Clinical trial NCT02374853
Conditions: INFECTION
Sponsor: University of Alberta
Start date: 2015-03-01; Completion date: 2019-04-01
Enrollment: 1037 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this research is to determine if using the antibiotic vancomycin as a preventative topical (on the surface of the skin) treatment during open-heart surgery will reduce the risk of developing a sternal wound infection.

Detailed description:
During open-heart surgery, an incision is made along the chest and the sternum (breastbone) is divided. The sternum is held open throughout the surgery so that the doctors can reach the heart. Sternal wound infection is an uncommon but serious complication of cardiac surgery that occurs when an infection develops at this site of entry. Sternal wound infections are associated with increased hospital stays, subsequent surgical procedures, and higher mortality rates.

The purpose of this research is to determine if using the antibiotic vancomycin as a preventative topical (on the surface of the skin) treatment during open-heart surgery will reduce the risk of developing a sternal wound infection. The results of this study could provide important information to guide new standards of practice in cardiac surgery. The ultimate goal of this research project is to improve patient care by reducing the number of sternal wound infections at our hospital.

Arms: arm 1: During open heart surgery, patients will have a 4 x 8 inch piece of sterile gauze covering each side of the divided sternum. The gauze will be soaked in the following solution: 5 g vancomycin dissolved in 50 mL sterile water arm 2: During open heart surgery, patients will have a 4 x 8 inch piece of sterile gauze covering each side of the divided sternum. The gauze will be soaked in 50 mL sterile water. No Vancomycin
Interventions: intervention 1: Vancomycin intervention 2: No Vancomycin
Intervention descriptions: intervention 1: Topical prophylactic antibiotic intervention 2: Placebo: Sterile water. No Vancomycin.

Protocol documents:
Prot_SAP_000.pdf: 
 
 
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TOPICAL USE OF VANCOMYCIN IN REDUCING STERNAL WOUND 
INFECTION IN CARDIAC SURGERY 
 
 
 
Protocol 
 
 
 
Principal Investigator: Dr. John C. Mullen 
 
Sponsored By University of Alberta 
 
 
 
Protocol #: SWI-01-14 
 


 
 
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GENERAL INFORMATION 
 
 
PRINCIPAL INVESTIGATOR: 
Dr. John C. Mullen 
C/O Kayla-Marie Smith 
2D2.18 WMC, 8440 112 Street 
Edmonton, AB, Canada 
T6G 2B7 
 
Tel: (780) 966-8787 
Email: akhani@ualberta.ca  
 
 
 
SPONSOR: 
The Governors of the University of Alberta 
2-51 South Academic Building (SAB), University of Alberta 
Edmonton, AB, Canada 
T6G 2G7 
 
 
Dr. Lorne Babiuk 
Vice President (Research) 
Tel: 780-492-5353 / Fax: 780-492-3189 
Email: lorne.babiuk@ualberta.ca 
 
 
 
CLINICAL CENTRE: 
University of Alberta Hospital / Mazankowski Alberta Heart Institute 
 
 
 
PROTOCOL DEVELOPMENT COMMITTEE: 
Abbas Khani-Hanjani, MD; Emily J Kuurstra, BSc 
 


 
 
