

followed by the application 

of an aqueous iodophor 

solution as paint. Skin was 

allowed to dry before 

covering the surgical area 

with a sterile, nonantimicrobial plastic surgical 

adhesive drapes.

Standard Preventive 

Measures

Preop Shower: All patients 

showered the night before 

surgery with chlorhexidine 

gluconate soap.

Drape Lift: (yes or no 

phenomenon)

 Intervention: 0/30

 Control: 12/30 (40%)

P<0.01

Reoperation: NR

Length of Stay: NR

Readmission: NR

Mortality: NR

Adverse events: NR

to preparing the skin. 

Other notes

Intervention was found to 

increase incise drape adhesion, 

particularly at the wound 

edges.

Follow up: NR
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and should not be construed to represent any agency determination or policy. 212

Author 

Year

(Ref ID_ 

Extractor)

Study 

Design

Qualit

y 

Score

Study Objective Population and Setting Intervention Results Comments

Environmental: Surgery was 

conducted under a 

horizontal unidirectional 

laminar air-flow system.

Dewan

1987 99

(ES)

RCT

1, 2, 4 

7, 8

To determine if 

skin organism 

contamination 

of the wound 

made through 

iodophor 

impregnated 

incise drapes 

should be 

reduced and 

less than when 

a standard skin 

preparation is 

used. Thus if 

contamination 

is significantly 

linked to 

infection, a 

reduction in the 

wound 

infection rate 

from skin 

organisms 

should follow.

Number of patients: N=1016

Patient Characteristics: 

satisfactory randomization for 

the non-parametrically 

distributed groups was 

confirmed for each of the 

major wound infection risk 

factors and excluded a bias 

from these.

·Age

·Gender

·Obesity

·Comorbidities

Procedures: general abdominal 

operations including inguinal 

hernia repair

Indications: NR

Setting: One university hospital

Location: New Zealand

Dates: August 1983 – May 1985

Inclusion Criteria: Patients 

undergoing abdominal 

operation, including inguinal 

hernia

Exclusion Criteria: patients under 

10 years of age and patients of 

one surgeon when he felt the 

color of the drape precluded 

optimal incision placement. 

Also, patients requiring 

abdominoplasty and two 

Intervention group: n=529

Patients with iodophorimpregnated drape applied

Timing of intervention: 

perioperatively.

Duration of intervention: 

surgery

Device/agent: Iodophorimpregnated drape

Monitoring intervention: NA

Control group: n=487

Patients where no iodophorimpregnated drape was 

used.

Standard preventive 

measures: Routine skin 

prep of an iodophor 

antiseptic followed by 

alcohol. The operative field 

was dried with a sterile 

swab.

SSI: 

Wound infection

 Intervention: 36/529 (6.8%)

 Control: 34/487 (7.0%)

 Not significantly different

Other infections: NR

Topic-specific outcomes: NR

Reoperations: NR

Length of stay: NR

Mortality: NR

Adverse events: NR

Definitions:

Infection: present if wound 

discharged pus or if the 

discharge of fluid from the 

wound was as associated with 

appositive bacterial culture. 

Infection was also diagnosed if 

the wound showed erythema 

more than 1cm lateral to the 

wound margin, and for either 

one third of the length of the 

wound or an 8cm length of it. 

Perioperative care: NR

Other notes: None

Follow-up: 3weeks follow up
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and should not be construed to represent any agency determination or policy. 213

Author 

Year

(Ref ID_ 

Extractor)

Study 

Design

Qualit

y 

Score

Study Objective Population and Setting Intervention Results Comments

patients with a strong history 

of previous iodine allergy.

Berry

1982 90

(ES)

RCT

1, 2, 6, 

7, 8, 9 

To compare the 

effect of 

alcoholic 

povidoneiodine and 

alcoholic 

chlorhexidine 

(both as skin 

prep and 

surgical scrub) 

on the 

incidence of 

postoperative 

wound 

infection in a 

general surgical 

unit

No. Patients: N=866

Patient Characteristics: 

Operative & demographic 

information was deemed 

similar between study groups. 

Details not reported

Age: 

<15 years

 Intervention: 4 (0.9%)

 Control: 4 (1.0%)

15-64 years

 Intervention: 338 (74.6%)

 Control: 309 (74.8%)

≥65 years 

 Intervention: 112 (24.7%)

 Control: 100 (24.2%)

Gender: NR

Obesity: NR

Procedures, No (%): (N=886)

Operations on biliary tract: 167 

(18.8%)

Large bowel operations: 61 

(6.9%)

Other laparotomy operations: 96 

(10.8%)

Hernia/genitals/varicose veins 

338 (38.1%)

Other ‘clean’ non-abdominal: 204

(23.0%)

Indications: NR

Setting: 1 hospital

Location: United Kingdom

Dates: May 1978 – February 1980

Intervention: n=453

Two applications of 0.5% 

chlorhexidine alcohol. Skin 

preparation solution was 

applied with sterile sponges. 

Timing of Intervention: 

Preoperative

Duration of intervention: 

Intraoperatively

Agent: povidone iodine 10% 

in alcohol or 0.5% 

chlorhexidine in spirit

Monitoring intervention: NA

Control: n=413

Two applications of povidoneiodine 10% in alcohol. Skin 

preparation solution was 

applied with sterile sponges.

Standard Preventive 

Measures

Surgical hand Scrub: A sterile 

brush was used to scrub the 

hands, paying particular 

attention to the areas under 

the nails and in the nail 

folds. The forearms were 

washed as far as the elbow. 

Skin was scrubbed for 4-5 

minutes as recommended.

 Control: Scrub solution was 

alcoholic povidone-iodine 

(10% available iodine)

SSI – (Follow up: not clearwound assessed 3-4 days 

postop and at discharge)

More than one type of 

abnormality reported on 

some wounds

Wound abnormality: Any 

abnormality agreed by 

both observers at 

discharge, all operations

Any wound abnormality

 Intervention: 44/453 (9.7%)

 Control: 61/413 (14.8%)

 Χ

2

(1)= 4.7, P=0.03

Biliary tract

 Intervention: 6/90 (6.7%)

 Control: 15/77 (19.5%)

 Χ

2

(1)= 5.1, P<0.05

Other clean operations

 Intervention: 2/105 (1.9%)

 Control: 13/99 (13.1%)

Χ

2

(1)= 7.9, P<0.05

Differences in procedures 

below, not statistically 

significant:

Large Bowel

 Intervention: 5/28 (17.9%)

 Control: 3/33 (9.1%)

Other Laparotomy

 Intervention: 15/49 (30.6%)

 Control: 9/47 (19.1%)

Hernia, genitalia, veins

 Intervention: 16/181 (8.8%)

Definitions:

No definitions, wounds were 

judged at evaluator’s discretion 

as normal, erythematous, 

edematous, discharging or 

purulent. Moist wounds were 

swabbed & cultured for both 

aerobic (Cowan 1974) & 

anaerobic (biochemical tests) 

organisms

Perioperative care : NR

Other notes: None

Follow up: Wounds were 

assessed independently by one 

member of the nursing staff 

and one member of the 

medical staff at a “standard” 

period of 3-4 days postoperatively and then at 

discharge

. If patient was discharged before 

the 3rd day was assessed just 

prior to leaving the hospital.
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and should not be construed to represent any agency determination or policy. 214

Author 

Year

(Ref ID_ 

Extractor)

Study 

Design

Qualit

y 

Score

Study Objective Population and Setting Intervention Results Comments

Inclusion Criteria: All elective 

surgical cases

Exclusion Criteria: Patients 

known to be sensitive to either 

skin preparation utilized in this 

study.

 Intervention: Scrub solution 

was alcoholic chlorhexidine 

with .5% available 

chlorhexidine.

Hair removal: Skin shaving 

was routinely performed on 

hairy skin 18-24 hours 

preoperatively

Non-Standard Preventive 

Measures:

Antimicrobial Prophylaxis

Only patients undergoing 

colonic & rectal surgery 

received metronidazole 3 

times daily and neomycin 

four hourly for 3 days. 

Bowel Prep: Routine bowel 

prep was used only in large 

bowel surgery.

 Control: 21/157 (13.4%)

Wound abnormalities: 

Specific abnormality 

agreed by both observers 

at discharge, all 

operations

Redness of wound:

 Intervention: 16/453 (3.5%)

 Control: 21/413 (5.1%)

Swelling of Wound:

 Intervention: 12/453 (2.6%)

 Control: 12/413 (2.9%)

Discharge from wound:

 Intervention: 16/453 (3.5%)

 Control: 21/413 (5.1%)

Pus from wound:

 Intervention: 13/453 (2.9%)

 Control: 22/413 (5.3%)

Any abnormality agreed by 

both observers 3-4 days 

postop (Note: *64 

intervention and 59 

control patients were 

discharged before 3 days, 

therefore the total 

population for results 

below is:

Intervention: n=389

Control: n=354Infection was 

slightly more common 

overall in the control group 

but the difference was not 

statistically significant:

Total wound abnormalities
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and should not be construed to represent any agency determination or policy. 215

Author 

Year

(Ref ID_ 

Extractor)

Study 

Design

Qualit

y 

Score

Study Objective Population and Setting Intervention Results Comments

 Intervention: 27/389 (6.9%)

 Control: 35/354 (9.9%)

Biliary tract

 Intervention: 2/90 (2.2%)

 Control: 8/76 (10.5%)

Large Bowel

 Intervention: 3/28 (10.7%)

 Control: 0/31 

Other Laparotomy

 Intervention: 7/49 (14.3%)

 Control: 5/47 (10.6%)

Hernia, genitalia, veins

 Intervention: 13/157 (8.3%)

 Control: 16/150 (10.7%)

Other clean operations 

 Intervention: 2/65 (3.1%)

 Control: 6/50 (12.0%)

Any abnormality recorded 

by one or both observers 

3-4 day postop (i.e. 

disagreement between 

observers)

Total wound abnormalities

 Intervention: 41/389 

(10.5%)

 Control: 44/354 (12.4%)

Biliary tract

 Intervention: 4/90 (4.4%)

 Control: 11/76 (14.5%)

 Χ

2

(1)= 3.9, P<0.05

Overall infection rate for 

“clean” operations 

(excluding colonic & 
Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminated by the Centers for Disease Control and Prevention 

and should not be construed to represent any agency determination or policy. 216

Author 

Year

(Ref ID_ 

Extractor)

Study 

Design

Qualit

y 

Score

Study Objective Population and Setting Intervention Results Comments

biliary): 11.9%

Infection/ abnormality rates 

varied between surgeries 

and groups. NO overall 

statistically significant 

advantage for either group 

emerged for an all-purpose 

skin prep solution.

