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

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

# Appendi x 1. Core Section

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

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

## Table of Contents

SECTION 1. SEARCH ST RATEGIES

................................ ................................ ................................ ................................ ................................ ........................ 4

SECTION 2: GRADE, EV IDENCE AND RISK OF B IAS ASSESSMENT TABLE S

................................ ................................ ................................ ........................... 6

Q1 PARENTERAL ANTIMI CROBIAL PROPHYLAXIS (AMP)

................................ ................................ ................................ ................................ ................ 6
GRADE T ABLE Q1

................................ ................................ ................................ ................................ ................................ ................................ ......... 6

EVIDENCE TABLE Q1

................................ ................................ ................................ ................................ ................................ ................................ .. 27

RISK OF BIAS ASSESSMENTS OF STUDIES Q1

................................ ................................ ................................ ................................ ............................. 93

Q2 NON

- PARENTERAL ANTIMICROBIAL PROPHYLAXIS

................................ ................................ ................................ ................................ ................ 96

GRADE TAB LE 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

................................ ................................ ................................ ................................ ................................ ................ 178Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y 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 I NDIVIDUAL STUDY

................................ ................................ ................................ ................... 245

CHECKLIST FOR SYSTEMATIC REVIEWS

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

................................ ................................ ................................ ................................ ................. 245
CHECKLIST FOR OTHER CONTROLLED STUDIES

................................ ................................ ................................ ................................ .......................... 246
SECTION 4: EVIDENCE TABLE EX TRACTION TEMPLATES

................................ ................................ ................................ ................................ ................ 247

1. SYSTEMATIC REVIEW (SR) EXTRACTION TEMP LATE

................................ ................................ ................................ ................................ ............... 247
2. RANDOMIZED CONTRO LLED TRIAL (RCT) EXTRACTION TEMPLATE

................................ ................................ ................................ ....................... 247
3. OTHER CONTROLLED STUDIES EXTRACTION T EMPLATE

................................ ................................ ................................ ................................ ........ 248

SECTION 5: STUDY TYPE DETERM INATION ALGORITHM

................................ ................................ ................................ ................................ ................ 249

SECTION 6: REFERENCES

................................ ................................ ................................ ................................ ................................ ................................ . 250Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y 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 43,081Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y 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 1,220Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

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

# SECTION 2 : GRADE
, EVIDENCE AND RISK OF BIAS A SSESSMENT T ABLES

Q1 PARENTERAL ANTIMICROBIAL PROPHY LAXIS (AMP)

GRADE T ABLE 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 Quality Consistency Directness Precision Publication Bias Large Magnitude

Dose - response Confounders

Q 1. 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 SSI

Endometri
tis* 1 SR 1  N=749 Mother s from 3 RCTs 2

, 3

, 4 all 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

inci sion High 0 0 0 0 0 0 0 0 High

High SSI
Incisional 1 SR 1  N=149 mothers from 3 RCTs 2

, 3

, 4 all undergoing cesarean section, overall RR: 0.60 (95%CI 0.30

- 1.21); P=0.151 1 indicating trend toward r eduction 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

, 4 all 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 n eonates did not show different causative organisms between groups or increased antimicrobial

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

and should not be construed to represent any agenc y 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 Quality Consistency Directness Precision Publication Bias Large Magnitude

Dose - response Confounders

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=0.9 9 High 0 0 0 0 0 0 0 0 High

NICU
Admission 1 SR 1  N=681 Neonates from 2 RCTs 2

, 3 all delivered by

Cesarean secti on, , 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

Q1 D . 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 co lorectal 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 fe cal 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 ModerateDisclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y 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 Quality Consistency Directness Precision Publication Bias Large Magnitude

Dose - response Confounders

gross contamination; p<0.05 (contamination unknown in 4). Study does not repo rt these infections by single dose versus redosed.

Intra

Abdomina
l Abscess 1 RCT 5  No difference: 8/146 (5%) vs. 1 0/132(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 opera ting 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 ModerateDisclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y 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 Quality Consistency Directness Precision Publication Bias Large Magnitude

Dose - response Confounders

min after induction of anesthesia and those whose procedures lasted >3h were redosed intraoperatively.

 The “no postoperative AMP” group also had statistically h igher 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.

Be tween 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

 How ever, 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 ModerateDisclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y 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 Quality Consistency Directness Precision Publication Bias Large Magnitude

Dose - response Confounders

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

– 3.4 5 ; 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 fol low 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

ca lculation of the overall infection rate. High 0 0 0

- 1 0 0 0 0 ModerateDisclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y 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 Quality Consistency Directness Precision Publication Bias Large Magnitude

Dose - response Confounders

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 b oth incisional SSIs were Staphylococcus aureus

 One study 26 i ncisional 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 ModerateDisclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y 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 Quality Consistency Directness Precision Publication Bias Large Magnitude

Dose - response Confounders

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

and should not be construed to represent any agenc y 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 Quality Consistency Directness Precision Publication Bias Large Magnitude

Dose - response Confounders

 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 3 2 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 ModerateDisclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y 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 Quality Consistency Directness Precision Publication Bias Large Magnitude

Dose - response Confounders

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

- ana lysis (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 wo und 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 minimu m 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 Lo w

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

and should not be construed to represent any agenc y 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 Quality Consistency Directness Precision Publication Bias Large Magnitude

Dose - response Confounders

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

Troc ar 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 8 n o di fference : 4.02 ±1.51 vs. 3.97±1.27

 One RCT 22 n o differences: 18 days (range 12

- 23) vs. 19 days (range, 12

- 23 days)

 One RCT 23 n o 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 ModerateDisclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y 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 Quality Consistency Directness Precision Publication Bias Large Magnitude

Dose - response Confounders

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 o f 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 ModerateDisclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

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

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 approximat ely 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 betwee n 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
f ollow 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 HighDisclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y 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 Quality Consistency Directness Precision Publication Bias Large Magnitude

Dose - response Confounders

no deaths r esulted 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 menti on 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 1 3 (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 HighDisclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y 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 Quality Consistency Directness Precision Publication Bias Large Magnitude

Dose - response Confounders

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
report ed 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 lap arotomy 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 Mod erate

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

and should not be construed to represent any agenc y 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 Quality Consistency Directness Precision Publication Bias Large Magnitude

Dose - response Confounders

≤24h

vs. 5 days SSI* 1 RCT 35  1 RCT (N=40) in patients with chronic ulcerative

co litis, 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 fa ctor associated with incisional SSI (p=0.002).

 1 RCT 17 1 subgroup anal ysis 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 HighDisclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y 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 Quality Consistency Directness Precision Publication Bias Large Magnitude

Dose - response Confounders

undergoing elective colorectal procedure s 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 10 n o difference: 5/190 (2.6%) vs. 9/187(4.8%); p=0.26. (30 day follow up)

 One RCT 19 n o 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 ModerateDisclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y 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 Quality Consistency Directness Precision Publication Bias Large Magnitude

Dose - response Confounders

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 Hig h HighDisclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y 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 Quality Consistency Directness Precision Publication Bias Large Magnitude

Dose - response Confounders

 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%) H igh

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

and should not be construed to represent any agenc y 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 Quality Consistency Directness Precision Publication Bias Large Magnitude

Dose - response Confounders

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 6 of 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 we re 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 ModerateDisclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y 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 Quality Consistency Directness Precision Publication Bias Large Magnitude

Dose - response Confounders

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

(2932 43 )  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 IntervalDisclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

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

and should not be construed to represent any agenc y 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. W hat is the optimal timing of preoperative AMP ? Our search did not identify RCTs or SRs that evaluated different timings of preoperative AMP administrat ion 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

Costa n tine

2008 1 ( 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
antimicrobial s 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 inc ision

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

and should not be construed to represent any agenc y 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 weight

adjusted 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 1991 5
( 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 orga nism 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 daysDisclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y determination or policy. 29 Author

Year (Data

Extractor ) Study

Design Quality

Score Study Objective Population and Setting Intervention Results Comments

elective
colorectal

surger y. Exclusion Criteria:

Patients known to be allergic to penicillin or
who had received
antimicrobial s in the
72 hours before their planned operation.