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TABLE OF CONTENTS 
 
TABLE OF CONTENTS 
……………………………………………………………………………………………….………… 
3 
STUDY SUMMARY 
………………………………………………….……………………………………………………...….. 
4 
DATA COLLECTION SUMMARY 
.………………………………………………………………………………….……… 
5 
ABREVIATIONS & ACRONYMS 
…………………………………………………………………………………….……… 
6 
BACKGROUND 
……………………………………….………………………………………………………………….………. 
7 
OBJECTIVES 
………………………………………………………………………………………………..………………..……. 
7 
TRIAL DESIGN 
………………………………………………………………………………………………………….…………. 
7 
TREATMENT ASSIGNMENT 
………………………………………………………………………………………………… 
7 
RANDOMIZATION 
……………………………………………………………………………………………………….……… 
8 
MASKING 
…………………………………………………………………………………………………………………………… 
8 
INVERVENTIONAL AGENT 
…………………………………………….…………………………………………..……….. 
8 
ELIGIBILITY CRITERIA 
…………………………………………………………………………………………………….……. 
9 
DATA COLLECTION 
……………………………………………………………………………..……………………………… 
9 
ENDPOINTS 
…………………………………………………………………….………………………………………..….……. 
10 
ADVERSE EVENTS 
………………………………………………….…………………………………………………………… 
11 
DATA MANAGEMENT 
………………………………………………………………………………………………………… 
11 
STATISTICAL ANALYSIS 
PLAN.……………………………………………………………..……………………….……… 
11 
TRIAL CONDUCT 
………………………………………………………………………………………………………………… 
12 
REFERENCES 
………………………………………………….….……………………………..………………………………… 
13 
APPENDIX I: CARDIAC SURGERY DATA COLLECTION FORM 
……………………….…………………..…… 
14 


 
 
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APPENDIX II: SURGICAL SITE INFECTION SURVEILLANCE FORM 
…………………………………….…… 
19 
APPENDIX III: CASE REPORT FORMS 
…………………………………………………..……………………….……… 
22 
 
 
 
 
 


 
 
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STUDY SUMMARY 
 
Title 
Topical Use of vancomycin in Reducing Sternal Wound Infection in Cardiac 
Surgery 
Objective 
To determine if using topical vancomycin as a prophylactic treatment during 
open heart surgery will reduce the incidence of sternal wound infection 
(SWI).   
Methodology 
Prospective, double-blind, randomized (1:1) controlled trial. 
Rx Arms 
During open heart surgery, patients will have a 4x8 inch piece of sterile 
gauze covering each side of the divided sternum.  The gauze will be soaked 
in the following solutions: 
          Group 1: 5 g vancomycin dissolved in 50 mL sterile water for injection 
    Group 2: 50 mL sterile  water for injection 
Number of Subjects 
A total of 1,552 patients will be randomized to either vancomycin or no 
vancomycin.  This will provide an 80% power to detect a 50% reduction in 
infection rates (7% versus 3.5%). 
1° Endpoints 
The incidence of SWI (including superficial incisional, deep incisional, and 
organ/space surgical site infections) at 3 months postoperative. 
2° Endpoints 
• Incidence of SWI at 1 year postoperative 
• Duration of index hospitalization and subsequent readmissions due to 
SWI 
• Use of prophylactic antibiotics  
• Cost analysis  
• Adverse events 
Duration 
Accrual is expected to take 3 years.   All patients will be followed for one 
year postoperatively.  
Inclusion Criteria 
• Able to sign Informed Consent and Release of Medical Information Form 
• Age ≥ 18 years 
• Undergoing cardiac surgery with complete sternotomy (including re-
operations)  
Exclusion Criteria 
• Evidence of active infection (any culture positive or blood positive 
infection) 
• Undergoing organ transplantation 
• Patients with known hypersensitivity to vancomycin 
• Pregnant or nursing women 
• Mental impairment or other conditions that may not allow participant to 
understand the nature, significance, and scope of study 
 
 
 
 


 
 
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DATA COLLECTION SUMMARY 
 
ASSESSMENT 
BASELINE 
PROCEDURE 
PRE-DISCHARGE 
EVENT DRIVEN 
Informed Consent 
X 
 
 
 
Eligibility and Enrollment 
X 
 
 
 
Baseline Characteristics 
X 
 
 
 
Index Surgery 
 
X 
 
 
Index Hospital Discharge 
 
 
X 
 
Postoperative Laboratory Results 
 
 
X 
X 
APPROACH Data 
X 
X 
X 
X 
ProvServ Data 
 
 
X 
X 
 
 
 
 
 
 
 
 


 
 