Other Infections: NR

Topic Specific Outcomes: NA

Reoperation: NR

Length of Stay: NR; Analysis 

of the date for each group 

showed no significant 

difference between the 

preparations in the mean 

length of patients’ stay in 

the hospital

Readmission: NR

Mortality: NR

Adverse events: NR

Psaila

1977 98

(ES)

RCT

1, 8, 9

To assess the 

role of adhesive 

plastic skin 

drapes and 

plastic ring 

wound 

protectors in 

the prevention 

of wound 

infection 

following 

abdominal 

surgery

Number of patients: N=144 

(n=98 utilized here)

Patient Characteristics:

·Age

·Gender

·Obesity

·Comorbidities

Procedures: abdominal surgery.

Indications: NR

Setting: One University hospital

Location: United Kingdom

Dates: NR

Inclusion Criteria: Patients 

undergoing abdominal surgery

Intervention group: N=51

An adhesive plastic drape was 

applied over cloth towels at 

the abdominal surgery site.

Timing of intervention

Duration of intervention

Device/agent

Monitoring intervention

Control group: n=47

Cloth towels were applied to 

the abdominal wound

Standard preventive 

measures: 

Skin prep: 1 in 30, 0.05% 

SSI 

Wound infection:

All: 26/144 (18.0%)

 Drape: 8/51 (16%)

 No Drape: 10/47 (21%)

Other infections: NR

Topic-specific outcomes: NR

Reoperations: NR

Length of stay: NR

Mortality: NR

Adverse events: NR

Definitions: 

Presence of infection: 

1) Erythema around the 

sutures or along the 

wound edge with an 

accompanying pyrexia

2) Discharge of exudate or 

pus from the wound

3) Wound breakdown.

4) If infection was 

considered to be 

present, a swab was 

taken and sent. 

Perioperative care: NR
Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminated by the Centers for Disease Control and Prevention 

and should not be construed to represent any agency determination or policy. 217

Author 

Year

(Ref ID_ 

Extractor)

Study 

Design

Qualit

y 

Score

Study Objective Population and Setting Intervention Results Comments

Exclusion Criteria: Patients 

receiving preoperative 

antimicrobials (with exception 

of non-absorbable 

sulphonamides used for bowel 

prep)

chlorhexidine and cetrimide 

0.5% and Chlorhexidine 

gluconate 0.5% in alcohol.

Other notes: None

Follow-up: daily after the 3rd

postoperative day.

Jackson

1971 97

(ES)

RCT

1, 2

To conduct a 

study to 

determine the 

effectiveness of 

plastic adhesive 

drapes in 

preventing 

wound 

infection.

Number of patients; n=921

Patient Characteristics: 

Recorded, not reported by 

study group.

·Age

·Gender

·Obesity

·Comorbidities

Procedures: NR

Indications: NR

Setting: 1 hospital

Location: England

Dates: Started December 1967 –

two years later.

Inclusion Criteria: All suitable 

cases operated on by one of 

the 3 authors or 2 other 

surgeons. 

Exclusion Criteria: Operations 

where drapes could not be 

used satisfactorily 

(mastectomy, perineal 

operations, amputation, limb 

arterial surgery, etc.); known 

iodine sensitivity, cases where 

difficulties with adhesiveness of 

drapes were present or where 

drapes were unsatisfactory.

Intervention group: n=473

Patients who had a plastic 

adhesive drape utilized at 

the site of surgery

Timing of intervention: 

Intraoperative

Duration of intervention: 

until just after incision.

Device/agent: Plastic 

adhesive drape.

Monitoring intervention: NA

Control group: n=448

Patients who had no adhesive 

drape utilized.

Standard preventive 

measures:

Skin prep: swab soaked in 

2.5% alcoholic solution of 

iodine BP was used to paint 

the operation area. This was 

wiped dry and ether was 

painted around the area of 

the incision. 

SSI: 

Wound infection

 Drape: 67/473 (14.2%)

 No Drape: 52/448 (11.6%)

 P>0.20

Other infections: NR

Topic-specific outcomes: NR

Reoperations : NR

Length of stay: NR

Mortality: NR

Adverse events: NR

Definitions : 

Wound infection: defined in 

terms of the discharge of pus 

from the wound. Usually a 

small amount (e.g., the socalled stitch abscess), but 

sometimes a wound abscess 

developed which required 

evacuation by removal of a 

suture and spreading of the 

wound edges. Wherever 

possible, the infecting organism 

was isolated and the cause was 

assessed. If a swab grew a 

microorganism, but no pus was 

produced, the wound was not 

regarded as infected. The slight 

moistness at the site of a 

drainage tube was not 

accepted by itself as an 

indication of infection.

Perioperative care: NR 

Other notes: None

Follow-up: at least 4 weeks.
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and should not be construed to represent any agency determination or policy. 218

Author 

Year

(Ref ID_ 

Extractor)

Study 

Design

Qualit

y 

Score

Study Objective Population and Setting Intervention Results Comments

C. How safe and effective is the application of an antimicrobial sealant immediately following skin preparation?

Author 

Year

(Ref ID_

Extractor)

Study 

Design

Qualit

y 

Score

Study 

Objective Population and Setting Intervention Results Comments

von 

Eckardstei

n

2011 92

(ES)

RCT

1, 2, 6, 

7, 8, 9 

To determine 

if the use of 

cyanoacrylate

-based skin 

sealant 

before 

coronary 

artery bypass 

grafting 

(CABG) could 

reduce 

surgical 

wound 

contaminatio

n by skin 

microflora 

and decrease 

postprocedure 

infections. 

Number of patients: N=293

Patient Characteristics: 

There was no significant 

difference between 

groups except in 

occurrence of obesity (see 

below)

·Age: y mean (SD)

 Intervention: 63.2 (8.53)

 Control: 62.9 (9.97)

·Gender (m:f)

 Intervention: 120/26

 Control: 129:18

·Obesity (BMI>30.0 to ≥37 

kg/m

2

)

 Intervention: 40 (27.6%)

 Control: 20 (13.6%)

 P=0.003

·Comorbidities

Diabetes Mellitus, n (%)

Type I or Type II

 Intervention: 49 (33.6%)

 Control: 49 (33.3%)

Tobacco Use, n (%)

Intervention group:

Intention to treat (ITT): n= 146

Per protocol: n=131 

Surgical sites were prepared with 

commonly used surgical skin 

preparations such as povidoneiodine or 0.7% available iodine in 

isopropyl alcohol 74%w/w.

Skin sealant was applied on the 

surgical sites after surgical skin 

preparations and just before 

making the incision. Surgical incise 

drapes (if used) were applied after 

all surgical skin preparations had 

dried completely. Skin sealant was 

considered dry when a film formed 

on the skin.

Timing of intervention: 

Intraoperatively

Duration of intervention: 

Intraoperatively

Device/agent: Cyanoacrylate-based 

skin sealant

Monitoring intervention: NR

SSI: (follow up 30 days 

postop)

Patients may have more 

than 1 SSI

For ITT Analysis Below 

 Intervention: n=146

 Control: n=147

Total SSIs:

 23/293 (7.8%)

 Intervention: 9/146 

(6.2%)

 Control: 14/147 (9.5%)

 p=0.285

The majority were 

superficial SSIs:

Incision site infection

 Intervention: 6 (2.7%)

 Control: 10 (6.6%)

Although there frequency 

of patients with SSI was 

similar between groups, 

the use of skin sealant 

was associated with a 

Definitions: 

SSI: CDC/ NNIS criteria

Adverse events: any undesirable 

clinical occurrence in a patient 

that may be attributed to the 

study treatment or to SSI.

Perioperative care: NR 

Other notes: None

Follow-up: For the duration of 

hospitalization and for 30 days 

postop
Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminated by the Centers for Disease Control and Prevention 

and should not be construed to represent any agency determination or policy. 219

Author 

Year

(Ref ID_

Extractor)

Study 

Design

Qualit

y 

Score

Study 

Objective Population and Setting Intervention Results Comments

 Intervention: 84 (57.5%)

 Control: 91 (61.9%)

Alcohol use

 Intervention: 42 (28.8%)

 Control: 52 (35.4%)

Duration of surgery (min):

Intervention: 227.6 (42.4)

Control: 211.7 (60.6)

P=0.469

Intraaortic balloon pump:

Intervention: 9 patients

Control: 4 patients

Procedures: Elective 

Coronary artery bypass 

grafting (CABG)

Indications: NR

Setting: 5 Centers

Location: USA, Europe, Asia 

and Latin America

Dates: April 2006 - February 

2009

Inclusion Criteria: Patients 

aged 18 years or older 

who were undergoing 

elective CABG surgery 

with median sternotomy 

and the use of saphenous 

vein or radial artery as 1 

of the graft sites.

Exclusion Criteria: Patients 

undergoing additional 

procedures, known 

sensitivity or allergy to 

cyanoacrylate, isopropyl 

alcohol, iodine or iodineControl group:

ITT: n= 147 

Per Protocol: n=138 

Surgical sites were prepared with 

commonly used surgical skin 

preparations such as povidoneiodine or 0.7% available iodine in 

isopropyl alcohol 74%w/w.