Patients were
excluded if th e large bowel was not opened at operation, if intra

abdominal 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 antimicrobial s were administered.Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y 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

2011 34
( ES) RCT

1, 2, 7, 8, 9 To establish t he 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: no t significant; Setting: 1 university hospital

Loc ation: 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 intraop eratively (based on procedure duration) Duration of
intervention: Pre and intraoperatively (vs. up to 4 days in controls) Device/agent : o xacephem 1g

IV antimicrobial Monitoring intervention: NR (Cultures of drainage or purulence were made) Control group: n=181 Oxacephem (1g)
antimicrobial was ad ministered 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 an d 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

p hlebitis 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 fi lms, sputum, urine, blood, or catheter
culture after

surgery. Perioperative care:

NR
Other notes: Non

inferiority margin is 10% ( Δ=0.10 )

. Based on this

, there were noDisclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y 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
obstructi on, 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

w as 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

- ele ctrolyte 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: Uri nary 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 (sing le 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 disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y 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
2008 7
( 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 (%)

Interve ntion: 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:

S ingle dose

pre operatively (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 disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y 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:

H ematocrit 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

Osteom yelitis 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 de ep 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

≥38 o C), or localized pain or
tenderness (unless the re sults
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 mediast inal
tissue or fluidDisclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y 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,

emerge ncy 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 S A 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

≥38 o C), sternal pain or instability,
mediastinal
involvement suggested by a computed tomographic scan, or organisms
cultured form the
mediastinal area
Sternal osteomyelitis

– An organ

- sp ace SSI indicated by persistent purulent drainage
from the sternotomy & confirmed by microbiologic and histopathologic findings.
Endocarditis

– Organ

space SSI characterized by
Duke’s criteria (Durack 1994) Perioperative care:

NR
Other notes:
SSI Risk St ratification : NNIS Statistical Analysis : Study powered toDisclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y 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 Fibrillatio n 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 hospitalDisclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y 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

Li u 2008 31
( ES) RCT

1, 2, 3, 4, 6, 7, 8, 10 To investigate the impact of
the duration of prophylactic
antimicrobials
on post

operative
wound
infection in patients undergoing major head and neck neoplasm operations and
to determine
associated factors in post

operat ive
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: A verage BMI
Intervention: 23.6 kg/m 2 Control: 23.6 kg/m 2

·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

a ntimicrobial (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 powerDisclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y 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/ Laryn x/ 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 postoperativelyDisclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y 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 woul d 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%) polymic robial 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 even ts: 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 disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y determination or policy. 39 Author

Year (Data

Extractor ) Study

Design Quality

Score Study Objective Population and Setting Intervention Results Comments

Fujita

2007 10
( ES) RCT

1, 2, 7, 8, 9, 10 To determine

the efficacy of a single

- dose regimen of
second

generation cephalosporin
cefmetazole
without

me tronidazole
and oral
antimicrobial s 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: c efmetazole 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: 27/1 90 (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 confusi ng 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 note s: 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
d ifference between groups
and enrollment was stopped. Significance at

<0.05
Follow

- up: WoundsDisclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y 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
inf ectious 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 w ith 2L polyethylene glycol

electrolyte solution 1 day before surgery. No oral
AMP was administered as part of the bowel prep The incidence of incisional
SSI associated with laparoscopic s urgery 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 disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y determination or policy. 41 Author

Year (Data

Extractor ) Study

Design Quality

Score Study Objective Population and Setting Intervention Results Comments

admini stration 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

2007 43
( ES) RCT

1, 4, 6, 7, 8, 9, To compare the

efficac y 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/m 2
(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 intra venous infusion

over 15 minutes. An
additional dose was
administered if the operation was prolonged beyond 3h. Timing of intervention: Preop and int raop 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 Defin itions: 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 theDisclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y 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 (1 0

- 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

- s ulbactam:

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 antib iotics 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 w ith 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 inter vention 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
tendern ess, localized swelling, redness, heat or fever (38 o C)

 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

exami nation. Organ/space SSI : Infection occurring within 30 days after operation and involving the intra

abdominal cavity
and at least one of the following:

 Purulent discharge from a drain placed through a stab
wound into the

intra

- abdominal cavity

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

and should not be construed to represent any agenc y 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

cent ers. 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 resec tion 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 le vel 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

cover ed 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 radiogra phic

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 disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y determination or policy. 44 Author

Year (Data

Extractor ) Study

Design Quality

Score Study Objective Population and Setting Intervention Results Comments

Togo
2007 44
( 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 diffe rences 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 o f 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, followe d 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 d eep 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 MedicineDisclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y 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:

Patie nts 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

surger y. 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 antimicrobial s 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
Interventio n: 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:

Treatme nt: when post

operative 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 ≤ 36 o C and ≥38 o C

 A pulse rate of ≥90/min

 A respiratory rate of ≥ 20/min or

PaCO 2 > 32 torr

 White blood cell
counts of ≥12,000/mm 3 and ≤4,000/mm 3 or ≥10% immature
cells
Bili ary 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 intra

abdominal
accumulation of bile confirmed by
percutaneous drainage

 Cholangiographic
evidence of bileDisclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y 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

2006 12
( 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
Procedure s: mix of clean orthopedic fracture surgeries Setting: 1 public hospital
Location: Pakistan

Dates: April 2004

– March 2005
Inclusion Criteria: A ny 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: c eftazidime. 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.

Wou nd 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 disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y 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

antimic robial s 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

2005 6
( ES) RCT

1, 6, 7, 8, 9 To investigate
the infective complications rate after open appendectomy
for non

perforated appendicitis ( NPA ) receiving
different
durations of prophylactic
antimicrobial s cefuroxime and
metronidazole perioperative regimens : 1) single dose preoperative, Number of patients:

N=269
Patient C haracteristics : 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 genera l anesthesia followed by
two more doses of IV
antimicrobial s. 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

c ollection or
abscess: a fluid
collection diagnosed at
ultrasound or computed tomography which required drainage C. difficile
enterocolitis

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

and should not be construed to represent any agenc y 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

- day s 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 non

perforated appendic itis 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:

Patie nts who had a history of preadmission
antimicrobial s, 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
antimicrobial s. IV
Anti microbials were administe red until patients could tolerate a

semi

- solid or solid diet
when IV antimicrobial s 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 intra

abdominal collection or
abscesses.
Othe r infections: NR Topic

- specific outcomes:
The incidence of AMP

related 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 (<37 o C tympanic), and had adequate pain control on oral analgesics.
Other notes: Study is underpowered

Patients were
randomized after

open appendectomy
determined NPA
Follow

- up: A fter discharge a ll patients were followed up at 10 days postoperatively
for wound
assessment and
stitches removal
and the second follow up was
conducted forDisclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y determination or policy. 49 Author

Year (Data

Extractor ) Study

Design Quality

Score Study Objective Population and Setting Intervention Results Comments

antimicrobial s, 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 treate d 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

2005 33
( ES) RCT

(pilot study) 1, 2, 9,

10 To investigate
whether a short
course of
antimicrobial s (<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 Characterist ics:
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 in fection (Sharpiro 1982) Urinary tract infection (UTI) : diagnosed from patients’ symptoms andDisclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y 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

- J uly

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
antimicrobial s and
other associated surgical procedures
were excluded from and postoperatively
Duration of intervention:
From 1 hou r 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 8 0mg 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 dis charge)

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
differen ces 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’ chartsDisclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y determination or policy. 51 Author

Year (Data

Extractor ) Study

Design Quality

Score Study Objective Population and Setting Intervention Results Comments

the study

Su
2005 8
( ES) RCT

1, 2, To compare the efficacy of a single

- dose

versus a 1

- day
course of

pr ophylactic
antimicrobial s for postoperative
wound
infection
outcomes and

cost

effectiveness 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/m 2
(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 be fore 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 throu gh 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

Intervent ion: 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 f rom LAVH

surgery

Other infections: Fever (> 38.5 o C 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

38.5 o C, 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:
AnesthesiaDisclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y 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

- assist ed 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 betwe en groups regarding preoperative examination and preparation, skin disinfection, postoperative
intr avenous fluid therapy (for 36h only), and indwelling urethral catheterization (for 24 h only). Skin Prep: The surgical site was prepared by swabbing with povi done

iodine 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. fra gilis 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 st ay: 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, physicalDisclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y 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

antimicr obial therapy during the study. Also, patients who had
taken antimicrobial s the week before

surgery examination, and pelvic sonography were performed when patient
returned to the
clinic for
evaluation.

Carroll

2003 32
( 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 free

flap

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

and should not be construed to represent any agenc y 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:

F ibula/jejunum/radial forearm/rectus: 9/19/31/15 Tumor site: Buccal/floor
of

m outh/hypopharynx/ larynx/maxill a/ oropharynx/roof of mouth/ tongue: 5/15/14/7/11/8/10/4
Procedures: Surgical
ablation of head and neck malignancies
with immediate free

flap recons truction 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:

Pati ents 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

s a mple size for 2 sided significance level of 0,005 with 80% power would require more than 10,000 subjects in
each treatmentDisclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y 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 free

flap reconstruction
Exclusion Criteria: Patients undergoing secondary
reconstruction and
those whose tumor
did not involve the
mucous membranes o f the upper
aerod igestive tract arm. Follow

- up: Wounds
were evaluated daily for 7 days postoperatively (or until discharge) by a blinded faculty
head and neck

surgeo n.