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ABBREVIATIONS & ACRONYMS 
 
SWI 
Sternal wound infection 
DM 
Diabetes mellitus 
OR 
Operating room 
EPICORE 
Epidemiology Coordinating and Research 
DIN 
Drug Identification Number 
APPROACH 
Alberta provincial project for outcome assessment in coronary heart disease 
RedCap 
Research electronic data capture 
CR 
Creatinine 
GFR 
Glomerular filtration rate 
QMCR 
Quality management in clinical research 
HREB 
Health research ethics board 
HGB 
Hemoglobin 
HCT 
Hematocrit 
PLT 
Platelet count 
WBC 
White blood cell count 
NEUT 
Neutrophil count 
LYMPH 
Lymphocyte count 
MONO 
Monocyte count 
EOS 
Eosinophil count 
BASO 
Basophil count 
Na 
Sodium 
K 
Potassium 
 
 
 
 


 
 
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BACKGROUND 
Sternal wound infection (SWI) is an uncommon yet serious risk associated with open heart surgery.  
Both superficial and deep SWI are associated with significant comorbidities, longer hospital stay and 
costs.  Deep SWI affects 1-3% of patients postoperatively with a mortality rate of 20-30% for patients 
who develop mediastinitis [1-3].  A number of risk factors – such as diabetes (DM), obesity, and complex 
cardiovascular operations requiring longer surgical time – have been associated with the development 
of SWI [1].  Given that these risk factors are on the rise in today’s cardiovascular surgical practices, 
alternative strategies should be considered to reduce and/or avoid the complication of SWI. Topical use 
of antibiotics has been shown to be effective in reducing at least Deep SWI both in small randomized 
studies and Meta analyses [3-4]. The most common bacterial culprits in SWI are staphylococcus species 
that are mostly sensitive to Vancomycin. However, systemic use of these antibiotics is associated with 
drug side effects such as nephrotoxicity and therefore their use is limited in patients with renal failure or 
insufficiency, which make up a significant number of patients undergoing open heart surgery. Studies 
have shown that the use of topical Vancomycin could be both safe and effective in reducing deep SWI 
even in patients with renal failure and insufficiency [5, 6]. Vancomycin is currently being used topically in 
a number of American centres (such as Cleveland Clinic and Boston Medical Center [5]).  However, the 
topical use of vancomycin is considered off-label use of this drug in Canada and is not generally being 
used. The current overall rate of superficial and deep SWI in our institute is around 7%, the proposed 
study will attempt to assess and reduce the rate of SWI in patient undergoing open heart surgery. 
 
 
OBJECTIVES  
The primary objective of this clinical trial is to determine if using topical vancomycin as a prophylactic 
treatment during open heart surgery will reduce the incidence of SWI.   
 
 
TRIAL DESIGN 
This is a double-blind, randomized clinical trial.  The study will be conducted at the University of Alberta 
Hospital and 1,552 patients will be randomized.  All patients will be followed for one year 
postoperatively. 
 
 
TREATMENT ASSIGNMENT 
During open heart surgery, patients will have one piece of sterile gauze covering each side of the divided 
sternum.  The investigators intend to use Derma Sciences Inc. Dupaque X-Ray Detectable 4 x 8 inch 
sponges for the purpose of this study.  The gauze will be soaked in one of the following solutions 
(depending on the randomized treatment assignment) until the solution is absorbed (approximately 1-2 
minutes): 
           
Group 1:  5 g vancomycin dissolved in 50 mL sterile water for injection 
Group 2:  50 mL sterile water for injection 
 
The soaked gauzes will be applied and remain on the divided sternum once hemostasis has been 
achieved.  The gauzes will be removed in the operating room (OR) at the end of the surgical 
procedure(s), just prior to chest closure. 
 
 


 
 
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RANDOMIZATION 
Patients will be randomized in a 1:1 fashion.  By this arrangement, 50% of the patients will receive 
topical vancomycin (Group 1) and 50% will not receive topical vancomycin (Group 2) during open heart 
surgery. 
 