Standard preventive measures:

NR

Non-standard preventive measures:

AMP: administered at the discretion of 

the surgeon and according to 

hospital protocol

Surgical procedure: dictated by current 

practice and not specified in the 

study protocol

35% relative risk 

reduction in the 

occurrence of SSI

 In the subgroup of obese 

patients, there was a 

relative risk reduction 

for SSI of 83.3% 

associated with use of 

skin sealant. However, 

this is based on small 

patient and event 

numbers: 

 Obesity

 Intervention: 1/40 (2.5%)

 Control: 3/20 (15.0%)

 P=0.0.015

Patients with at least one 

SSI:

Sternal Site Infection 

 Intervention: 4 (2.7%)

 Control: 7 (4.8%)

 P=0.363

Graft Site Infection 

 Intervention: 7 (4.8%)

 Control: 7 (4.8%)

 P=0.989

NOTE: 

Left saphenous vein graft 

harvest in 74%-78% of 

patients

Left radial artery or right 

saphenous vein graft 

harvest in 25-30% of 

patients
Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminated by the Centers for Disease Control and Prevention 

and should not be construed to represent any agency determination or policy. 220

Author 

Year

(Ref ID_

Extractor)

Study 

Design

Qualit

y 

Score

Study 

Objective Population and Setting Intervention Results Comments

containing products or 

tape. Also abnormal skin 

conditions around the 

surgical incision site, 

antimicrobialimpregnated incise 

drapes used during the 

operation, chemotherapy, 

immunosuppressive 

therapy or steroid 

therapy, use of 

antimicrobials for an 

active infection, HIV 

infection with CD4 count 

<350mm3, therapeutic 

radiation or renal dialysis, 

morbid obesity 

(BMI>37kg/m2); 

neutropenia, intraaortic 

balloon pump or 

mechanical assist device 

in place preoperatively, 

and hospital stay >14 days

Location and number of 

harvest sites did not 

appear to affect risk of 

SSI “but does add 

further variation to the 

study”

Sternal and/or Graft 

Site(s)_ Infection 

 Intervention: 9 (6.2%)

 Control: 14 (9.5%)

 P=0.285

Both Sternal and Graft Site 

Infection 

 Intervention: 2 (1.4%)

 Control: 0

 P=0.247

Infections for Total 

Population

 Denominators:

 Intervention: n= 146 

 Control: n= 147 

Arteriovenous graft site 

infection

 Intervention: 1 (0.7%)

 Control: 0

Incision site infection

 Intervention: 6 (2.7%)

 Control: 10 (6.6%)

Mediastinitis

 Intervention: 3 (2.1%)

 Control: 2 (1.4%)

Osteomyelitis

 Intervention: 1 (0.7%)
Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminated by the Centers for Disease Control and Prevention 

and should not be construed to represent any agency determination or policy. 221

Author 

Year

(Ref ID_

Extractor)

Study 

Design

Qualit

y 

Score

Study 

Objective Population and Setting Intervention Results Comments

 Control: 1 (0.7%)

Postoperative Wound 

Infection

 Intervention: 0

 Control: 1 (0.7%)

Skin graft Infection

 Intervention: 0

 Control: 1 (0.7%)

Wound Infection

 Intervention: 1 (0.7%)

 Control: 0

Other infections: NR

Topic-specific outcomes:

Frequency of Surgical Site 

infection in patients 

with Alcohol use, 

Tobacco use & Obesity

Alcohol Use

 Intervention: 2/42 (2.7%)

 Control: 6/52 (4.8%)

 P=0.291

Tobacco Use

 Intervention: 3/84 (3.6%)

 Control: 11/91 (12.1%)

 P=0.050

Obesity

 Intervention: 1/40 (2.5%)

 Control: 3/20 (15.0%)

 P=0.0.015

Skin sealant associated 

with a relative risk 

reduction of 83% for 

obese patients

Alcohol Use or Tobacco 
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and should not be construed to represent any agency determination or policy. 222

Author 

Year

(Ref ID_

Extractor)

Study 

Design

Qualit

y 

Score

Study 

Objective Population and Setting Intervention Results Comments

Use or Obesity

Graft Site Infection

 Intervention: 2/108 

(1.9%)

 Control: 6/112 (5.4%)

 P=0.037

Sternal Site Infection 

 Intervention: 4/108 

(4.6%)

 Control: 5/112 (4.5%)

 P=0.546

Graft and/or Sternal Site 

Infection 

 Intervention: 5/108 

(4.6%)

 Control: 11/112 (9.8%)

 P=0.024

Reoperations:

Postoperative reexploration of sternal 

incision site

 Intervention: 5/ 146 

(3.4%)

 Control: 3/ 147 (2.0%)

Length of stay: NR

Mortality: 4 (1.4%) total 

(none considered 

related to study 

treatment)

 Intervention: 1/146 

(0.7%)

 Sudden death after 

spasm of the graft, 

myocardial infarction, 
Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminated by the Centers for Disease Control and Prevention 

and should not be construed to represent any agency determination or policy. 223

Author 

Year

(Ref ID_

Extractor)

Study 

Design

Qualit

y 

Score

Study 

Objective Population and Setting Intervention Results Comments

pulmonary embolism, 

and air embolism

 Control: 3/ 147 (2.0%)

 1/3 excessive bleeding, 

atrial fibrillation, and 

global abdominal 

ischemia

 1/3: ventricular 

fibrillation

 1/3: hemorrhagic shock, 

erosion of the right 

atrium and 

mediastinitis

 P=0.363

Adverse events:

 Intervention: n= 146 

 Control: n= 147 

Overall fewer than 10% of 

subjects experienced 

adverse events during 

the study and most 

were related to SSIs

Erythema

 Intervention: 1/146 (0.7

 Control: 0/ 147 

Surgical and medical 

procedures: 

Hospitalization

 Intervention: 0/ 146 

 Control: 1/ 147 (0.7%)
Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminated by the Centers for Disease Control and Prevention 

and should not be construed to represent any agency determination or policy. 224

Author 

Year

(Ref ID_

Extractor)

Study 

Design

Qualit

y 

Score

Study 

Objective Population and Setting Intervention Results Comments

Iyer

2011 93

(ES)

RCT

1, 3, 4, 

5, 10

To determine 

the effect of 

pretreatment 

with n-butyl 

cyanoacrylate

-based 

microbial skin 

sealant to the 

saphenous 

vein graft 

harvest site 

in a 

population 

undergoing 

cardiac 

surgery and 

discuss its 

potential use 

in decreasing 

infections in 

other kinds of 

surgery.

Number of patients: N=47 

(94 legs) Patients served 

as their own controls

Patient Characteristics: 

Baseline characteristics 

between the treated and 

untreated legs were 

similar because the 

procedure was conducted 

on the same individual.

·Age y, mean (SD): 67.0 (7.6)

·Gender (m:f): 39:8

·Obesity- NR

·Comorbidities

Arterial hypertension: 31 

(65.9%)

Peripheral vascular disease: 

0 (0%)

Venous disease in the legs: 0 

(0%)

Diabetes Mellitus: 12 (25.5%)

Hyperlipidemia: 40 (85.1%)

Renal Failure: 4 (8.5%)

Ejection fraction, mean (SD): 

47.3 (13.3)

Procedures: Coronary artery 

bypass graft (CABG) 

requiring 3 or more 

lengths of long saphenous 

vein to achieve 

revascularization. 

Additional internal 

thoracic conduit was also 

routinely used

Indications: NR

Intervention group: n= 47

The long saphenous vein grafts were 

taken from the below-knee 

segment in both legs of all patients. 

Skin was disinfected using alcoholic 

povidone-iodine solution & 3 

minutes were allowed for the 

disinfecting solution to dry. The 

sealant was applied to only 1 leg 

per case after the disinfecting 

solution was allowed to dry. An 

applicator was used to apply a 

single even layer of microbial 

sealant over an area overlying the 

saphenous vein harvest site. The 

sealant was allowed to dry for 2 

minutes.

Skin sealant was NOT used at the 

sternal site.

Timing of intervention:

Intraoperatively

Duration of intervention: 

Intraoperatively

Device/agent: Cyanoacrylate- based 

skin sealant

Monitoring intervention: NR

Control group: n= 47

Skin was disinfected using alcoholic 

povidone-iodine solution & 3 

minutes were allowed for the 

disinfecting solution to dry. No skin 

sealant.

Standard preventive measures:

Surgical technique: apart from 

application of the sealant, the 

SSI: (follow up: 1 month)

Total saphenous vein 

harvest site SSI: 13/94 

(13.8%)

Intervention: 1/ 47 (2.1%)

Control: 12/ 47 (25.5%)

P=0.0011; 95% CI for 

difference (-0.374 to -

0.0945)

Intervention: The leg 

developed a severe 

infection and required 

incision and drainage. 

In the same patients, 

the untreated leg had 

no infection.

Control: These 12 legs 

showed evidence of 

infection that ranged 

from oozing of serous 

fluid which responded 

to conservative therapy 

(n=7) to severely 

infected wound 

requiring incision and 

drainage (n=4) and 

debridement (n=1)

There were no other 

infections observed at 

30 days and 

investigators were not 

aware of any infections 

developing after this 

Definitions: 

Infection: if the wound showed 

signs of infection, it was 

graded by the Southampton 

wound grading system (Bailey 

1992)

Grades as follows:

0: Normal healing

1: Normal healing with bruising 

or erythema, subclassified as 

A, B, or C according to the size 

of bruising

2: erythema with other signs of 

inflammation subclassified as 

A, B, or C according to findings 

at 1 point around the suture 

or around the whole wound

3: hemoserous discharge (A<2cm, 

B>2cm, C=large volume, d>3 

days)

4: purulent discharge (A<2cm, 

B>2cm)

5: deep or severe infection with 

or without tissue breakdown.

Perioperative care: NR

Other notes: the study was 

terminated after ethical 

committee review at the 

enrollment of 47 patients 

Follow-up: 1 month (if the 

general practitioner involved 

with the care after discharge 

detected an infection before 

the 4-week follow-up, an 

appointment was arranged 
Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminated by the Centers for Disease Control and Prevention 

and should not be construed to represent any agency determination or policy. 225

Author 

Year

(Ref ID_

Extractor)

Study 

Design

Qualit

y 

Score

Study 

Objective Population and Setting Intervention Results Comments

Setting: 1 hospital

Location: Australia

Dates: Began August 2008 -

???? (NR)

Inclusion Criteria: Patients 

undergoing CABG 

requiring 3 or more 

lengths of long saphenous 

vein to achieve 

revascularization

Exclusion Criteria: If the 

patient required ≤2 

segments of vein wherein 

only 1 leg was used and 

any features that would 

cause dissimilarity 

between the legs, which 

included the vein in either 

leg not being usable, 

unilateral vascular 

disease, or skin lesion. 