Hall

1998 30
( 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/m 2 ) Intervention: 25 (22

- 27) Control: 24 (22

- 27)
·Comorbidities

IDDM: Intervention: 3 (2%) Int ervention 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 4 2 days postop)
Overall rate of wound morbidity: (wound + minor wound): 10 1 /302 (34%)

Wound infection : 43/302 (14%) Intervention: 28 (18%) Control: 15 (10%)

P=0.04 1
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
infectionDisclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y 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

Int ervention: 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 s hock,
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 & Dr ains:
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 isola tes 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 onDisclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y 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

p atien t:
1: 8 6 ( 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

I CU 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 surgeryDisclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y 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. antimicrobial s 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 a ntimicrobial regimen.
Procedures: Elective and emergency intra

abdominal 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

t ypes of intra

abdominal 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
cefotaxim e 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 sufficient ly 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 disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y 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
antimicrobial s. Also if operative findings
indicated the need for prolonged

antimi crobial s, 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

ce fotaxime 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 (non

antimicrobial ) bowel prep of up to 3 L of a c olonic 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

sma ll 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: 3/76Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y 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 patient s 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.
Exclusio n 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 foll owed 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 dischargeDisclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y 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 r oom , 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% us ing 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

s ternum 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 microorganismsDisclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y 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 vei ns 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 intra

cutaneous 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 (≥10 5 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 byDisclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y 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

cor onary 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, hyper sensitivity 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

Int ra

- aortic balloon pump: 8/6
Artificial ventilation >24h: 7/10 Death within 7d (non

infectious): 1/8 ( all died
in OR or did not come off IABP)
Additional antimicrobial s: 15/3 Other operative procedure: 0/5 No wound inspection: 1/1 They report that neither
wound infection nor
mediastinitis oc curred 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 physicianDisclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y 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 deliver ed intravenously at the
moment of induction of
anesthesia. A second dose was systematically SSI: (follo w 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 (>38 o C) 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+ fistu l a)

Pneumonia: defined
on the basis of the

x

- ray film with speci fic parenchymal
features
associated with
temperatures between 37.5 o

– 38 o C.

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 x

ray film
associated with a
temperature higher than 38 o C.Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y 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(rang e) 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 hou rs.

. 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: Pathogen s 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 38 o C.

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

and should not be construed to represent any agenc y 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 > 38 o C, 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,
chroni c renal insufficiency, or β

lactamase 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: im i penem Control g roup: 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:Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y 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
all ergy to any study drug, concomi tant infection, serious comorbidity or inflammatory bowel disease. Also, patients
who had been treated
with antimicrobial s 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
Adv erse 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
antimicrobial s prophylaxis with multiple

dose 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 o f stay:
No differences: Definitions: NR Perioperative care:

nr Other notes: none Follow

- up: 8 days
postopDisclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y 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,

rece ived
antimicrobial s 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 antimicrobial s given on induction of
anesthesia Timing of intervention: Pre and post op
Duration of intervention: 1 pre op dose or 16h
postop. Device/agent: a ugmentin (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 Sub

Population: (n=247):
1 do se: 11/114 (9.6%) Definitions : Wound sepsis: Major
minor or late Perioperative care:

NR
Other notes: None
Follow

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

and should not be construed to represent any agenc y 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

in testinal obstruction including that due to strangulated hernia
were entered into the study as well as patients with intra

abdominal malignancy Setting: 2 General Hospitals
Location: United Kingdom

Dates: May 1986

– June

1988
Inclusion Criteria: All patient s 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

antim icrobials within the previous 48h or if the surgeon Three doses of antimicrobial s 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=0.16Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y determination or policy. 70 Author

Year (Data

Extractor ) Study

Design Quality

Score Study Objective Population and Setting Intervention Results Comments

considered that pre

operative
antimicrobial
administration were essential, they were also excluded. Also,
declination of consent was excluded although
all received prophylactic
antimicrobials

. Patients fo und 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 undergoi ng gynecologic procedures (abdominal and vaginal hysterectomy and myomectomy.) Intervention group: n=385 1dose: 1g cefotaxime intravenously 30 min before incision and might
be re peated 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).Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y 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 β

lactam sensitivity, treatment with any
antimicrobial in the 7 days preceding surgery, requirement
for combination
antimicrobial

treatm ent 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 gi ven 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 diagnosisDisclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y 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 befor e the operation, use of perioperative
antimicrobial
administration other than cefuroxime, malignancy, former or current sepsis in the joint and the use of gentamicin

impregnated 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, intra

abdominal abscess, or septicemia. Perioperative car e : NR
Other notes: None
Follow

- up: within 1
monthDisclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y 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
infection s. 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 s urgery 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. Standar d 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
antimicrobial s 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

receiv ed 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 pla cebo 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
materialDisclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y 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 w ater 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

pos t discharge when loop ileostomy was
closed. Patients
were then
followed for 12
months after
closure.Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y 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 antimicrobial s; 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 u p 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 yearDisclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y 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 ind uced, 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 superfi cial 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
Prosth etic 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 non

infected 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 disc harge
and wounds that
drained culture

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

and should not be construed to represent any agenc y 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, χ 2 = 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,

pr evious 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 multi

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

and should not be construed to represent any agenc y 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, electiv e 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

a bdominal surgery at one of 2 hospitals.
Exclusion Criteria: Postop antimicrobial Intervention group: n=519 patients given 1 1g
moxalactam intravenously at induction
of anesthesi a 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 colorect al: 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 pathogenicDisclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y 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
d ose 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.
Ski n 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
foun d 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

ra tes. 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
infection

Number 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 smalle r 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 upDisclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y 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 un dergoing 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 relatio nship
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.
Procedur es: 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
antimicrobial s 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 thes e 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 st art 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 daysDisclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y determination or policy. 8 1 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
antimicrobial s 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: NRDisclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y 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, undergoi ng elective colorectal surgery during the study
dates.
Exclusion Criteria: Patients receiving
antimicrobial s 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 day s Device/agent:
metronidazole &

a mpicillin 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 a bscess: 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
Abscess

intraperitoneal or pelvic collection of pus with
spontaneous discharge or which required

surg ical drainage.

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

and should not be construed to represent any agenc y 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 t he 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 one

shot regimen of
antimicrobial s. 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. Int ervention 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

m easures: 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 : NRDisclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y 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 w ere 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 tha t 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 antimicrobial s. Intervention gr oup: 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 interventi on 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 gro ups 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 str ains 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 disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y 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 single

dose regimen
of intravenous
antimicrobial s. 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

eme rgency or elective surgery during the study dates if the operation was
classified as “clean

contaminated” or
“contaminated” according to the NRC criteria; or when a vascular operation was planned (“Clean” operation)
Exclusion Criteria: patients with multi ple
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 monthDisclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y determination or policy. 86 Author

Year (Data

Extractor ) Study

Design Quality

Score Study Objective Population and Setting Intervention Results Comments

receiving
antimicrobial s for
reasons other than prevention of wound infections, or who had severely impaired
renal function or
known hypersensitivity to one of the study
antimicrobial s. Al so 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 ab dominal surgery involving opening of the colon.
Exclusion Criteria:
Patients who were to have appendectomies,

t hose 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: NRDisclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y determination or policy. 87 Author

Year (Data

Extractor ) Study

Design Quality

Score Study Objective Population and Setting Intervention Results Comments

to 48h. hypersensitivity to

o rnidazole or aminoglycosides,
those who received
antimicrobial
treatment less than 5d before the operation
and t hose with pre

operative 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.

Pati ents 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

– Febru ary 1982
Inclusion Criteria:
Patients who
underwent elective Intervention group: n=22 Patients receiving only a pre

operative 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%)

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

and should not be construed to represent any agenc y 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
antimicrobial s in the preceding 2 weeks and patients with inflammatory bowel
disease who had abscesses, fistul as or toxic dilatation of the
colon. Standard preventive

measures: Bowel prep consisted of

m agnesium s ulphate 2g TDS for 3 days before the operation and a standard
mechanica l method of bowel prep containing no
antimicrobial s.

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 Int ervention 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

meas ures: 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 upDisclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y 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 : Pat ients scheduled for
an aortic bifurcation graft; patients having
received
antimicrobial s 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
chlorhexi dine soap 3 times on day prior to

surgery. Hair removal: shaving immediately prior to

surgery.

Hemsell

1984 23
( ES) RC T

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 aller gy 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 i ntervention: 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 10 5

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

and should not be construed to represent any agenc y determination or policy. 90 Author

Year (Data

Extractor ) Study

Design Quality

Score Study Objective Population and Setting Intervention Results Comments

cephalosporins, cephamycin s , 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 38 o C during
the 24h before

surgery, conco mitant 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
posto p.

Standard preventive

m easures: 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. Tendernes s was always asymmetrical. Perioperative care :
NR
Other notes : none Follow

- up: 3

- 6 weeks post

surgery. 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.

Dura tion 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: 1/4 7 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 coll ected 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 operationDisclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y 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 cepha losporins, 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 discha rge. 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 4 th
day postop Device/agent : cephalothin Control group : n= 34
20 dose: 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
dra inage 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,Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y 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 penicil lin in doses greater than 400,000 units/day or any other
antimicrobial s 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
de viations from the protocol or apparent allergy to the protocol drug. Standard preventive

mea sures : 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 yearsDisclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y 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 Indiv idual

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
in terest 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 double

blind 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     ModerateDisclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y determination or policy. 94 Author Year (RefID) KQ Described

as randomized Randomization

appropriately performed Described

as double

blind 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   HighDisclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y determination or policy. 95 Author Year (RefID) KQ Described

as randomized Randomization

appropriately performed Described

as double

blind 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     ModerateDisclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y 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 i n 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 smal l (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 LowDisclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y 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

Q2 C. How safe and effective are a ntimicrobial

- coated sutures; when and how should they be used?