 
MASKING 
This is a double-blind, sham procedure controlled trial.  In order to maintain blinding of the 
investigators, the study coordinators, and the patients, Epidemiology Coordinating and Research 
(EPICORE) Centre will create a confidential randomization key.  This key will be provided to the site’s 
Research Pharmacy Office in order to guide the preparation of masked syringes containing either 5 g 
vancomycin dissolved in 50 mL sterile water (Group 1) or 50 mL sterile water (Group 2).  The syringes 
will be prepared in small batches and labeled with expiration dates based on the chemical stability (96 
hours) of vancomycin in sterile water for injection at a concentration of 100 mg/mL [7].   The study 
syringes will be stored in a refrigerator in the OR and therefore readily available for use. 
 
 
INTERVENTIONAL AGENT 
The interventional agent to be used in this clinical trial is Prvancomycin hydrochloride for injection, USP 
(Pharmaceutical Partners of Canada Inc, Richmond Hill, ON).  The product’s Drug Identification Number 
(DIN) is 02139383. 
 
 
ADVERSE REACTIONS 
There have been rare reports of renal failure in patients treated intravenously with vancomycin, 
particularly when given large doses [7].  Most of these cases involved patients who had pre-existing 
kidney dysfunction or patients who received concomitant aminoglycosides. 
 
The development of reversible neutropenia has been reported; usually beginning at least a week after 
the onset of treatment with vancomycin or after a total dose of more than 25 g has been administered 
[7]. 
 
Approximately two dozen patients have reported hearing loss associated with the use of vancomycin 
[7].   In most of these cases, patients also had kidney dysfunction, pre-existing hearing loss, or 
concomitant treatment with an ototoxic drug. 
 
DOSE RATIONALE 
Topical use of 5 g of vancomycin, in paste form, has been shown to reduce the rate of deep SWI without 
any significant adverse effect on the patient undergoing open heart surgery [5]. However there is no 
double blinded randomized controlled study to confirm the effectiveness of topical vancomycin in 
reducing SWI.  The current randomized controlled trial will use 5 g of solubilized vancomycin, in 50 mL of 
sterile water for injection, for a topical application on sternal wound to evaluate the rate of total sternal 
wound (superficial and deep) infection.  
 


 
 
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Note: The investigators intend to use Sterile Water for Injection USP (Baxter Corporation, Mississauga, 
ON) based on availability (DIN: 02014882). 
 
ELIGIBILITY CRITERIA 
 
INCLUSION CRITERIA 
• 
Able to sign Informed Consent and Release of Medical Information Form 
• 
Age ≥ 18 years 
• 
Undergoing cardiac surgery with complete sternotomy (including re-operations)  
 
 
EXCLUSION CRITERIA 
• 
Evidence of active infection (any culture positive or blood positive infection) 
• 
Undergoing organ transplantation 
• 
Patients with known hypersensitivity to vancomycin 
• 
Pregnant or nursing women 
• 
Mental impairment or other conditions that may not allow participant to understand the nature, 
significance, and scope of study 
 
 
DATA COLLECTION 
 
The majority of data collected in this trial will be obtained from pre-existing hospital databases.  The 
Alberta Provincial Project for Outcome Assessment in Coronary Heart Disease (APPROACH) database will 
be the source of information such as the patients’ medical history, index procedure, and in-hospital 
postoperative complications.  The Cardiac Surgery Data Collection Form (APPENDIX I) contains a 
complete list of data elements that will be obtained from the APPROACH database.   
 
Alberta Health Services’ ProvServ database maintains record of all patients who are treated at the 
clinical site for SWI, within one year of surgery.  This database will provide follow-up information 
regarding the incidence of SWI in both study groups.  A complete list of data elements that will be 
obtained from the ProvServ database can be found on the Surgical Site Infection Surveillance Form 
(APPENDIX II). 
 
All data collected using the Case Report Forms (APPENDIX III) will be entered into the Research 
Electronic Data Capture (REDCap) system created by EPICORE Centre. 
 
CONSENT 
Prior to protocol-defined data collection, the study personnel will meet with the potential study 
participant to thoroughly discuss the nature of the clinical trial.  All risks and benefits of the study will be 
explained; and all questions will be answered to the satisfaction of the participant prior to signing the 
informed consent form.   
 