Also if there was a 

discrepancy in the length 

of the incision between 

the treated and untreated 

legs.

surgical technique in both legs was 

identical and the vein was 

harvested using a single open 

incision. Endoscopic techniques 

were not employed and in most of 

the patients, the below portion of 

the vein was harvested. 

Hair removal: performed using an 

electrical clipper the day before 

surgery. 

Shower: patients washed with soap the 

morning of surgery

Drapes: iodine impregnated drapes 

were used in all patients.

Closure: Closure of the subcutaneous 

layer was with 2-0 absorbable, 

braided synthetic sutures, and 

subcuticular closure of the skin was 

with 3-0 synthetic absorbable 

sutures. A hydrocolloid dressing 

was used in all patients

Normothermia: All patients underwent 

systemic cooling to 32oto 34oC.

point.

Other infections: NR

Topic-specific outcomes: 

Southampton Grade

Intervention: 1/1: Grade 

4B

Control: 3/12: Grade 5

 2/12: Grade 4B

 2/12: Grade 3D

 4/12: Grade 3B

 1/12: Grade 3A

Reoperations: 

Intervention: The infected 

leg required incision 

and drainage.

Control: 1 severely 

infected leg required 

debridement.

Length of stay: NR

Mortality: NR

Adverse events:

No patients had 

perioperative 

infarctions and there 

were no adverse 

intraoperative events.

before the stipulated followup and the findings were 

recorded.

Towfigh

2008 94

(ES)

RCT

1, 2, 3, 

4, 5, 7, 

8, 9, 

10

To compare 

the safety 

and 

effectiveness 

of microbial 

sealant in 

reducing the 

Number of patients: N=166 

(evaluable for 

effectiveness of 

antimicrobial sealant)

Note: 148 (84%) in per 

protocol analysis 

Patient Characteristics: 

Intervention group: n=83 

(Per Protocol: 68)

Standard surgical skin preparation 

including a skin prep of 10% 

povidone-iodine on the operative 

field which was allowed to dry. This 

was followed by a single coat 

SSI (2 and 4 weeks):

Total SSI: 3/148 (2%)

Intervention: 0

Control: 3/80 (3.8%)

 All 3 SSIs were positive 

for S. aureus and 1/3 of 

these was a deep 

Definitions: 

Signs of infection: swelling, 

erythema, drainage, warmth. 

And dehiscence.

Perioperative care: NR 

Other notes: A patient was 

considered lost to follow up 
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and should not be construed to represent any agency determination or policy. 226

Author 

Year

(Ref ID_

Extractor)

Study 

Design

Qualit

y 

Score

Study 

Objective Population and Setting Intervention Results Comments

incidence of 

surgical 

incision 

bacterial 

contaminatio

n relative to 

surgical skin 

preparation 

alone in 

elective open 

inguinal 

hernia repair.

There were no statistically 

significant differences 

between the two groups.

·Age: mean (SD) y

 Intervention: 52.7 (15.9)

 Control: 54.1 (14.9)

Values below based on

 Total pop: N=177

 Intervention n=88 

 Control n=89

·Gender (male)

 Intervention: 84/88 (95.5%)

 Control: 86/89 (96.6%)

·Obesity: (BMI>30kg/m2)

 Intervention: 27 (30.7%)

 Control: 18 (20.2%)

·Comorbidities

Diabetes Mellitus

 Intervention: 2 (2.3%)

 Control: 4 (4.5%)

7 patients had comorbid 

clinical characteristics 

that have been reported 

to be associated with 

wound complications 

such as hyperhidrosis, 

eczema, psoriasis, or an 

autoimmune disease. 

One patient had a 

previous history of SSI.

Procedure duration: (min)

Mean (SD)

 Intervention: 73.7 (28.4)

 Control: 75.6 (31.5)

Procedures: Open inguinal 

application of the cyanoacrylatebased microbial sealant. The 

sealant was allowed to dry before 

the application of surgical drapes.

Timing of intervention: Pre intra, and 

postoperatively

Duration of intervention: Pre intra, 

and postoperatively

Device/agent: Cyanoacrylate-based 

microbial sealant

Monitoring intervention: NR

Control group: n=83

(Per Protocol: 80)

Standard surgical skin preparation 

including a skin prep of 10% 

povidone-iodine on the operative 

field which was allowed to dry.

Standard preventive measures:

Instruction: all principal investigators 

were given hands-on instruction in 

how to use the applicator prior to 

enrollment of subjects.

Non-standard preventive measures: 

Surgeons were allowed to perform the 

open inguinal hernia repair based 

on their personal preference with 

respect to hair clipping, 

perioperative antimicrobials, 

surgical techniques and use of mesh

Preoperative data:

Based on Total population N=176 

because data missing from 1 

intervention

Antimicrobial shower:

infection with MRSA

Given the low number of 

events and early 

termination of the 

study, it is 

underpowered to 

detect a difference in 

SSI.

Other infections: NR

Topic-specific outcomes:

Most patients did not 

maintain a sterile 

wound throughout 

surgery regardless of 

resultant SSI or not.

 One surgeon reported 

visible flaking of the 

microbial sealant film 

during the procedure.

One patient in the 

microbial sealant group 

had skin irritation 

(resolved on its own)

 Surgeons reported 4 

incidents of difficulty 

incising through the 

clear film.

Reoperations:

The deep MRSA infection 

from the control group 

required readmission, 

debridement, mesh 

removal and 

intravenous 

after 4 unreturned attempts 

at contact.

Follow-up: at 2 and 4 weeks 

postoperatively to access the 

incision
Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminated by the Centers for Disease Control and Prevention 

and should not be construed to represent any agency determination or policy. 227

Author 

Year

(Ref ID_

Extractor)

Study 

Design

Qualit

y 

Score

Study 

Objective Population and Setting Intervention Results Comments

hernia repair.

Indications: NR

Setting: 6 Teaching hospitals

Location: USA

Dates: July 2005 - September 

2006 (Clinical trial 

discontinued in 

September of 2006 when 

FDA granted regulatory 

approval for this product 

as a class II medical 

device.

Inclusion Criteria: Scheduled 

for open, class 1 clean 

inguinal hernia repair; 

aged 18 or older; able to 

complete mean (SD) 30 

(5) day follow-up.; and 

able and willing to 

provide informed consent

Exclusion Criteria: Known 

sensitivity to 

cyanoacrylate 

formaldehyde or acetone 

products or iodine or 

iodine containing 

products; surgical 

procedures involving 

mucous membranes or 

eyes; laparoscopic 

surgical procedures; 

evidence of coexistent 

infection at a remote 

body site; skin rashes or 

exfoliative condition the 

 Intervention: 23/87 (26.4%)

 Control: 24/89 (27.0%)

Hair removal: 173/176 (98.3%) 

 Clipping/shaving

 Intervention: 45/35

 Control:47/36

AMP: administered to 131/176 (74%)

 Intervention: 61/87 (70.1%)

 Control: 70 (78.7%)

Mesh implanted

 Intervention: 71/88 (81.6%)

 Control: 72/89 (80.9%)

Closure using sutures

 Intervention: 87/88 (98.9%)

 Control: 88/89 (98.9%)

Wound covered with a dressing

 Intervention 77 (87.5%)

 Control: 80 (89.9%)

 P=0.62

antimicrobials.

Length of stay: NR

Mortality: NR

Adverse events:

Serious adverse events

All serious adverse events 

occurred in the control 

group and resolved at 

final follow up

Admission for SSI due to 

MRSA:1

 Groin hematoma: 1

 Chest pain: 1

 Dyspnea: 1

Scrotal edema: 1

Knee pain: 1

Non-serious adverse 

events

Scrotal edema, hematoma

 Intervention: 3

 Control: 2

Wound dehiscence

 Intervention: 1

 Control: 0

Incisional pain/ swelling

 Intervention: 1

 Control: 1

Skin irritation

 Intervention: 1

 Control: 0

 Possibly attributable to 

investigational device

Constipation

 Intervention: 1

 Control: 0
Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminated by the Centers for Disease Control and Prevention 

and should not be construed to represent any agency determination or policy. 228

Author 

Year

(Ref ID_

Extractor)

Study 

Design

Qualit

y 

Score

Study 

Objective Population and Setting Intervention Results Comments

day of surgery; history of 

keloid formation; 

currently receiving highdose steroid or 

immunosuppressive 

therapy; chemotherapy 

treatment within 30 days 

of current surgery; 

diagnoses of diabetes 

HbA>7.0% obtained 

within 90 days; use of 

oral, IV or topical (in 

expected area of incision) 

antimicrobials within 20 

days prior to the day of 

surgery; pregnant or 

nursing; or participation 

in any other study of an 

investigational drug or 

device within 2 week 

prior to the current 

procedure.

Incisional bleeding

 Intervention: 1

 Control: 0

Urinary frequency

 Intervention: 0

 Control: 1

Urinary retention

 Intervention: 1

 Control: 1

Epigastric hernia drainage

 Intervention: 1

 Control: 0

Decreased limb sensation

 Intervention: 0

 Control: 1

D. How safe and effective are plastic adhesive drapes?

Author 

Year

(Ref ID_ 

Extractor)

Study 

Design

Qualit

y 

Score

Study 

Objective Population and Setting Intervention Results Comments
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and should not be construed to represent any agency determination or policy. 229

Author 

Year

(Ref ID_ 

Extractor)

Study 

Design

Qualit

y 

Score

Study 

Objective Population and Setting Intervention Results Comments

Ward

2001 95

(ES)

RCT

1, 2, 3, 

4, 5, 6, 

7, 8, 9

To evaluate 

the ability of 

the new 

generation of 

adhesive 

surgical 

drapes to 

prevent Post 

Cesarean 

Wound 

Infection.

Number of patients: N=605

Patient Characteristics: 

Characteristics were 

similar between groups.

Procedures: Caesarean 

Section

Setting: 1 Regional referral 

hospital

Location: South Africa

Dates: Aug 18, 1992 –

January 29, 1993

Inclusion Criteria: 

Consecutive patients 

undergoing Caesarean 

Section

Exclusion Criteria: Women 

having coincidental 

appendix ruptured or 

requesting early 

discharge.

Intervention group: n=305

After drying the cleansed area, a 

plastic adhesive drape was carefully 

applied to the skin and toweling 

and this remained in situ until the 

last skin suture or staple had been 

inserted. The drape was then 

removed and a dressing applied. 