Antimicrobial

coated suture (absorbable) SSI* 4 RCT 51

,

52

, 53

, 54  In a meta

- analysis (N=42 0 ) 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 HighDisclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y 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 Non

antimicrobial

coated 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. 5/4 3 (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 sm all (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 w as not specified.

 1 small (N=8 4 ) 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 ModerateDisclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y 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 sp ecified endpoints
Adverse

events

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

and should not be construed to represent any agenc y 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 R CTs 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/m 2
(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 wou nd
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

- s pecific 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 expecte d
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,Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y 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: CABG

related open saphenectomy
Indicati ons: 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: harv est 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 acc ording 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 disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y 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/m 2

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

sur gical 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

sit e. 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 solutio n. 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 af ter 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.Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y determination or policy. 103 Author

Year ( Data

Extractor ) Study

Design Quality

Score Study Objective Population and Setting Intervention Results Comments

surgery including
those with diabetes mellitus, obesity (BMI>25kg/m 2 , active smoker, peripheral
vascular disease and heart failure according

to NYHA III

- IV.
Exclusion Criteria: Emergency operations, active
endoca rditis, 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
microb iologically 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 gro up: 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 re

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

and should not be construed to represent any agenc y determination or policy. 104 Author

Year ( Data

Extractor ) Study

Design Quality

Score Study Objective Population and Setting Intervention Results Comments

corrected

34.2 ○ C±1.4 vs. 34.4 ○ C±1.4; p=0.5

Peerbooms

20 09 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)

Con trol: 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
cl osure 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: Aut ologous 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

Interventi on: 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 res ident
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:Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y determination or policy. 105 Author

Year ( Data

Extractor ) Study

Design Quality

Score 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

≤150x10 9 /L, hemoglobin level ≤6.5mmol/L, BMI>33kg/m2, and systemic disorders such as diabetes, existing line and anti

coagulated with citrate
dextrose solution. Per patient a maximum of 9

- 30ml of platelet

- rich plasma was produced.

Monitoring intervention: NR
C ontrol 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
ortho pedic 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: N R
Adverse events: NR Knee incision was
dressed postoperatively wit compression bandag es 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 functionDisclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y determination or policy. 106 Author

Year ( Data

Extractor ) Study

Design Quality

Score Study Objective Population and Setting Intervention Results Comments

rheumatoid arthrit is, 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: parace tamol (3g daily) and diclofenac (50mg 3 times daily) with pantaprazol (40mg daily) for protection against
ulcers. Anticoagulant: subcutaneous injection of 0.3mL low

molecular

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

and should not be construed to represent any agenc y determination or policy. 107 Author

Year ( Data

Extractor ) Study

Design Quality

Score Study Objective Population and Setting Intervention Results Comments

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 port

site. Number of patients:

N=48
Patient Characteristics: ·Age mean (range): 38 (21

- 64) years
·Gender m:f: 418:30 ·Obesity
·Comorbidities
Procedures: Video

laparoscopic cholecystectomy (VLC)
Indications: uncomplicated
cholelithiasis Setting: 1 university hospital.
Location: USA

Dates: September 2006

– April 2007
Inclusion Criteria:
Patients with uncomplicated
cholelithiasis undergoing uncomplicated video

laparoscopic cholecystectomy (VLC)
Exclusion Criter ia: Acute cholecystitis with localized peritonitis; umbilical hernia;

immuno depressed 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 peri

umbilical 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 umbil ical 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 wereDisclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y determination or policy. 108 Author

Year ( Data

Extractor ) Study

Design Quality

Score Study Objective Population and Setting Intervention Results Comments

the peritoneal cavity during VLC; and perforation of the gallbladder during removal through the
umbili cus 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 a nd
of the skin wound with polyglycolic sutures

 Disinfection of the umbilical wound and peri

umbilical skin with iodopovidone first then with
0.9% saline solution.

Standard preventive

measures: Laparoscopic technique: Hasson open technique
AMP: IV administ ration 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

C ontrol: 4 (3

- 8) days. Mortality: NR
Adverse events: registered at 12, 24, 36 and 48h
after VLC and on
the 3 rd , 4 th , 6 th

, and 7 th post

- VLC day. For patients
dismissed before

3 rd postoperative day, there was an ambulatory outpatient c ontrol
on the 60 th day
post

- VLC, the possible presence
of incisional
hernia in the umbilical region was registered.Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y determination or policy. 109 Author

Year ( Data

Extractor ) Study

Design Quality

Score Study Objective Population and Setting Intervention Results Comments

Kamath

2005 46
( ES) RCT

1, 4, 6, 7, 8, 9, To study the

role of the topical

anti microbial 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
·Comorbiditi es : 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 3 rd
day postoperatively and
wound dressed with low adherence dressing (rayon absorbent pad with adhesive border) Timing of intervention: Intra and po stoperatively
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 : Interventio n: 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 SS I
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,Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y determination or policy. 110 Author

Year ( Data

Extractor ) Study

Design Quality

Score 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 , 6 th , 12 th and

30 th day postopDisclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y determination or policy. 111 Author

Year ( Data

Extractor ) Study

Design Quality

Score Study Objective Population and Setting Intervention Results Comments

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 sinu ses for up to
3 months but all eventually settled down
with oral antimicrobials and dressings.
Charalam

bous

2 003 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: Non

English studies

Databases searched: MEDLINE, Advanced MEDLINE, CENTRAL Intervention : Topical ampicillin

Comparison : Control 1: No concomitant systemic antimicrobial prophylaxis
Control 2: WITH concomitant systemic antimic robial treatment. The exact timing
of administration was not
described. Wound infection:
All results intervention vs.
control

– OR(95% CI) :

Topical antimicrobial s 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 antimicrobial s vs.

– no concomitant systemic
antimicrobial prophylaxis contaminated wounds (3 studies): 0.26 (0.14

- 0.51); Q for heterogeneity 17.53;Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y determination or policy. 112 Author

Year ( Data

Extractor ) Study

Design Quality

Score Study Objective Population and Setting Intervention Results Comments

(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
bl inded for outcome assessment, intention

- to

treat was not reported in
8 studies and not done in 1 study P<0.0001

Topical antimicrobial s + 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

compara ble 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%)

Intervent ion: 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) atDisclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y 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/m 2
Intervention: 23.9 (16.0

- 28.0) Control: 23.6 (18.2

- 34.0)
·Comorbidities: Excluded
diabet es, 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 hospital

approved consent and Device/agen t: Triclosan

coated 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

meeti ng 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

Criteri a) 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 day s 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.Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y 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 I I, 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 results

primary
effectiveness endpoint
evaluated at 30 days postop.Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y 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 pla nned 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:

Intrao peratively
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 timesDisclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y 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
·Ob esity 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/mm 3 ) (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 p reventive

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. Non

infected 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 sligh tly 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
monthsDisclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y 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 complica tions related to
suture were identified after 1 year of follow

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

and should not be construed to represent any agenc y determination or policy. 118 Author

Year ( Data

Extractor ) Study

Design Quality

Score Study Objective Population and Setting Intervention Results Comments

host, HIV, on immunosup pressive drug, malignancy, missed diagnosis intraoperative, history of allergy to the substance, or

pregnancy

Rozzelle

2008 52
( E S) RCT

1, 2, 3, 4, 5, 6, 7, 8, 9,

10 To determine
whether wound
closure with
triclosan

coated
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 su bcutaneous 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 2 nd 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 newDisclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y 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

i mplantation 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%)
Indi cations: 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

n eurosurgeons. AMP: all participants received preoperative

intravenous
antimicrobial s (cefazolin, or vancomycin if allergic to cephalosporins) Skin Prep: all patients received preoperative
chlorhexidine skin cleansing, povidone

iodine 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

- i mpregnated 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

we eks 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 a pparently
infection free at 6 months. Pathogenic isolates n=10

SSIs:
Intervention:

1 MRSA 1 coag ulase neg ative (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 infec tion and patients undergoing

revision >6
months after
randomization

were re

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

and should not be construed to represent any agenc y 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 congenita l 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.Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y 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 non

antimicrobial
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 fac tor not reported
Intervention 29%
Control: 33%
“The most common risk factors were obesity and chemotherapy”
Actual numbers not reported
Received IV
antimicrobial s (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: Triclosan

coated absorbable suture. Monitoring intervention: NR Control group: n=4 9

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 i nfections 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
firm ness), purulent discharge, pain,
and increased skin
temperature. Confirmatory
culture was not required. FLACC behavior pain
assessment scale
was used in non

verbal patients (infants) unable to provide reports of pain. (face, legs, activity, cry,
consolabi lity) Intraoperative handling: overall, ease of passage, first throw, tie down, security, hand, memory,

non

- fraying. Perioperative care:

NR
Other notes: Patient population at
each woundDisclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y determination or policy. 122 Author

Year ( Data

Extractor ) Study

Design Quality

Score Study Objective Population and Setting Intervention Results Comments

T aking 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 clean

contaminated 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, stret ch, 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
under gone 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 post

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

and should not be construed to represent any agenc y 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:

Interve ntion: 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 disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y 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, si lver, 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 disseminate d by the Centers for Disease Control and Prevention

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

## RISK OF BIAS ASSESSMENTS OF ST UDIES 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 Characteri stics

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 double

blind 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         LowDisclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

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

# Q 3 GLYCEMIC CONTROL

GRADE TABLE Q 3

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

Q 3 . How do perioperative blood glucose and hemoglobin A1C levels impact the risk of SSI and what are their optimal perioperative target levels in diab etic 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 h ours . B oth 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
de ep 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 in fection outcome variable: 19.2% vs. High 0 0

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

and should not be construed to represent any agenc y 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.