ELIGIBILITY AND ENROLLMENT 
The inclusion and exclusion criteria will be document by the study personnel prior to randomization.  All 
consented patients will be given a unique 5-digit identification code which will be used throughout the 
course of the study. 


 
 
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BASELINE CHARACTERISTICS FORM 
This form captures the necessary patient identifiers that will be used to match and pull data from the 
hospital’s databases.  Information pertaining to the patient’s baseline functionality, immune system 
functionality, and laboratory results will also be collected.  The study personnel will obtain laboratory 
results from routine preoperative blood work, specifically selecting the assessment that was performed 
closed to the patient’s index surgery. 
 
INDEX SURGERY FORM 
The identification number of the used masked syringes will be recorded, as well as any adverse reactions 
to the study product observed within 24 hours. 
 
INDEX HOSPITAL DISCHARGE FORM 
This form captures whether the patient is discharged on antibiotic medications. 
 
POSTOP LABORATORY RESULTS FORM 
The study personnel will review the standard of care postoperative laboratory results listed on this form 
and record the last value obtained for each parameter, prior to index hospital discharge.  If the 
creatinine (CR), or Glomerular filtration rate (GFR) is abnormal at this time, the patient’s laboratory 
results will be monitored post-hospital discharge.  The study personnel will record all protocol-defined 
laboratory results until the patient has reached their baseline value (± 10%) or normal range; or until 
they have reached one year postoperative (whichever comes first).   
 
 
ENDPOINTS 
 
PRIMARY ENDPOINTS 
 
Incidence of SWI 
The primary endpoint of this trial is the incidence of SWI at 3 months postoperative.  This includes 
superficial incisional, deep incisional, and organ/space surgical site infections as defined in Appendix II.  
The data will be obtained from the ProvServ database. 
 
SECONDARY ENDPOINTS 
 
Incidence of SWI 
The incidence of SWI at 1 year postoperative will also be determined. 
 
Duration of index hospitalization and subsequent re-admissions due to SWI 
The length of hospital stay from index surgery to hospital discharge will be recorded for all patients.  The 
duration of subsequent re-admissions due to SWI will also be documented. 
 
Use of prophylactic antibiotics 
The use of prophylactic antibiotics at index hospital discharge will be recorded for all patients.  The 
ProvServ database will also provide information regarding the use of prophylactic antibiotics for those 
patients returning to hospital with signs of infection.  


 
 
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Cost analysis for SWI treatment 
The study personnel will obtain hospital costing data for the various assessments and procedures 
involved in the treatment of SWI.  This will allow comparisons to be made regarding the cost 
effectiveness of using topical vancomycin as a prophylactic treatment.   
 
Adverse events  
The study personnel will document and compare the occurrence of adverse events in each treatment 
group (see the Adverse Events section for further details).   
 
 
ADVERSE EVENTS 
 
RENAL INSUFFICIENCY/FAILURE 
Defined as significant increases in creatinine or decreases in glomerular filtration rate between baseline 
and pre-discharge laboratory results. 
 
NEUTROPENIA 
Abnormally low postoperative neutrophil count. 
 
HEARING LOSS 
New onset hearing loss or worsening of a pre-existing condition. 
 
ALLERGIC REACTIONS TO VANCOMYCIN 
Abnormal redness or sensitivity of skin at the site of vancomycin application.  Hypotension following the 
administration of vancomycin. 
 
GENERAL 
Further postoperative complications/adverse events will be obtained from the APPROACH database.  
Please refer to APPENDIX I for a complete list. 
 
 
DATA MANAGEMENT 
All study data actively collected by the study personnel (APPENDIX III) will be entered in the secure web-
based REDCap system.  Study personnel requiring access will have their own login and password.  Data 
obtained from the hospital databases (APPENDICES II-III) will be collected and stored according to the 
security measures currently implemented by the custodians of the databases. 
 