Timing of intervention: 

Intraoperatively

Duration of intervention: 

Intraoperatively

Device/agent: plastic adhesive drape

Control group: n=298

Same standard preventive measures 

but no drape was applied.

Standard preventive measures:

Skin Prep: preoperatively, abdomen 

and perineum were washed with 

4% chlorhexidine soap. On the 

Operating table, the abdomen was 

liberally swabbed with a solution of 

0.5% chlorhexidine in 80% alcohol 

for at least 30s over an area 

extending from the xiphosternum 

to the flanks, down as far as the 

mid-thigh and across to the 

perineum in the midline. The 

surgeon then scalpel shaved an area 

2cm either side of the proposed 

incision site. Standard sterile double 

towel draping followed. The site 

was padded dry with a sterile swab 

AMP: At clamping of umbilical cord, 

patient received 1g of cephazolin 

SSI: 

Drape: 34/305 (11.1%)

No Drape: 30/298 (10.1%)

P=0.6933

Definitions: 

Infection: if two of the 3 

following features were 

present:

1) Erythematous cellulitis 

(erythematous induration 

either side of the incision 

line

2) Seropurulent discharge 

from the wound.

3) Positive swab culture 

(organisms and leucocytes).

Perioperative care: NR 

Other notes: None

Follow-up: 5 days.
Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminated by the Centers for Disease Control and Prevention 

and should not be construed to represent any agency determination or policy. 230

Author 

Year

(Ref ID_ 

Extractor)

Study 

Design

Qualit

y 

Score

Study 

Objective Population and Setting Intervention Results Comments

intravenously unless antimicrobials

were already being administered as 

therapy or prophylaxis. A 1g 

metronidazole suppository was 

inserted preoperatively and 

repeated after 12h.

Chiu

1993 96

(ES)

RCT

1 

To 

investigate 

the 

effectiveness

of plastic 

adhesive skin 

drapes in the 

prevention of 

wound 

infection 

after acute 

hip fracture 

operations.

Number of patients: N= 120

Patient Characteristics: The 

two groups were matched 

for patient characteristics.

Procedures: Acute Hip 

Fracture including

Internal fixation with 

sliding hip-screw done for 

trochanteric fractures; 

Austin-Moore femoral 

head replacement 

inserted for displaced 

subcapital fracture in 

older patients; and for 

undisplaced fractures or 

for displaced fractures in 

young patients, the 

fracture was fixed with 

three cancellous lag 

screws.

Setting: 1 University Hospital

Location: China

Dates: January – December 

1991

Inclusion Criteria: patients 

with hip fracture 

operations done by one 

Intervention group: n= 65

Operation site was covered with a 

plastic adhesive drape.

Timing of intervention: 

Intraoperatively+

Duration of intervention: 

Intraoperatively

Device/agent: plastic adhesive drape

Control group: n= 55

Operation site was left uncovered.

Same standard preventive measures 

but no drape was applied.

Standard preventive measures:

Ultraclean air: there was no laminar 

flow, ultraclean air, or exhaust suits 

in the operating room.

AMP: cephalosporin antibiotic was 

given at induction of anesthesia. 

Skin prep: Operation site was prepared 

with povidone solution then wiped, 

dried and draped with sterile 

towels.

SSI: 

Total: 11/120 (9.2%)

 Drape: 6/65 (9.2%)

 Superficial: 5/65 (7.7%)

 Deep: 1/65 (1.5%)

 No Drape: 5/55 (9.1%)

 Superficial: 4/55 (7.3%)

 Deep: 1/55 (1.8%)

Definitions: NR

Perioperative care: NR 

Other notes: None

Follow-up: NR
Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminated by the Centers for Disease Control and Prevention 

and should not be construed to represent any agency determination or policy. 231

Author 

Year

(Ref ID_ 

Extractor)

Study 

Design

Qualit

y 

Score

Study 

Objective Population and Setting Intervention Results Comments

of two surgeons done in 

the same operating 

theater.

Exclusion Criteria: NR

Q9. How safe and effective is antiseptic irrigation prior to closing the surgical incision?

Author

Year

(Data 

Extractor)

Risk of 

Bias 

Score

Study Objective Population and Setting Intervention Results Comments

Chang

2006 100

(ES)

RCT

1, 2, 4, 

6, 7, 8, 

9, 10 

To evaluate the 

effect of wound 

irrigation with 

povidoneiodine on 

wound healing, 

infection rate, 

fusion status 

and clinical 

outcome of 

spinal surgeries

Number of patients: 

n=244

Patient Characteristics: 

patient characteristics 

were not statistically 

significantly different 

between groups.

Procedures: primary 

instrumented 

lumbosacral 

posterolateral fusion 

levels for degenerative 

spinal disorder.

Indications: lumbar or 

lumbosacral segmental 

instability defined by 

chronic back, buttock 

and/or leg pain and 

degenerative 

spondylolisthesis, 

Intervention group: n=120

Wounds were irrigated with 

0.35%povidone-iodine solution to 

soak for 3min, followed by 

irrigation with 2000cc of normal 

saline to remove povidone-iodine 

solution. 

Timing of intervention: 

intraoperative

Duration of intervention: 3min

Device/agent: 0.53% povidoneiodine solution

Monitoring intervention: NA

Control group: n=124

Wound was only irrigated with

2000cc normal saline

Standard preventive measures: 

Pain control – 3 days postop. 

AMP: preop IV bolus injections of 

cefazolin and gentamicin, 

SSI: 

Superficial: no infections in 

either group

Deep: 

 Intervention: 0/120

 Control: 6/124 (4.8%)

 P=0.29

Other infections: NR

Topic-specific outcomes: 

NR

Reoperations: NR

Length of stay: NR

Mortality: NR

Adverse events: one 

incidence of wound 

dehiscence event with 

0.35% povidone iodine 

followed by normal 

saline irrigation.

Definitions:

Superficial infection: above 

lumbosacral fascia

Deep infections: below 

lumbosacral fascia & all deep 

infections were confirmed by 

lab parameters including the 

erythrocyte sedimentation 

rate (ESR) and level of Creactive protein (CRP) and a 

positive culture of biopsy.

Perioperative care: NA 

Other notes: none

Follow-up: every three months 

until the end of the study. 

Duration was approx. 

19months.
Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminated by the Centers for Disease Control and Prevention 

and should not be construed to represent any agency determination or policy. 232

Author

Year

(Data 

Extractor)

Risk of 

Bias 

Score

Study Objective Population and Setting Intervention Results Comments

degenerative scoliosis, 

or isthmic 

spondylolisthesis.

Setting: 1 university 

hospital

Location: Taiwan

Dates: Jan 2002 – Aug 

2003

Inclusion Criteria: patients 

undergoing primary 

instrumented 

lumbosacral 

posterolateral fusion 

levels for degenerative 

spinal disorder.

Exclusion Criteria: prior 

spinal surgery, spinal 

trauma, malignancy

additional postop cefazolin and 

gentamicin injections were given 

for 48h postop followed by oral 

cefazolin for 3 days postop.

Custom made orthosis immobilized 

patient whenever out of bed for 3 

months postop.

Cheng

2005 101

(ES)

RCT

1, 2, 5, 

7, 8, 9 

10 

To evaluate the 

efficacy of 

dilute betadine 

solution in the 

prevention of 

infection, 

particularly 

deep infection 

following spinal 

surgery

Number of patients: 

N=417

Patient Characteristics: 

there were no 

statistically significant 

differences between 

groups except with age:

·Age (mean) y

 Intervention: 64

 Control: 61

 P=0.0682

Procedures: spinal surgery 

(decompression, 

pedicle screw fixation, 

discectomy, tumor 

excision)

Setting: 1 university 

hospital 

Intervention group: n=208

Wound was soaked with povidone 

iodine solution for 3min (5mL of 

povidone-iodine diluted with 

normal saline to achieve 0.35% 

povidone iodine solution.) The 

wound was then irrigated with 

copious amounts of normal saline 

(2000ml)

Timing of intervention: 

intraoperative

Duration of intervention: 3min soak

Device/agent: -.35% povidone-iodine 

solution

Monitoring intervention

Control group: n=206

Patients 

Standard preventive measures: 

SSI: 

Overall

 Intervention: 0/208

 Control: 7/206 (3.4%)

 P=0.0072

Superficial: 

 Intervention: 0/208

 Control: 1/206 (0.5%)

 P=0.4976

Deep:

 Intervention: 0/208

 Control: 6/206 (2.9%)

 P=0.0146

Other infections: NR

Topic-specific outcomes: 

NR

Definitions:

Infection: suspected when 

unusual pain, tenderness, 

erythema, induration, fever, 

or wound drainage was noted. 

Findings were investigated 

with measurement of ESR, 

CRP, and bacteriological 

cultures from the operative 

site or blood. All patients with 

highly suspected wound 

infection underwent surgical 

debridement.

Follow-up: at 3 month intervals 

until study was over. (mean 

length 15.5 months)
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and should not be construed to represent any agency determination or policy. 233

Author

Year

(Data 

Extractor)

Risk of 

Bias 

Score

Study Objective Population and Setting Intervention Results Comments

Location: Taiwan

Dates: January 2002 – May 

2003

Inclusion Criteria: patients 

undergoing spinal 

surgery.

Exclusion Criteria: 

Mortality in follow-up 

period, also, patients 

with overt or suspected 

pyogenic vertebral 

osteomyelitis, discitis, 

or any form of 

preoperative spinal 

infection; and patients 

with fever or other 

suspected sources of 

infection.

Basic aseptic technique was followed.

Skin prep: with povidone iodine.

AMP: 1 does parenteral cefazolin and 

gentamicin 1h preop then 

Cefazolin every 6h & gentamicin 

every 12 hours for 48h postop. 

Oral antimicrobial doses (cefazolin) 

were continued for 3 days.

Adverse events: no 

product-related 

adverse event with 

0.35% povidone iodine 

followed by normal 

saline irrigation

Sindelar

1985 106

(ES)

RCT

1, 2, 7, 

8, 9

To evaluate the 

efficacy and 

toxicity of 

intraperitoneal 

irrigation with 

Low Molecular 

Weight 

Povidone 

Iodine Solution 

(PVP-I LMW) in 

surgical 

procedures 

performed in 

the face of 

bacterial 

contamination 

(i.e. intraabdominal 

Number of patients: N=75

Patient Characteristics: 

The experimental and 

control groups did not 

statistically differ with 

respect to patient 

characteristics.