Hypo

glycemia* 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 S ICU, 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%, (9 5% 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) we re 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 IntervalDisclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

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

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

## EVIDENCE TABLE Q 3

Q 3 . 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

o utcomes 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)

·Com orbidities:

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: 2 nd generation cephalosporin
Transfusion threshold:
hematocrit<30% SSI
Intervention: 11.1%
Control: 16.7%

P=0.09

Other infections: NR Topic

- specific outcomes: Hypogl ycemia 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.

O ther 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 daysDisclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y 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
fai lure (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 surgeri es, 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:

Pr imary 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 ce nter 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 studyDisclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y 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 preventiv e 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 daysDisclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y determination or policy. 132 

## RISK OF BIAS ASSESSMENTS OF STUDIES Q 3

Randomized Controlled Trials

Author Year (RefID) KQ Described

as randomized Randomization

appropriately performed Described

as double

blind 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      LowDisclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

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

# Q 4

- 5 NORMOTHERMIA

GRADE TABLE Q 4

- 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

Q 4 . 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

mainte nance 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 s urgical 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 HighDisclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y 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 RCT 58 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 Mod erateDisclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y 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 wit h 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 achiev ed 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 dur ation 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 IntervalDisclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

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

## EVIDENCE TABLE Q 4

- 5

Q 4 . 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 pre

and 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
temperat ure 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 s core ASA1:29/103 (28.2%) ASA2: 50/103 (38.5%) ASA3:24/103 (23.3%)
More than 75% of Intervention: n=47

Mattress w armed to 40°C
2 hou rs 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 in tervention : 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 th e 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 Definiti ons: 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
antimicrobial s. 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
hom e)Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y 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 , flat us 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%)

C ardiac 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

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

and should not be construed to represent any agenc y determination or policy. 138 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

2001 57
( 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 aft er 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: 1 74/242

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
bla nket.
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 minimu m 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
statistical ly significant dif ference 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 tha t lasted 5 days and was treated with
antimicrobial s 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 a t 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%)
Sh aving <7h preop: 116/416 (27.9%) Shaving>7h preop: 183/416 (20%) Info missing n = 9Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y determination or policy. 139 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 long

term 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)

st andard preoperative care plus no warming
Standard Preventive

Measures : Antimicrobial prophylaxis

AMP: 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%
Numbe rs 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

que stionnaire (6/10 questionnaires returned)Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y determination or policy. 140 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
antimicrobial s : 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. non

smokers (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 >20Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y determination or policy. 141 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 pull

through 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

T hermal 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 an d after surgery”

– see details SENIC score (1/2/3) Intervention:3/95/6 Control:3/88/5 NNISS scores (0/1/2)

I ntervention: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 (allogen e ic blood)

Intervention: 0.4±1.0
Control 0.8 ± 1.2 Hypoth ermia 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

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

and should not be construed to represent any agenc y determination or policy. 142 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

<25 00 cells/mL, or the
loss of more than 20% of body weight), or
bowel obstruction. Transfusion: Leukocyte depleted blood at surgeon’s discretion

O 2 - supplemental, nasal prongs at 6L/min first 3hours postop, gradually
eliminated to maintainO 2 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 amoun t 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±2.0Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y determination or policy. 143 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)
Smoker s: 14.9±6.7 days

Non

- smokers: 12.9±5.0

P=0.02 Mortality: 30 days Intervention: 2/104(1.9%)Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y determination or policy. 144 

### Q 5

. 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 an d 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=0.47Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y determination or policy. 145 

## RISK OF BIAS ASSESSMENTS OF STUDIES 4

- 5

Randomized Controlled Trials

Author Year (RefID) KQ Described

as randomized Randomization

appropriately performed Described

as double

blind 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

Q uestion 4 : Normothermia

Kurz
1996 58 4         Low

Melling

2001 57 4        Low

Wong
2007 59 4        LowDisclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y determination or policy. 146 

# Q 6

- 7 OXYGENATION

GRADE TABLE Q 6

- 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

Q 6 . In patients with normal pulmonary function, how safe and effective is the perioperative use of increased fraction of inspir ed oxygen (FiO 2 ) in reducing the risk of SSI?

GENERAL ANESTHESIA (Intraoperative mechanical ventilation and postoperative non

- rebreathing facemask or nasal cannula for 2

- 6 h ours )

80% oxygen vs. 30% oxygen (Both groups
without nitrous oxide) SSI, all* 5 RCT 60

, 61

,

62

, 63

, 64  3 high quality RCT 60

, 61

, 62 totaling 1,010

colorectal (n=800) and open appendect omy (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 replace ment to avoid hypo or hypervolemia

 1 high quality RCT 6 3 in 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 ag gressive perioperative fluid

restriction. High 0

- 1 0 0 0 0 0 0 Moderate

Moderate

Organ

space infection 2 RCT 6 3

, 64  Organ space infections reported in 5% of 1395 patients, and comprised 28% of all SSI

 No difference between groups: 36/685 (5%) v s. 39/701 (6%) High 0 0 0

- 1 0 0 0 0 ModerateDisclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y determination or policy. 147 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 6 3

, 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 6 3

, 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 ASEP SIS scores

 2 RCTs 60

, 6 3 suggested 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 RCT 60

, 62

,

63

, 64  1% mortality reported in elective colorectal

surgery patients at 14days 60

, 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 6 3

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

and should not be construed to represent any agenc y determination or policy. 148 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 intraoperative ly (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 st udies 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 R CT (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: 3/8 0 (4%) vs. 1/80 (1%); OR 3.08 (95%CI, High 0 0 0

- 1 0 0 0 0 ModerateDisclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y determination or policy. 149 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% o f 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

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

and should not be construed to represent any agenc y 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  In 1 RCT (5170 68 ) of 274 lower limb vascular surgeries, multivariate analysis suggeste d 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

s upplemental (30%) oxygen group: 5.8% vs. 23.5%; OR:0.20 ( 95% CI, 0.04

- 0.95 ) ;p=0.04

 One lesser quality study (3181 67 ) 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 ModerateDisclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y 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 IntervalDisclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y determination or policy. 152 

## EVIDENCE TABLE Q 6

- 7

Q 6 . In patients with normal pulmonary function, how safe and effective is the perioperative use of increased fraction of inspir ed oxygen (FiO 2 

### ) in reducing the risk of SSI?

Author

Year ( Data Extractor) Risk of

Bias

Score Study

Objective Population and Setting Intervention Results Comments

Staehr

2011 64
( 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% r ange] or N (%) Age: 63y [37

- 81] Gender: m/f:43/59 Obesity: Median BMI: 34 kg/m 2 [30

- 44] BMI≥35kg/m 2 :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 pre

oxygenated with 100% FiO 2 until

tr acheal intubation. Patients were given 80% FIO 2 from
intubation until the end of surgery when 100% FIO 2 was given immediately before
extubation. FIO 2 was increased to ensure arterial oxygen above

94%. Postop: The first 2h after surgery patients received 80% FIO 2 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 O 2 was administrated according to clinical practice Timing of Intervention: Intra and Postoperatively
Duration of Treatment: I ntubation to 2 hours after surgery.
Device: Nonrebreathing facemask
with a reservoir

Control: n=111 Intraop: Patients were pre

oxygenated with 100% FiO 2 until
tracheal intubation. Patients were given 30% FIO 2 from
intubation until the end of SSI (Follow up 14 days postop)
Overall : 29%

In tervention : 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 (%SS I [upper 95% CI]) Underweight (BMI<18.5kg/m 2 ) 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/m 2
Morbidly Obese : BMI ≥ 35kg/m 2
Overweight : BMI= 25.0

- 29.9kg/m 2
Normal Weight : BMI= 18.5

- 24.9kg/m 2
Underweight: BMI<18.5 kg/m 2
Perioperative Care:
Anesthesia

- standardized, non

nitrous 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

po ssible Preoperative SSI Risk Stratification: SENIC 1/2/3/4Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y 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: 4 0/102 (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 Classifica tion 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/m 2

, scheduled for acute or surgery when 100% FIO 2 was given immediately before
extubation. FIO 2 was increased to ensure arterial oxygen above

94%. Postop: The first 2h after surgery patients received a mixture of O 2 (2 l/min) and air (14 l/min) through above face mask. 2 hrs.
afte r surgery, supplemental O 2 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 antimicrobial s 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 on ly once to replace
measured or calculated deficits aiming at body weight increase of less than 1kg. Blood loss was kg/m 2 ) Intervention: 17% [20%] Control:18% [21%] Over Weight (BMI 25.0

- 29.9kg/m 2 ) Intervention: 19% [24%]
Control:2 2% [28%] Obese (BMI 30.0

- 34.9 kg/m 2 ) Intervention: 30% [42%] Control:26% [36%] Morbidly Obese (BMI ≥35.0 kg/m 2 ) 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.Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y 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:

Intervent ion: 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%)Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y 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 repor ted below
are for the intervention Age: ≥ 18 (Mean: 73.5 [SD 11]) Gender (m/f): 78/59 Obesity: BMI, mean: 26 kg/m 2 (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% FIO 2 was delivered via face mask in the recovery room
and on the 1 st postoperative day.
On the 2 nd 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 2 nd postoperative day (at least 48hrs) Device:

A face mask for the 1 st day to deliver

30% O 2

. On 2 nd postop day, FIO 2 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 x

ray film

Perioperative Care: Shaving around intended surgical wound site done in operating room just before surgery.Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y 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/ 27 4 (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.)
Inclu sion Criteria: Adult patients who underwent oximeter every 4 hours for 1 st 2 days.