On-site monitoring will be provided by the University of Alberta’s Quality Management in Clinical 
Research (QMCR), as per established guidelines. 
 
 
STATISTICAL ANALYSIS PLAN 
The statistical plan and analysis for this study is being provided by EPICORE Centre.   
 
ANALYSIS OF PRIMARY END POINT: 


 
 
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The primary analysis will compare the proportions of patients having sternal wound infection between 
the two treatment groups using chi-squared test. Analyses will be performed according to the intention-
to-treat principle. Descriptive statistics including frequency distributions, percentages, means and 
standard deviations will be presented for the baseline variables. The median and the IQR (Inter Quartile 
Range) will be used to represent variables with skewed distributions. The baseline variables will be 
compared between the treatment groups using chi-squared test, t-test or Wilcoxon Mann-Whitney test, 
as appropriate. If necessary, a multi-variable analysis will be performed using logistic regression to control 
potential confounding effect in the analysis stage. All the statistical tests will be two-sided. A p-value of 
<0.05 will be considered statistically significant.  
 
ANALYSIS OF SECONDARY END POINTS: 
Secondary end points will be evaluated at the end of the study. Duration of index hospitalization between 
the treatment groups will be compared using survival analysis. The log rank test will be used. The total 
and the mean number of readmissions between the two groups will be compared by t-test or Wilcoxon 
Mann-Whitney test, as appropriate. A chi-squared test will be used to compare the use of prophylactic 
antibiotics. Cost analysis will be performed by comparing means or medians between the groups using t-
test or Wilcoxon Mann-Whitney test, as appropriate. If necessary, multi-variable linear or logistic 
regression will be performed for the secondary end points, as appropriate. All the statistical tests will be 
two-sided. A p-value of <0.05 will be considered statistically significant.  
 
ANALYSIS OF ADVERSE EVENTS: 
Adverse events will be reported by frequency tables, percentages, means, standard deviations, medians 
or IQRs as appropriate at the interim and the final analysis. Proportions of adverse events between the 
groups will be compared by chi-squared test. Means or medians will be compared by t-test or Wilcoxon 
Mann-Whitney test, as appropriate. Count data will be compared by Poisson regression. 
 
INTERIM ANALYSIS: 
One interim analysis will be performed in a half way of the trial (after 776 patients will be followed). 
Interim analysis will be performed on the primary end point and the adverse events using a two-sided 
significance test with O'Brien-Fleming type spending function and a type I error rate of 5%. 
 
 
TRIAL CONDUCT 
This study will be conducted in compliance with the protocol approved by the University of Alberta 
Health Research Ethics Board (HREB), and according to Good Clinical Practice standards.  No deviation 
from the protocol will be implemented without the prior review and approval of the HREB except where 
it may be necessary to eliminate an immediate hazard to a research subject.  In such case, the deviation 
will be reported to the HREB as soon as possible. 
 


 
 
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REFERENCES 
 
[1] 
Borger MA, Rao V, Weisel RD, et al. Deep sternal wound infection: risk factors and outcomes.  
Ann Thorac Surg 1998;65:1050-6. 
 
[2] 
Mauermann WJ, Sampathkurmar P, Thompson RL.  Sternal wound infections. Best Pract Res Clin 
Anaesthesiol 2008;22:423-36. 
 
[3] 
Friberg O, Svedjeholm R, Söderquist B, Granfeldt H, Vikerfors T, Källman J. Local gentamicin 
reduces sternal wound infections after cardiac surgery: a randomized controlled trial. Ann 
Thorac Surg 2005;79:153-61. 
 
[4] 
Mavros MN, Mitsikostas PK, Alexiou VG, Peppas G, Falagas ME. Gentamicin collagen sponges for 
the prevention of sternal wound infection: A meta-analysis of randomized controlled trials. J 
Thorac Cardiovasc Surg 2012;144:1235-40. 
 
[5] 
Lazar HL, Barlam T, Cabral H. The effect of topical vancomycin applied to sternotomy incisions 
on postoperative serum vancomycin levels. J Card Surg 2011;26:461-5. 
 