Procedures: Contaminated

or dirty Intra-abdominal 

surgical procedures (

Setting: National Institute 

of Health

Location: USA

Dates: NR

Inclusion Criteria: Patients 

18yo or older, 

scheduled for elective 

or emergency intraIntervention group: n=37

Irrigation of the intraperitoneal area 

was performed 3 times during the 

operation with 1000ml of a 10% 

solution of PVP-I LMW. The 

Solution was suctioned from the 

peritoneal cavity 30-60s after 

installation. In patients undergoing 

primary wound closure, irrigation 

of the subcutaneous tissue was 

performed prior to skin closure 

with 1000ml of PVP-I LMW 10%.

Timing of intervention: 

intraoperative

Duration of intervention: duration of 

lavage.

Device/agent: low molecular weight 

povidone iodine solution (10%)

SSI: 

Total Infections

PVP-I LMW: 2/37 (5.4%) 

[dirty]

Saline: 9/38 (26.7%) [7/9 

contaminated; 2/9 

dirty]

Organ/Space Infection

PVP-I LMW: 1/37 (2.7%) 

[dirty]

Saline: 6/38 (15.8%) [4/6 

contaminated; 2/6 dirty

Deep wound infection

PVP-I LMW: 0/37 

Saline: 1/38 (2.6%) [Dirty]

Definitions: NR

Other notes: None

Follow-up: 7days
Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminated by the Centers for Disease Control and Prevention 

and should not be construed to represent any agency determination or policy. 234

Author

Year

(Data 

Extractor)

Risk of 

Bias 

Score

Study Objective Population and Setting Intervention Results Comments

surgical 

procedures 

where there 

was likely to be 

bacterial 

contamination 

of the 

peritoneal 

cavity)

abdominal surgery 

involving entry into the 

peritoneal cavity where 

the surgery was 

classified as 

contaminated or dirty 

(esophageal, gastric, 

small intestinal, colonic, 

hepatic, pancreaticobiliary.

Exclusion Criteria: Patients 

undergoing clean 

operative procedures. If 

there was a history of 

iodine sensitivity, 

thyroid disease, renal 

insufficiency or surgery 

involving ischemic or 

necrotic tissues which 

might interfere with 

wound healing either in 

the presence or 

absence of infectious 

complications.

Control group: n=38

Irrigation of the intraperitoneal area 

was performed 3 times during the 

operation with 1000ml of saline. 

The Solution was suctioned from 

the peritoneal cavity 30-60s after 

installation. In patients undergoing 

primary wound closure, irrigation 

of the subcutaneous tissue was 

performed prior to skin closure 

with 1000ml of saline.

Standard preventive measures: 

AMP: patients received peri-operative 

antimicrobials in accordance to the 

practice of the surgeon 

responsible. 

Superficial wound 

infection:

PVP-I LMW: 1/37 (2.7%) 

[dirty]

Saline: 2/38 (5.3%) [both 

contaminated]

CLEAN (No AMP) 

0/113 vs.7/121 (6%); 

p<0.01 

Potentially Contaminated 

(AMP) 

1/49 vs. 7/49; p<0.05 

Contaminated (AMP) 

3/44 vs. 12 /46; p<0.05 

Dirty (AMP) 

3/36 vs. 13/42; p<0.001

Adverse events: 

Significant increase in 

postop serum Iodine 

levels at 24h resolved 

by 72h. No clinical 

signs of iodine toxicity
Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminated by the Centers for Disease Control and Prevention 

and should not be construed to represent any agency determination or policy. 235

Author

Year

(Data 

Extractor)

Risk of 

Bias 

Score

Study Objective Population and Setting Intervention Results Comments

Vallance

1985 105

(ES)

RCT

1, 7, 8, 

9

To compare a 

PovidoneIodine solution 

against saline 

alone for 

peritoneal 

lavage in 

patients 

undergoing 

operations for 

generalized 

purulent or 

fecal peritonitis

Number of patients: N=29

Patient Characteristics: 

Patient characteristics 

were not statistically 

different between the 

groups.

Procedures: dirty 

laparotomy procedures

Setting: 1 hospital

Location: UK

Dates: NR

Inclusion Criteria: Patients 

who were confirmed at 

laparotomy to have 

generalized purulent or 

fecal peritonitis.

Exclusion Criteria: Patients 

dying within 4 days of 

the operation.

Intervention group:

PVP-I: n=13

Patients who received a saline lavage 

until solutions returned clear with 

100ml PVP-I solution inserted 

before wound closure 

Timing of intervention: 

intraoperatively

Duration of intervention: NR

Device/agent: PVP-I or saline

Control group: 

Saline: n=16

Patients who received a saline lavage 

until solutions returned clear with 

inserted before wound closure 

Standard preventive measures 

Fluid maintenance: all patients were 

resuscitated with iv fluids before 

surgery

AMP: all patients were begun on 

broad spectrum antimicrobial 

postop prophylaxis which were 

continued for at least 5 days 

postop. 

SSI: 

PI: 4/13 (31%) 

Saline: 5/16(31%)

p=NS

Definitions: NR

Other notes: None

Follow-up: 30 days

Rogers

1983 103

(ES)

RCT

1, 2, 7, 

8, 9

To elucidate 

further the 

potential value 

of Povidone 

Iodine wound 

irrigation as an 

adjunct in the 

prevention 

postoperatively 

of wound 

infections.

Number of patients: 

N=187

Patient Characteristics: 

Procedures: Clean 

(Inguinal hernia repair, 

cholecystectomy, 

laparotomy, hiatal 

hernia repair, proximal 

gastric vagotomy, 

ventral hernia, and 

other), clean 

contaminated (upper 

Intervention group: n=86

After fascial closure, patients 

underwent an approximate one 

minute irrigation of the subcutaneous 

tissue with approximately 60ml of 

10% Povidone Iodine (1% available 

iodine) solution.

Timing of intervention: 

intraoperative

Duration of intervention: approx. 1 

minute

Device/agent: PVP-I or saline

SSI: 

Clean (No AMP) 

P-I: 2/56 (3.6%) 

Saline: 6/68 (8.8%) 

p=?? 

Clean-contaminated (AMP) 

P-I: 1/24 (4.2%)

Saline: 5/27 (18.5%)

p=?

Dirty (AMP) 

Definitions: 

Wound infection: any wound in 

which a purulent discharge 

occurred during a month of 

observation after the 

operation.

Other notes: None

Follow-up: 1 month
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and should not be construed to represent any agency determination or policy. 236

Author

Year

(Data 

Extractor)

Risk of 

Bias 

Score

Study Objective Population and Setting Intervention Results Comments

gastrointestinal, 

colorectal, biliary tract, 

appendectomy and 

other clean 

contaminated 

surgeries), and Dirty 

(perforated viscus, 

traumatic perforation 

procedures) 

procedures.

Setting: 1 veterans 

hospital

Location: USA

Dates: July 1, - December 

31, 1979

Inclusion Criteria: All 

patients undergoing 

operative procedures

Exclusion Criteria: 

operations on the 

anorectal area; also 

patients who died or 

who required 

reoperation within 

three weeks of primary 

operation unless the 

wounds were obviously 

infected. Vascular 

procedures and 

operations on the head 

and neck

Control group: n=101

After fascial closure, patients 

underwent an approximate one 

minute irrigation of the subcutaneous 

tissue with saline solution.

Standard preventive measure:

AMP: administered to all patients 

perioperatively in both the cleancontaminated and dirty categories.

Bowel Prep: mechanical (cleansing 

enema, cathartics & low residue 

liquids) and antimicrobial bowel 

prep (orally administered 

neomycin and erythromycin base) 

were used for elective colorectal 

surgeries.

P-I: 1/6 (16.6%)

Saline: 1/6 (16.6%)

p=NS 
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and should not be construed to represent any agency determination or policy. 237

Author

Year

(Data 

Extractor)

Risk of 

Bias 

Score

Study Objective Population and Setting Intervention Results Comments

Sindelar

1979 102

(ES)

RCT

1, 7, 8, 

9

To evaluate the 

efficacy of 

povidoneiodine 

irrigations of 

subcutaneous 

tissue during 

wound closure 

in reducing the 

incidence of 

superficial 

wound 

infections for a 

variety of 

surgical 

incisions.

Number of patients: 

N=266

Patient Characteristics: 

patient groups were 

similar in age, sex 

distribution and types 

of surgery.

Procedures: both elective 

and emergency surgical 

procedures including 

abdominal & 

gastrointestinal 

procedures, oncologic 

procedures, vascular 

reconstructions, head 

and neck operations, 

thoracic and 

genitourinary 

procedures and trauma 

operations.

Setting: 1 university 

hospital

Location: USA

Dates: NR

Inclusion Criteria: patients 

undergoing operative 

procedures.

Exclusion Criteria: 

Amputations for 

ischemic disease, 

drainage of 

subcutaneous 

abscesses, skin grafting 

and anorectal 

procedures. Also, 

patients with a history 

Intervention group: n=129

Patients had subcutaneous tissues 

irrigated for 60 seconds with 10% 

povidone-iodine solution

Timing of intervention: 

intraoperative

Duration of intervention: 60 seconds

Device/agent: 1% available iodine, 

povidone-iodine solution

Control group: n=137

Patients had subcutaneous tissues 

irrigated for 60 seconds with saline 

solution

Standard preventive measures 

AMP: Parenteral AMP preop and for 

48h postop

SSI: 

Superficial SSI:

PI: 7/129

Saline: 32/137

Potentially Contaminated

PI: 1/49 

Saline: 7/49

p<0.05 

Contaminated

PI: 3/44 

Saline: 12 /46

p<0.05 

Dirty 

PI: 3/36 

Saline: 13/42

p<0.001

Adverse events: no 

significant change in 

free iodine serum 

levels

Definitions: 

Infection: if any amount of pus 

was discharged within 12 

weeks of operation. Serous 

drainage from questionable 

wounds was cultured and was 

considered infected if any 

bacterial growth was 

recovered.