Control: n=137 Postop: Brea thed room air

Standard Preventative Measures:

AMP: A ntimicrobial 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%)

C ontrol: 12/51 (24%)

P =0.01 No differences in secondary outcomes between groups in
the sub

- group analysis BMI>25kg/m 2 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 healedDisclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y 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

oximete r 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 on e 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 patientDisclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y 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 insufficienc y: 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 hyper

oxygenation 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). Al l 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: FIO 2 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.
AS EPSIS score taken

Perioperative Care:
Anesthesia was introduced withDisclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y 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 low er 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: FIO 2 30% O 2 combined with
70%N. Postop: In recovery room, flow rate was 4L/min for 2 hou rs. Standard Preventative Measures: Antimicrobial prophylaxis

- : Preoperative antimicrobial s: aminoglycosides (gentamicin sulfate) and metronid a zole. When intraoperative findings indicated gangrenous or perforated appendicitis,
antimicrobial treatment laste d 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 (PO 2 ) 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, isoflu orane, 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 stayDisclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y 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 wit h 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 6 3
( 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: Pre

operative and perioperative characteristics compared and no statistically significant
difference found between groups. (data below listed for intervention) Intervention: n=690 Intraop: 100% FIO 2 at induction of
anesthesia until intubation. Then
80% FIO 2 from intubation until the end of surgery. Postop: The first two hours following intubation patients
received 80% FIO 2 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 asDisclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y 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)
Gende r: Men (no (%)): 228/690 (41.7%) Obesity: BMI, median (5

- 95%): 25kg/m 2
(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%)

D iabetes 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 O 2 &

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% FIO 2 at induction of
anesthesia until intubation. Then

30%FIO 2 from intubation until end of surgery. Postop: During the first two hours after surgery, patient received O 2 via Nonrebreathing mask w/ a
flow of 14L air & 2L O 2 per minute.

In both groups FIO 2 was increased if
h ypoxia 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 pre

Infection 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)

Interve ntion: 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 reasons

does 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, incisi on 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 necessaryDisclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y 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: 12 4 (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 lapa rotomy 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 p ost

- 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 disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y 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
anesth esia 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 high

concentration, 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 we re 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
antimicrobial s. 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.

A MP : 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: 9/6 9 (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
antimicrobial s 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 ≥38.5 o C within the first 24 hours postpartum

or>38.0 o C 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 gesta tional or chronicDisclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y 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/m 2
( 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 gener al were not excluded), clinical chorioamnionitis, & HIV
infection prophylactic antimicrobial s. 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 inf ections: 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 E stimated 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

n ausea/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 lo st 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 disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y 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 FIO 2 and resulting

PaO 2 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 FIO 2 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% FIO 2 Unadjusted univariate RR, 0.61; 95%CI 0.38

- 0.98; P =0.04
80%FiO 2 : 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 disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y 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%)

PaO 2 mmHg 1h post

- induction Intervention: 285.9 (96.6%) Control: 117.5(40.6%)

P<0.05

PaO 2 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.

Po stop 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%) FIO 2 , pulse oximetry were continuously monitored during the surgery and in the recovery

room. Arterial blood sample obtained 1h
after anesthesia induction to
evaluate PaO 2 ; another was again
2 hours after intubation.
Control: n= 143 Intraop: At intubation Oxygen/ air
mixture with an FIO 2 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
f low 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
antimicrobial s or antise ptics AMP: w/ metronidazole plus
cefoxitin or a 3 rd 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%)

C ontrol: 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 surgeryDisclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y 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,
diabete s 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
antimicrobial s in pa tients 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 allogen e ic 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 antimicrobial s nor antiseptics were used. Analgesic: Patients who reported
post

- op pain scor e 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 disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y 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 FIO 2 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 recorde d 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

O besity: 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: FIO 2 100% Intraop: 80% Oxygen (FIO 2 of 0.80)

FIO 2 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:

Du ring Transport: Intervention: Closed reservoir bag

mask system
Control: Nasal cannula In recovery : high

- flow nonrebreathing, humidified, aerosol delivery system with selector to provide stable FIO 2 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 : FIO 2 (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
eviden ce 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 antimicrobial s, 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>11 000μL

 Temperature>38.5 o C

 Radiological Evidence of
infection

 Extrusion of pus from site

 Positive culture from site

 New erythema andDisclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y 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 pro cedures 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: FIO 2 100% Intraop: 35% Oxygen (FIO 2 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
nonrebr eathing, 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%)

Contro l: 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 daysDisclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y 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 FIO 2 in excess of 0.35, patients with
severe chronic obstructive pulmonary disease (COPD) who were likely to experience respiratory depression at FIO 2 of 0.80 (minor COPD a cceptable), 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

expec ted 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 inci dent

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 inclu de presenting symptoms, wound appearance, culture results [if any] and prescribed treatment. Follow up phone calls withDisclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y determination or policy. 171 Author

Year ( Data Extractor) Risk of

Bias

Score Study

Objective Population and Setting Intervention Results Comments

collag en deposition,
and clinical healing

outcomes. b etween 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 m 2 :mean (SD) Intervention: 2.00 (0.20) Control:2.05 (0.30)
Comorbidities: C ardiac 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 post

anesthesia 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 (P
sc O 2 )
measured via silastic tonometer inserted subcutaneously in subject’s dorsal left upper arm
after anesthetic induction.

E quilibration and baseline established while patient on room air. Second equilibration at

30 minutes. P sc O 2 readings recorded at 1, 2, 18, and 36 hours postoperatively Wound healing evaluated by hydroxyproline content in a
subcutaneous polytetrafluoroethyle ne tube
removed on the 7 th 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 compli cations, 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 amo unts 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
documentatio n

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 cli nical
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 po st

- op via
medical record review &Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y 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 hour s, 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 kn own 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 culture

positive pus (Kurtz 1996)Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y 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

Interventio n: 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

e xtubation. 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 rate s: 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 W ound 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 groupsDisclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y 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%

Ot her

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 pull

through 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 pr otein 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.
Subcuta neous 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 unti l discharge then at a clinic visit15 days)Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y 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
antimicrobial s. AMP: IV for a mean of 2.7±2.3 days after skin incision. Mostly
metronidazole combined with cefazolin, cefamandole, amoxicillin, clavulanate or
mezloci llin. 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 stapl ed
Normothermia: I ntraoperative core Subcutaneous oxygen tension

mm Hg Intraoperative
Intervention: 109±43
Control: 59±15

P<0.00 1 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 daysDisclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y 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 aural

canal temps or axillary temps

measu red 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, * peri tonitis. Intervention: 5/250 (2%) Control: 12/250 (4.8%) p=0.14



### Q 7 . 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 intraope rative 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 disseminate d by the Centers for Disease Control and Prevention

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

## RISK OF BIAS ASSESSMENTS OF STUDIES Q 6

- 7

Randomized Controlled Trials

Author Year (RefID) KQ Described

as randomized Randomization

appropriately performed Described

as double

blind 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

2011 61 6          Low

Gardella

2008 66 6           Low

Greif

2000 62 6           Low

Meyhoff

2009 6 3 6           Low

Pryor
2004 65 6           Low

Staehr

2011 64 6           Low

Turtiainen
2011 68 6        Low

Whitney

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

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

# Q 8

- 10 ANTISEPTIC PROPHYLAXIS

GRADE TABLE Q 8

- 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

Q 8 . What are the most effective strategies for preparing the patient’s skin prior to surgery to reduce the risk of SSI?
Q 8 A. 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 (Byrne 70 and 9547

- Rotter 72 ) (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 dif ference 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 ModerateDisclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y 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 RCT 73

.

 1 large study 72 (N=1813) not included in the

meta

- analysis also found no difference reporting 5 patients in each group w ith 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, I 2 =60%.

 Only the largest (N=1315) RCT 71 reported reduction in SSI with 4% CHG: 62/68 9 (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
studies 74 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 HighDisclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y determination or policy. 180 Comparison Outcome Quantity and Type of
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Evidence

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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)

 Ea ch study used 4% CHG

 Heterogeneity for this comparison was significantly high: P<0.03, I 2 = 70%.

 Studies included outpatient and inpatient procedures, patients undergoing vasectomy 75

, p lastic surgery of the trunk 73 and elective bil iary 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 w ith 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 ModerateDisclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y determination or policy. 181 Comparison Outcome Quantity and Type of
Evidence Findings Starting

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for

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GRADE of
Evidence

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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 colonizati on, not SSI.