[6] 
Vander Salm TJ, Okike ON, Pasque MK, Pezzella AT, Lew R, Traina V, Mathieu R.  Reduction of 
Sternal Infection by Application of Topical Vancomycin.  Thorac Cardiovasc Surg 1989;98:618-
22. 
 
[7] 
Pharmaceutical Partners of Canada Inc., Product Monograph, PrVANCOMYCIN HYDROCHLORIDE 
FOR INJECTION, USP. Control # 144773, March 7, 2011. 
 
 
 
 
 
 


 
 
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APPENDIX I: CARDIAC SURGERY DATA COLLECTION FORM 
 
 


 
 
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APPENDIX II: SURGICAL SITE INFECTION SURVEILLANCE FORM 
 
 
 


 
 
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Surgical Site Infection Surveillance Form 
Revised:  May 2014 for UAH & Stollery 
DEMOGRAPHIC DATA 
Name:   
        Last name                                            First Name                            Middle Name     
Date of Birth:  
(yyyy/mmm/dd)_________/___________/________ 
Gender:  
 M  
 F  
 Unk 
AB PHN/ULI: 
Hospital ID #                                                 
 Unk 
CHEC # (if applicable)  
SURGICAL INFORMATION 
Procedure Type: 
 Provincial-Total Hip Replacement (TH)  
 Provincial-Total Knee Replacement (TK) 
 Other: (see reverse) 
Bilateral Procedure:   
 Y    
 N    
 
  Right 
   Left 
Donor Site: 
Procedure Date:   
(yyyy/mmm/dd)       _________/___________/________ 
Incision Start Time: 
Incision Closure Time & Date: 
Classification: 
 Clean    
 Clean-Contaminated   
                          
 Contaminated    
 Dirty-Infected 
ASA Score: 
 1    
 2    
 3   
 4   
 5 
Procedure Zone: 
Procedure Facility: 
Name of Surgeon: 
Antibiotic Prophylaxis 
 Acceptable    
 Unacceptable 
 Unable to collect   
 None Given 
 Cefazolin (ancef)       
 1g              
 2g   
 Ciprofloxacin              
 400 mg   
 Clindamycin               
 600mg       
 900mg               
 Flagyl                         
 500 mg   
 Gentamicin                
 7 mg/kg   
 Vancomycin               
 1g              
 1.5g             
 Other (specify):                      
Antibiotic Date & Time: 
Antibiotic Prophylaxis Re-dose 
 Acceptable    
 Unacceptable     
 Unable to collect   
 None Given  
 Cefazolin (ancef)       
 1g              
 2g   
 Ciprofloxacin              
 400 mg   
 Clindamycin               
 600mg       
 900mg               
 Flagyl                         
 500 mg   
 Gentamicin                
 7 mg/kg   
 Vancomycin               
 1g              
 1.5g             
 Other (specify):                      
Antibiotic Date & Time: 
INFECTION INFORMATION 
Surgical Site Infection Type: 
 Superficial Incisional (up to 30 days only) 
 Deep Incisional 
 Organ-Space 
Infection Onset Date:  
 
_________/___________/_______ 
        yyyy/         mmm     / dd 
Culture Result: 
 Positive    
 Negative    
 None taken 
 
Culture Date:(yyyy/mmm/dd) _________/___________/______ 
 
Culture Type (see reverse): ____________________________ 
Organism isolated (if applicable):                   
 Coagulase negative Staphylococcus spp   
 Enterococcus spp (specify): 
 Staphylococcus aureus                                
 Gram negative organism (specify):             
 Other:                                             
 
Clinical signs and symptoms of infection (check all that apply): 
 Aseptically-obtained culture taken (fluid or tissue) 
 Purulent drainage 
 Pain and/or tenderness 
 Localized swelling, redness and/or heat 
 Diagnosis of superficial SSI by surgeon, attending 
physician or other designee 
Additional Infection Comments: 
 Dehiscence 
 Fever (>38°C) 
 Incision deliberately opened by surgeon 
 Abscess or other evidence of infection (on direct exam, during reoperation, by 
histopathologic or radiologic examination) 
 