Follow-up: up to 12 weeks 

postop.
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and should not be construed to represent any agency determination or policy. 238

Author

Year

(Data 

Extractor)

Risk of 

Bias 

Score

Study Objective Population and Setting Intervention Results Comments

of iodine sensitivity, 

thyroid diseases and 

significant renal 

impairment

Sindelar

1979 104

(ES)

RCT

1, 5, 7, 

8, 9

To study both 

the possible 

toxicity and the 

possible benefit 

of povidoneiodine 

peritoneal 

irrigations in 

reducing the 

incidence of 

intra-abdominal 

abscess 

formation in 

patients with 

contaminated 

abdomens.

Number of patients: 

N=168

Patient Characteristics: 

patient groups were 

similar in age, sex 

distribution and types 

of surgery.

Procedures: Laparotomy: 

surgical explorations in 

the presence of 

bacterially 

contaminated 

peritoneal cavities.

Indications: contaminated 

abdomen

Setting: 1 university 

hospital

Location: USA

Dates: NR

Inclusion Criteria: patients 

undergoing 

laparotomy.

Exclusion Criteria: patients 

with a history of iodine 

sensitivity, thyroid 

disease, or significant 

renal disease.

Intervention group: n=80

Prior to closure, the peritoneal cavity 

was irrigated for 60 seconds with 

1L of 1% povidone-iodine solution, 

giving 0.1% available iodine in 

diluted form. Following irrigation, 

the peritoneum was suctioned and 

the majority (estimated>90%) of 

the irrigant was removed.

Timing of intervention: 

intraoperative

Duration of intervention: 60 seconds

Device/agent: 1% povidone-iodine 

solution

Monitoring intervention: NA

Control group: n=88

Peritoneal cavity was irrigated for 60 

seconds with 1L of normal saline 

solution followed by suctioning.

Standard preventive measures 

Amp: all patients received 

preoperative systemic 

antimicrobial prophylaxis which 

were continued for 48h postop or 

longer if clinically indicated by 

manifestations of sepsis. (typically 

clindamycin and gentamicin except 

in allergy or possible renal 

impairment for which doxycycline 

was substituted).

SSI: 

Intraabdominal Abscess

Overall: 10/168 (5.95%)

 Intervention: 1/80 (1.3%)

 Control: 9/88 (10.2%)

 P<0.05

Dirty Procedures:

 Intervention: 0/36 

 Control: 6/42 (14.3%)

 P<0.05

Contaminated Procedures:

 Intervention: 1/44 (2.3%)

 Control: 3/46 (6.5%)

 P=NS

Other infections: NR

Topic-specific outcomes: 

NR

Reoperations: NR

Length of stay: NR

Mortality: NR

Adverse events: 

Iodine toxicity: 

 Intervention: 5/80 

(6.25%)

 Control: 0/88

Serum iodine levels were 

elevated 24 hours after 

Definitions: 

Intraabdominal abscess: fever, 

persistent pain, palpable 

mass, abnormal 

roentgenograpms, or positive 

ultrasonographic findings. 

Patients with suspected 

abscesses underwent surgical 

exploration.

Adverse event: iodine toxicity

Perioperative care: NR 

Other notes: None

Follow-up: 3 months or until 

death.
Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminated by the Centers for Disease Control and Prevention 

and should not be construed to represent any agency determination or policy. 239

Author

Year

(Data 

Extractor)

Risk of 

Bias 

Score

Study Objective Population and Setting Intervention Results Comments

intraperitoneal 

irrigation with PI 

solution and returned 

to near normal by 73h 

postop and no 

complications from the 

use of PI

Q10. How safe and effective is repeat application of an antiseptic skin preparation agent to the surgical site immediately prior to 

closing the surgical incision?

Author

Year

(Data 

Extractor)

Risk of 

Bias 

Score

Study Objective Population and Setting Intervention Results Comments

Harihara

2006 107

(ES)

RCT

1, 

To investigate 

whether 

incisional 

topical 

application of 

Povidoneiodine (PVP-I) 

just before skin 

closure can 

prevent wound 

infection or SSI. 

Number of patients: 

N=107

(47 Gastric & 60 

colorectal)

Patient Characteristics: 

No significant 

difference was 

observed between 

groups.

·Age: 

Gastric

 Intervention: 

62.1±11.9y

 Control: 65.0±11.9

Colorectal

 Intervention: 62.8±12.3

 Control: 66.3±11.5

·Gender: m:f

Intervention group: n=54 (23 gastric 

and 31 colorectal)

Before skin closure, skin was irrigated 

with 500ml saline solution. 

Povidone-Iodine was applied to 

the skin around the incision twice 

using swabs in the same manner 

as the preoperative skin 

preparation after irrigation and 

just before skin closure. 

Timing of intervention:

Intraoperatively

Duration of intervention: 

Intraoperatively

Device/agent: Povidone-iodine (PVPI)

Monitoring intervention: NR

Control group: n= 52 (23 gastric and 

SSI: (Follow up NR)

Gastric Surgery

Wound Infection: 

 Intervention: 1/23 (4.3%)

 Control: 0/24 

 P=0.4894

SSI

 Intervention: 3/23 

(13.0%)

 Control: 3/24 (12.5%)

 P=0.6460

Colorectal Surgery

Wound Infection: 

 Intervention: 4/31 

(12.9%)

 Control: 4/29 (13.7%)

 P=0.4894

SSI

Definitions: 

SSI: JNIS system which is a 

Japanese modification of the 

CDC NNIS System. 

Wound infection: infection 

excluding organ/space 

infection from SSI.

Perioperative care: NR

Other notes: NR

Follow-up: NR
Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminated by the Centers for Disease Control and Prevention 

and should not be construed to represent any agency determination or policy. 240

Author

Year

(Data 

Extractor)

Risk of 

Bias 

Score

Study Objective Population and Setting Intervention Results Comments

Gastric

 Intervention: 18:5

 Control: 20:4

Colorectal

 Intervention: 18:13

 Control: 15:14

·ASA Physical Status 

(1:2:3:4:5)

Gastric

 Intervention: 

13:10:0:0:0

 Control: 12:12:0:0:0

Colorectal

 Intervention: 

19:10:2:0:0

 Control: 10:17:2:0:0

·Obesity: BMI (only for 

colorectal)

Colorectal

 Intervention: 23.1±3.4

 Control: 21.8±3.2

·Comorbidities: (only for 

colorectal)

Colorectal

Diabetes mellitus (DM)

 Intervention: 3/31 

(9.7%)

 Control: 5/29 (17.2%)

Smoking >30 years

 Intervention: 7/31 

(22.6%)

 Control: 9/29 (31.0%)

Procedures: Gastric and 

colorectal surgery.

Indications: : NR

29 colorectal)

Povidone-Iodine was not applied to 

the skin around the incision just 

before skin closure.

Standard preventive measures: NR

 Intervention: 5/31 

(16.1%)

 Control: 5/29 (17.2%)

 P=0.6460

RISK FACTORS FOR 

INFECTION

Gastric Surgery

No significant risk factors 

were identified 

affecting either wound 

infection or SSI rates in 

the univariate analysis 

using the logistic 

regression model in 

gastric surgery.

Colorectal Surgery 

Univariate Analysis of Risk 

Factors

Wound Infection

 ASA: OR = 3.4232; 

P=0.0436

 DM: OR = 5.6400; 

P=0.0573

 

SSI

 ASA: OR = 3.7093; 

P=0.0206

 DM: OR = 7.6667; 

P=0.0162

Multivariate Analysis of 

Risk Factors

Wound Infection: OR (95% 

CI)

 ASA: 2.9039 (0.752-
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and should not be construed to represent any agency determination or policy. 241

Author

Year

(Data 

Extractor)

Risk of 

Bias 

Score

Study Objective Population and Setting Intervention Results Comments

Setting: 1 medical center

Location: Japan

Dates: July 2004 –

December 2004.

Inclusion Criteria:

Patients undergoing 

gastric or colorectal 

surgery between July 

2004 and December 

2004

Exclusion Criteria: NR

11.211)

 DM: 3.8966 (0.637-

23.834)

 P = 0.0452

 

SSI: OR (95% CI)

 ASA: 2.6602 (0.6660-

10.725)

 DM: 3.8336 (0.574-

25.617)

 Smoking: 2.1090 (0.382-

11.644)

 Wound Class: 1.7113 

(0.153-19.185)

 P = 0.0452

Other infections: NR

Topic-specific outcomes:

Gastric surgery:

No relation was identified 

between wound 

infection or SSI rates 

and skin or 

subcutaneous tissue 

positive cultures in 

gastric surgery.

Colorectal surgery:

Wound infection and SSI 

occurred in 2 of 5 skin 

culture positive cases.

Wound infection and SSI 

occurred in 4 of 7 

subcutaneous culture 

positive cases (2 same 

as in skin culture) and 

showed statistical 
Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminated by the Centers for Disease Control and Prevention 

and should not be construed to represent any agency determination or policy. 242

Author

Year

(Data 

Extractor)

Risk of 

Bias 

Score

Study Objective Population and Setting Intervention Results Comments

significance:

COLORECTAL SURGERY:

 Culture Positive: 7 cases

 Culture Negative: 53 

cases

Wound Infection

 Culture Positive: 4/7 

(57.1%)

 Culture Negative: 4/53 

(7.5%)

 P=0.0042

SSI 

 Culture Positive: 4/7 

(57.1%)

 Culture Negative: 6/53 

(11.3%)

 P=0.0115

Reoperations: NR

Length of stay: NR

Mortality: NR

Adverse events: NR
Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminated by the Centers for Disease Control and Prevention 

and should not be construed to represent any agency determination or policy. 243

RISK OF BIAS ASSESSMENTS OF STUDIES Q8-10

Systematic Reviews

Author

Year (RefID)

KQ Search 

terms 

described

Databases 

described 

and two 

or more 

databases 

searched

Inclusion/ 

exclusion 

criteria 

described

Number of 

included/ 

excluded 

studies along 

with reasons 

of exclusion 

described

Studies 

screened 

by two 

independent 

reviewers 

for inclusion

Data 

extracted 

by two 

independent 

reviewers

Individual 

study 

quality 

assessed

Heterogeneity 

between study 

results assessed 

qualitatively 

and/or 

quantitatively

Publication 

bias 

assessed

Characteristics 

of included 

studies 

reported in 

evidence table

Funding 

source(s) 

disclosed 

and no 

obvious 

conflict of 

interest

Overall 

Risk of 

Bias

Key Question 8-10: Antiseptic Prophylaxis

Webster

2007 69 8           Low

Randomized Controlled Trials

Author

Year (RefID)