 Study used 10% povidone iodine solution High

- 1 0

- 1

- 1 0 0 0 0 Very Low Very Low

Q 8 B. 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 dif ference 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, CHG

alcohol 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 Product

related
adverse

events 2 RCT 85

, 86  One study 85 (N=849) reported 3 (0.7%) drug

related adverse events (pruritu s, erythema or both around the surgical wound) in each group (P>0.99) High 0 0 0 0 0 0 0 0 HighDisclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y determination or policy. 182 Comparison Outcome Quantity and Type of
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for

Outcome Overall

GRADE of
Evidence

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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 larg e (N=866) general surgery study 90 : 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 signif icant) with iodophor

- alcohol in large bowel and other laparotomy procedures.

 No difference in a study 89 of 250 elective, clean,

p lastic 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 (f ollow 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 surgeries 91 , 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 HighDisclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y determination or policy. 183 Comparison Outcome Quantity and Type of
Evidence Findings Starting

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for

Outcome Overall

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Evidence

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Dose - response Confounders

 In a study 81 of 100 arthroscopic shoulder surgeries, no infection s 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

Q 8 C. How safe and effective is the application of an antimicrobial sealant immediately following skin preparation?

Cyanoacrylate

based 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

High Adverse

events

product
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 di fficulty 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

Q 8 D. 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

Iodophor

impregnated 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: 0.6 6

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

and should not be construed to represent any agenc y 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

Q 9 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, re

dosed 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 studie s 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 clean

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

and should not be construed to represent any agenc y determination or policy. 185 Comparison Outcome Quantity and Type of
Evidence Findings Starting

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Evidence
for

Outcome Overall

GRADE of
Evidence

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Dose - response Confounders

 In meta

- analysis (N=90) of d irty 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

- analy sis (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 regimen s 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

event

product
related 3 RCT 104

,

101

, 103  One s tudy 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 HighDisclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y determination or policy. 186 Comparison Outcome Quantity and Type of
Evidence Findings Starting

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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 w ith 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 RCT 106 : 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 proce dures, 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 Incisi onal: 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 PlasmaDisclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y 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 IntervalDisclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y determination or policy. 188 

## EVIDENCE TABLE Q 8

- 10

Q 8 . 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 mammopla sty, 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 detergent

based 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 s aline. 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: NRDisclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y 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. Standa rd 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 October

November 2010) Quality assessment: Using the
Cochrane Collaboration Tool for assessing risk of bias, low risk of
bias for: Random sequence gene ration

– 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 Int ervention : Any type of antiseptic solution (any strength, any regimen, at any time before the surgery) used for preoperative tub

- or bed

bathing 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; I 2 =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; I 2 =60%
Chlorhexidine 4% vs. no wash (3 studies, N=1142): 0.82(0.2 6

- 2.62); Random effects model; I 2 =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 u sed 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 (Engl and), Cochrane Wounds Group, UKDisclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y 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
chlorhexidine

ethanol 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): 39 1/9 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 swab s
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 befo re 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: 14/20 0 (7.0%) Control: 19/200 (9.5%)

P =0.364 Grade 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 S SI Operation Side Bilateral: 8/38 (21%) infected Unilateral: 25/362(7%)
infected Definitions:
Infections: CDC criteria Questionnaire: patient self

reported 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

an timicrobial s, 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

Interventio n: 172/200 (86%) Control: 169/200 (84.5%)
Local Intervention: 28/200 (14%)Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y 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
Mortali ty: 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:

NOT E: In Table 1 they indicate n=250 (62.5%) hernioplasties (prosthetic repair) BUT in the results text they state “Sixty

two percent of patients underwent suture repair [which should be a herniorrhaphy]; prosthetic repair was performed in 33% of patient s [w hich 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 t o 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 postoperativeDisclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y 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
chlorhexidine

alcohol with
that of povidone

iodine 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 w ith 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.; m ean (range): 5 3.3±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%

Histo ry 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 applic ator 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:

Interve ntion: 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 follow

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

and should not be construed to represent any agenc y 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:

I ntervention: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 clean

povidone

- 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
antimicrobial s 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 clippi ng 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%) GynecologicDisclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y 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, alcoh ol 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)

Facto rs 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 =0.001Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y 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)Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y 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
Bloodstrea m Infection Intervention: 11/409 (2.7%) Control: 23/ 440 (5.2%)

- 2.5% (95%CI

- 5.1

- 0.1); pDisclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y 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%C I

- 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 povidone

iodine 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 gende r. 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:
i ntraoperative Agent:
Intervention: 0.5% SSI & Adverse events: (Follow up NR) None of the 50 patients developed any post

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

and should not be construed to represent any agenc y 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 pre

scrub with a
bri stled 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

o nychomycosis, 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 afte r skin

prep. Length of Stay: NR
Readmission: None

Mor tality: 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 skin

preparation 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: NR Intervention1: 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% io dine 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 p rior to
enrollment. All were women. 12 in control, 9 in intervention1, 16 in
intervention2
Other notes: NoneDisclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y 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% io dine
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
infectio n 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 antibacterial

impregnated barriers Mortality: NR
Adverse events: NR Follow up: 10 monthsDisclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y 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 povidone

iodine 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

C lean (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 alcoho l scrub (5 minutes) followed by 4%
chlorhexidine in 70% isopropyl alcohol paint. Timing of Intervention : pre

operatively
Duration of intervention: intraoperative Agents: 4% chlorhexidine in 70% isopropyl alcohol scrub/4% chlorhexidine in 70% isopropyl alc ohol 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 pr e

- 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
Foll ow 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 disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y 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.

Exc lusion 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 povidone

iodine 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, abdominoplas ty, 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
Timin g 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 Superficia l 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 daysDisclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y 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 povidone

iodine soap followed by paint with

aqueous povidone

iodine OR 2) only povidone

iodine paint.] No. Patients: N=234

Patient Characteristics: Demographic data (mean age, obesity, diabetes, p reoperative
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 re present 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 povidone

iodine solution (available iodine 1.0%) only. Timing of Intervention: Preoperative
Duration of intervention

Intraoperative Agent: Aqueous povidone

iodine (1.0%) and povidone

iodine detergent (0.75%) Monitoring interve ntion: NR
Control: n=115
Patients underwent a vigorous 5

- minute scrub using urethane sponges saturated with povidone

iodine detergent (available iodine 0.75%). Detergent
was then absorbed with a blotting towel before painting the operative site with aqueou s povidone

iodine 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 surgi cal 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 disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y determination or policy. 203 Author

Year (Ref ID_ Extractor) Study

Design Qualit

y Score Study Objective Population and Setting Intervention Results Comments

Pancreaticobiliary: 40/23 4 (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: Patien ts 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%)

Interv ention: 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: NRDisclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y determination or policy. 204 Author

Year (Ref ID_ Extractor) Study

Design Qualit

y Score Study Objective Population and Setting Intervention Results Comments

compared with povidone

iodine 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 us e, 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. A llowed 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 povidone

iodine (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: NRDisclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y 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 antimicrobial s (cefazoli n 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 skin

preparation 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%) Intervent ion1: 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 inte rvention: 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) calcanea l 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: NRDisclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y 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

ev aluating 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 w ith 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 character istics: Patient demographics were compared. The following characteristics given represent the whole study. All patients had at least one high

risk factor (the basis of the Intervention1 : n=52
Povidone

- iodine five

- minute scrub with paint
Intervention2: n=50

One

- step iodophor/alcohol

wat er insoluble film
Intervention3 : n=51

one

- step iodophor/alcohol
water insoluble film with Sternal wound Infecti ons: 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 wereDisclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y 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
l arger 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 o f 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 guidel ine 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 visitsDisclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y 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 whi te blood cell count higher than 10,000 or by a temperature higher than

100.5 o F (38.06 o C) 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 povidone

iodine or the
chlorhexidine gluconate
home scrubs plus pre

operative 70% alcohol) in prevention of surgical site

contamination. No. Patients: N=49

Patient Characteristics: Age, gender, weight, co

- morbidities:

NR
Bilat eral 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

opera tion. 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 S tay: 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 : NRDisclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y 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
fo ot 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 frequ ently 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 Characteris tics: 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 Infec tion Definitions: Infected Wounds: if purulent
material drained from the
incision site. Confirm ation 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 disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y 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, film

forming, water

insoluble sk in prep, versus the
tradition al 5

- 10
minute

aqueous iodophor scrub and paint. In both groups, an iodophor

containing
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 u nit 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)
showe rs 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 w as 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 signi ficantly different between groups. Age (average), y: Interven tion: n=30 Skin was prepared with a one

step application of a water

insoluble iodophor

- in

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

and should not be construed to represent any agenc y 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

non

antimicrobial plastic surgical
adhesive drapes. With
the efficacy of a single application of a

water

- insoluble iodophor

- in

alcohol solution
AND a sterile

non

antimicrobial 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.
Timin g 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 t he 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 are a with a sterile, non

antimicrobial 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 adhes ion, particularly at the wound edges. Follow up: NRDisclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y 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 unidi rectional
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. Numb er 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

P rocedures: 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
h ernia
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 iodophor

impregnated drape applied Timing of intervention: perioperatively.
Duration of intervention:

surgery Device/agent: Iodophor

impregnated drape Monitoring intervention: NA Control group: n=487 Patients where no iodophor

impregnated 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. Periopera tive care: NR
Other notes: None
Follow

- up: 3weeks follow upDisclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y 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 povidone

iodine 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

simi lar 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
Obes ity: 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
Setti ng: 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 spi rit Monitoring intervention: NA
Control: n=413 Two applications of povidone

iodine 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, p aying 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 clear

wound 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 significa nt: 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 w ere assessed independently by one member of the nursing staff
and one member of the
medical staff at a “standard” period of 3

- 4 days post

operatively and then at discharge . If patient was discharged before
the 3 rd day was assessed just prior to leaving th e hospital.Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y 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 pati ents 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,
theref ore 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 abnormalitiesDisclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y determination or policy. 21 5 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 abn ormalities 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 disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y 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

Dura tion 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) Er ythema 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: NRDisclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y 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
antimicrobial s (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 3 rd
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 Criter ia: 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 unsati sfactory. 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 wa s 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 Definit ions :
Wound infection: defined in terms of the discharge of pus from the wound. Usually a small amount (e.g., the so

called stitch abscess), but
sometimes a wound abscess developed which required evacuation by removal of a suture and spreading of the

wou nd 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
accept ed by itself as an
indication of infection. Perioperative care: NR
Other notes: None
Follow

- up: at least 4 weeks.Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y 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
post

procedure
infections. Number of patients: N=293

Patient Characteristic s: 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 pr otocol: n=131 Surgical sites were prepared with commonly used surgical skin preparations such as povidone

iodine 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 inte rvention: 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 ma y 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
postopDisclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y 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

cyan o acrylate, isopropyl alcohol, iodine or iodine

Control group:

ITT: n= 147
Per Protocol: n=138 Surgical sites were prepared with commonly used surgical skin preparations such as povidone

iodine 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 an d not specified in the study protocol 35% relative ri sk
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 patientsDisclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y 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 s kin
conditions around the surgical incision site,
antimicrobial

impregnated incise drapes used during the operation, chemotherapy, immunosuppressive therapy or steroid therapy, use of
antimicrobial s for an active infection, HIV
infection with CD4 count

<35 0mm 3 , therapeutic radiation or renal dialysis, morbid obesity (BMI>37kg/m 2 ); 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 t o 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%)

Ost eomyelitis Intervention: 1 (0.7%)Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y 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%)

C ontrol: 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 TobaccoDisclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y 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

Inter vention: 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 re

exploration 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%)
Sudd en 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 disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y 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: hemorrhagi c 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 disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y 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

pro cedure 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 con duit 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 alcohol ic 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

s ealant 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

incisi on 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 incis ion 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

i nflammation 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 w ithout 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 arrangedDisclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y 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 i f 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 subcutaneou s 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 32 o to 34 o C. 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.

Co ntrol: 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 follow

up 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 op erative 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 upDisclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y 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/m 2 ) 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 di sease. 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 cyanoacrylate

based microbial sealant. The sealant was allowed to dry before the application of surgical drapes.

Timing of intervention: Pre intra, and
postoper atively
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 me asures: Surgeons were allowed to perform the open inguinal hernia repair based on their personal preference with respect to hair clipping, perioperative antimicrobial s, surgical techniques and use of mesh Preoperative data: Based on Total population N=17 6 because data missing from 1

intervention
Antimicrobial shower: infection with MRSA
Given the low number of

ev ents 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 re ported 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

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

and should not be construed to represent any agenc y 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

c omplete 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 antimicrobial s. 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

Intervent ion: 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: 0Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y 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
ke l oid formation; currently receiving high

dose steroid or immunosuppressive
th erapy; 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)
antimicrobial s within 20 days prior to the day of
surgery; pregnant or
nursin g; or participation in any other study of an investigational drug or
device within 2 week prior to the current procedure. Incisional bleeding

Interv ention: 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 CommentsDisclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y 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
Af ter 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 interventi on: 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 perin eum 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

- t high 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 umbilica l cord, patient received 1g of cephazolin SSI:

Drape: 34/305 (11.1%) No Drap e: 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 disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y 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
f racture 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 a t 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: NRDisclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y 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.
Excl usion Criteria: NR



### Q 9 . 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 povidone

iodine 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 2 000cc of normal saline to remove povidone

- iodine
solution. Timing of intervention: intraoperative
Duration of intervention: 3min Device/agent: 0.53% povidone

iodine 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:

N R 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: belo w lumbosacral fascia & all deep infections were confirmed by lab parameters including the erythrocyte sedimentation rate (ESR) and level of C

reactive protein (CRP) and a positive culture of biopsy. Perioperative care: NA
Other notes: none Follow

- up: eve ry 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 disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y 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
poster olateral 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 salin e (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)Disclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y 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
und ergoing 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.

S kin 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 event s: 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. intra

abdominal 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 intra

Intervention group: n=37 Irrigation of the intraperitoneal area was perf ormed 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 performe d 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
Oth er notes: None
Follow

- up: 7daysDisclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y determination or policy. 234 Author

Year (Data Extractor) Risk of

Bias

Score Study Objective Population and Setting Intervention Results Comments

surgical procedures
where ther e was likely to be
bacterial

contamination
of the peritoneal cavity) abdominal surgery

involving entry into the peritoneal cavity whe re the surgery was
classified as contaminated or dirty (esophageal, gastric, small intestinal, colonic, hepatic, pancreatico

biliary.
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 intraperiton eal 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 pr ior to skin closure
with 1000ml of saline. Standard preventive measures: AMP: patients received peri

- operative
antimicrobial s 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 toxicityDisclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y 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
Povidone

Iodine 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 laparotom y 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 begu n 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:
Proced ures: Clean (Inguinal hernia repair, cholecystectomy, laparotomy, hiatal hernia repair, proximal gastric vagotomy, ventral hernia, and other), clean contaminated (upper Intervention group: n=86
After fasci al 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 monthDisclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y 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:

opera tions 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 clean

contaminated 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 colorec tal surgeries. P

- I: 1/6 (16.6%) Saline: 1/6 (16.6%) p=NSDisclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y 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 povidone

iodine 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.

Exc lusion 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

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

and should not be construed to represent any agenc y 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 povidone

iodine 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
Setti ng: 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 closu re, 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.
Ti ming 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 b y 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 disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y 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



### Q 10 . How safe and effective is repeat application of an antiseptic skin preparation agent to the surgical site immediately prio r to closing the surgical incision?

Author

Year (Data Extractor) Risk of

Bias

Score Stud y Objective Population and Setting Intervention Results Comments

Harihara

2006 107
(ES) RCT

1, To investigate
whether
incisional topical application of
Povidone

iodine (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 (PVP

I) 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
Colorec tal 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: NRDisclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y determination or policy. 240 Author

Year (Data Extractor) Risk of

Bias

Score Stud y Objective Population and Setting Intervention Results Comments

Gastric
Intervention: 18:5

Cont rol: 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
colo rectal )
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 incis ion 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

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

and should not be construed to represent any agenc y determination or policy. 241 Author

Year (Data Extractor) Risk of

Bias

Score Stud y 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
inf ection 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 statisticalDisclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y determination or policy. 242 Author

Year (Data Extractor) Risk of

Bias

Score Stud y 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
Cult ure Positive: 4/7 (57.1%) Culture Negative: 6/53 (11.3%)

P=0.0115

Reoperations: NR Length of stay: NR Mortality: NR
Adverse events: NRDisclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y determination or policy. 243 

## RISK OF BIAS ASSESSMENTS OF STUDIES Q 8

- 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 Indiv idual

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
in terest 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 double

blind 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      LowDisclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y determination or policy. 244 Author Year (RefID) KQ Described

as randomized Randomization

appropriately performed Described

as double

blind 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          LowDisclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y determination or policy. 245 

# SECTION 3: E VALUATION 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 d escribed 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 tabl e, 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 assig ned patients 9) Attrition appropriately analyzed (e.g. intention to treat analysis) 10) Funding source(s) disclosed and no obvious conflict of interestDisclaimer. This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminate d by the Centers for Disease Control and Prevention

and should not be construed to represent any agenc y 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) F unding 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 Quali ty 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 Cen ters for Disease Control and Prevention and should not

be construed to represent any ag ency determ ination or policy. 247 

# SECTION 4 : EVIDENCE TABLE EXTRACTION TEMPLATES

1

. SYSTEMATIC REVIEW (S R) EXTRACTION TEMPLA TE

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 CONTROLLE D 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

- upDisclaimer: This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminated by the Cen ters for Disease Control and Prevention and should not

be construed to represent any ag ency determ ination or policy. 248 

# 3. OTHER CONTROLLED STU DIES 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 Cen ters for Disease Control and Prevention and should not

be construed to represent any ag ency determ ination or policy. 249 

# SECTION 5 : STUDY TYPE DETERMINATION ALGORITHM

Adapted from: Hartling et. al 2010Disclaimer: This document is a draft. The findings and conclusions in this draft guideline have not been formally disseminated by the Cen ters for Disease Control and Prevention and should not

be construed to represent any ag ency determ ination or policy. 250 

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