KQ Described 

as 

randomized

Randomization 

appropriately 

performed

Described 

as doubleblind

Outcome 

assessor 

blinded

Study 

participant 

blinded

Investigator 

blinded

Attrition 

described

Attrition smaller

than 10-15% of 

assigned patients

Attrition 

appropriately 

analyzed

Funding source(s) 

disclosed and no 

obvious conflict of 

interest

Overall 

Risk of 

Bias

Key Question 8-10: Antiseptic Prophylaxis

Berry

1982 90 8       Low

Bibbo

2005 87 8   High

Chang

2006 100 9         Low

Cheng

2009 88 8    Moderate

Cheng

2005 101 9        Low

Chiu

1993 96 8  High

Darouiche

2010 85 8           Low

Dewan

1987 99 8      Low

Ellenhorn

2005 78 8    Moderate

Gilliam

1990 80 8    Moderate

Harihara

2006 107 10  High

Hort

2002 83 8    Moderate

Iyer

2011 93 8      Low
Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminated by the Centers for Disease Control and Prevention 

and should not be construed to represent any agency determination or policy. 244

Author

Year (RefID)

KQ Described 

as 

randomized

Randomization 

appropriately 

performed

Described 

as doubleblind

Outcome 

assessor 

blinded

Study 

participant 

blinded

Investigator 

blinded

Attrition 

described

Attrition smaller

than 10-15% of 

assigned patients

Attrition 

appropriately 

analyzed

Funding source(s) 

disclosed and no 

obvious conflict of 

interest

Overall 

Risk of 

Bias

Jackson

1971 97 8   High

Ostrander

2005 91 8    Moderate

Paocharoen

2009 86 8  High

Psaila

1977 98 8    Moderate

Roberts

1995 82 8      Low

Rogers

1983 103 9      Low

Saltzman

2009 81 8    Moderate

Segal

2002 79 8     Moderate

Sindelar

1985 106 9      Low

Sindelar

1979 102 9     Moderate

Sindelar

1979 104 9      Low

Sistla

2010 84 8       Low

Towfigh

2008 94 8          Low

Veiga

2008 89 8  High

Veiga

2008 77 8   High

Vallance

1985 105 9     Low

Von Eckardstein

2011 92 8       Low

Ward

2001 95 8          Low
Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminated by the Centers for Disease Control and Prevention 

and should not be construed to represent any agency determination or policy. 245

SECTION 3: EVALUATION OF THE RISK OF BIAS OF AN INDIVIDUAL STUDY

Instructions

Check off each item in the appropriate checklist if it is present in the study

Divide the total number of checked items by the total number of questions on the checklist 

Rate the risk of bias as follows: 

% of Items Present in Study Risk of Bias

< 25% High

> 25% and < 50% Moderate

> 50% Low

CHECKLIST FOR SYSTEMATIC REVIEWS

1) Search terms described

2) Databases searched described and two or more databases searched

3) Inclusion/exclusion criteria described

4) Number of included/excluded studies along with reasons of exclusion described

5) Studies screened by two independent reviewers for inclusion

6) Data extracted by two independent reviewers

7) Individual study quality assessed

8) Heterogeneity between study results assessed qualitatively and/or quantitatively

9) Publication bias assessed

10) Characteristics of included studies reported in evidence table

11) Funding source(s) disclosed and no obvious conflict of interest

CHECKLIST FOR RANDOMIZED CONTROLLED TRIALS

1) Described as randomized

2) Randomization appropriately performed (e.g. random number table, computerized scheme)

3) Described as double-blind

4) Outcome assessor blinded

5) Study participant blinded (e.g. interventions identical in appearance)

6) Investigator blinded (e.g. opaque sealed envelopes)

7) Attrition described

8) Attrition smaller than 10-15% of assigned patients

9) Attrition appropriately analyzed (e.g. intention to treat analysis)

10) Funding source(s) disclosed and no obvious conflict of interest
Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminated by the Centers for Disease Control and Prevention 

and should not be construed to represent any agency determination or policy. 246

CHECKLIST FOR OTHER CONTROLLED STUDIES

1) All study groups derived from similar source/reference populations

2) Attrition not significantly different across study groups

3) The measure of exposure is valid

4) The measure of outcome is valid

5) Investigators blinded to endpoint assessment

6) Potential confounders identified

7) Statistical adjustment for potential confounders done

8) Funding source(s) disclosed and no obvious conflict of interest

TRANSLATING RISK OF BIAS INTO GRADE TABLES

When the risk of bias was rated as “High” for >75% of studies making up the evidence base for a given outcome, one point was deducted for Study Quality in 

the GRADE table.
Disclaimer: This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminated by the Centers for Disease Control and Prevention and should not 

be construed to represent any agency determination or policy. 247

SECTION 4: EVIDENCE TABLE EXTRACTION TEMPLATES

1. SYSTEMATIC REVIEW (SR) EXTRACTION TEMPLATE

Author

Year

(Ref ID_

Data 

Extractor

Risk of 

Bias 

Score

Study Objective Population and Setting Intervention(s) Results (by intervention) Comments

SR

Quality 

Score

Narrative Study types and number

Number of total patients in 

the review

Inclusion criteria

Exclusion criteria

Databases searched

Aggregate summary score 

Intervention group

Timing of intervention

Duration of intervention

Device

Monitoring intervention

Control group

Standard preventive measures 

SSI 

Other infections

Topic-specific outcomes

Re-operations 

Length of stay

Mortality

Adverse events

Definitions 

Perioperative care 

Other notes

Follow up

2. RANDOMIZED CONTROLLED TRIAL (RCT) EXTRACTION TEMPLATE

Author

Year

(Ref ID_

Data 

Extractor

Risk of 

Bias 

Score

Study Objective Population and Setting Intervention Results Comments

RCT

Quality 

Score

Narrative Number of patients

Patient Characteristics

·Age

·Gender

·Obesity

·Comorbidities

Procedures

Indications

Setting

Location

Dates

Inclusion Criteria

Exclusion Criteria

Intervention group

Timing of intervention

Duration of intervention

Device/agent

Monitoring intervention

Control group

Standard preventive measures 

SSI 

Other infections

Topic-specific outcomes

Reoperations 

Length of stay

Mortality

Adverse events

Definitions 

Perioperative care 

Other notes

Follow-up 
Disclaimer: This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminated by the Centers for Disease Control and Prevention and should not 

be construed to represent any agency determination or policy. 248

3. OTHER CONTROLLED STUDIES EXTRACTION TEMPLATE

Author

Year

(Ref ID)

Data 

Extractor

Risk of Bias 

Score

Study 

Objective Population and Setting Intervention Results Comments

Study Design

Quality Score

Narrative Number of patients:

Patient Characteristics: 

·Age: 

·Gender: 

·Obesity: 

·Comorbidities: 

Procedures: 

Indications: 

Setting: 

Location: 

Dates: 

Inclusion Criteria: 

Exclusion Criteria: 

Intervention group: 

Timing of intervention: 

Duration of intervention: 

Device/agent: 

Monitoring intervention: 

Control group: 

Standard preventive measures: 

SSI () 

Other infections: 

Topic-specific outcomes: 

Reoperations: 

Length of stay: 

Mortality: 

Adverse events: 

Definitions: 

Perioperative care: 

Analytical 

methodology:

Other notes: 

Follow-up: 
Disclaimer: This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminated by the Centers for Disease Control and Prevention and should not 

be construed to represent any agency determination or policy. 249

SECTION 5: STUDY TYPE DETERMINATION ALGORITHM

Adapted from: Hartling et. al 2010

Was there some kind of comparison? Case series: the study describes the clinical course of a group of individuals with a particular diagnosis, condition, or exposure; if the group is <5 individuals, it is called a case report instead

Was information on the intervention/ exposure and the outcome(s) gathered at the same time? Cross-sectional study: the study assesses the exposure/intervention and outcome(s) concurrently. Temporal cause and effect cannot be determined.

Did the investigators have control over study conditions such as: allocation to groups, timing of interventions/ exposures, and timing of outcome assessments?

Were interventions/ exposures assigned randomly?

Randomized controlled trial Non-randomized controlled trial

No Yes

No

Yes

Yes

Yes

No Did all of the enrolled patients receive the same intervention/ exposure? No

No

Were groups defined by the intervention/ exposure? Was the intervention/ exposure information collected prior to the outcome occurring? No Case-control study: participants are selected based on known outcome. Exposure/intervention status is compared between groups of those who have the outcome of interest (cases) and those who do not have the outcome of interest (controls). Nested case-control study: Participants are selected from a single-source population (consecutive patients from the same setting, all patients during a particular time period) and exposure/intervention status noted at baseline. The participants are then followed over time and the outcome of interest is noted.

No

Yes

Yes

Were there more than 3 measurements of outcomes both before and after the intervention/ exposure?

Pre-post study: the outcome of interest is measured both before and after the intervention/exposure in the same group of individuals. Interrupted time series: multiple observations over time in the same group of individuals are “interrupted” by an exposure or intervention No

Yes

Yes Were participants selected from a single-source (consecutive patients from the same setting, all patients during a particular time period)? Yes Cohort study: can be either prospective or retrospective. Individuals are identified on the basis of a common feature (such as setting) and are classified according to exposure/intervention status, and then followed over time to measure outcomes.

Were the groups concurrent? No Non-concurrent cohort study: groups of patients are identified on the basis of common features at different time points. The participants are classified according to exposure/intervention status, and then followed over time to measure outcomes No

Yes

Were there more than 3 measurements of outcomes both before and after the intervention/ exposure? Yes Controlled interrupted time series: multiple observations over time are “interrupted” by an exposure or intervention in a group compared to a group with no intervention/ exposure

No Controlled pre-post study: the outcome of interest is measured both before and after an intervention/exposure in a group compared to group with no intervention/ exposure
Disclaimer: This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminated by the Centers for Disease Control and Prevention and should not 

be construed to represent any agency determination or policy. 250

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