CURRENT LOCATION INFORMATION 
Re-admission Date:  
(if applicable) (yyyy/mmm/dd)  ______/________/_____ 
Current Encounter Facility: 
Case Identification (check all that apply): 
 Microbiology Report 
 Emergency Room Visit 
 Readmission to Hospital 
 IV Antibiotic Therapy Clinic 
 Revision or other Surgical Procedure 
 At Orthopaedic Surgeon Office  
 Observation of patient/incision/chart review 
 Other (specify):  
Current Encounter Zone: 
Re-operation date (if applicable): 
  
                                                       ______/________/______ 
                                                          yyyy/  mmm     / dd 
ICP Name: 
Name 
 
 
AB PHN/ULI  
 
Hospital ID# 
 


 
 
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QUICK GUIDE FOR CDC/NHSN SURVEILLANCE DEFINTIONS (Feb. 2014) 
1. 
Superficial incisional surgical site infection:  
Infection occurs within 30 days after the operative procedure AND 
Involves only skin and subcutaneous tissue of the incision AND 
Patient has at least 1 of the following:  
a. Purulent drainage from the superficial incision.  
b. Organisms isolated from an aseptically obtained culture of fluid or tissue from the superficial incision.  
c. Superficial incision that is deliberately opened by a surgeon, attending physician or other designee and is culture positive or not cultured 
and patient has at least one of the following signs or symptoms: pain or tenderness; localized swelling; redness; or heat. A culture negative 
finding does not meet this criterion.  
d. Diagnosis of a superficial incisional SSI by the surgeon or attending physician or other designee 
 
2. 
Deep incisional surgical site infection:  
Infection occurs within 1 year if implant is in place and the infection appears to be related to the operative procedure AND 
Involves deep soft tissues (eg, fascia and muscle layers) of the incision AND  
Patient has at least 1 of the following: 
a. Purulent drainage from the deep incision. 
b. A deep incision that spontaneously dehisces or is deliberately opened by a surgeon, attending physician or other designee and is culture-
positive or not cultured and the patient has at least 1 of the following signs or symptoms: fever (>380c); localized pain or tenderness. A culture-
negative finding does not meet this criterion. 
c. An abscess or other evidence of infection involving the deep incision is found on direct examination, during reoperation, or by histopathologic or 
radiologic examination. 
 
3. 
Organ/space surgical site infection:  
Infection occurs within 1 year if implant is in place and the infection appears to be related to the operative procedure AND 
Infection involves any part of the body, excluding the skin incision, fascia, or muscle layers, that is opened or manipulated during the operative procedure 
AND 
Patient has at least 1 of the following:  
a. Purulent drainage from a drain that is placed through a stab wound into 
the organ/space. 
b. Organisms isolated from an aseptically obtained culture of fluid or tissue 
in the organ/space.  
c. An abscess or other evidence of infection involving the organ/space that is 
found on direct examination, during reoperation, or by histopathologic or 
radiologic examination and meets at least one criterion for a specific 
organ/space infection site listed in NHSN Table 4 here 
http://www.cdc.gov/nhsn/PDFs/pscManual/17pscNosInfDef_current.pdf  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Culture Types: 
Fluid - aspirate 
Deep wound 
Tissue 
Superficial wound swab 
Other 
Other Procedure Types: 
Misc. Surgery:      
• 
Appendix 
Surgery 
• 
Biliary Liver 
Pancreas 
• 
Breast Surgery 
• 
Colon Surgery 
• 
Exploratory Abd 
Surgery 
• 
Gallbladder 
Surgery 
• 
Gastric Surgery 
• 
Herniorrhaphy 
• 
Kidney Surgery  
• 
Neck Surgery 
• 
Prostate Surgery  
• 
Rectal Surgery 
• 
Small Bowel 
Surgery 
• 
Spleen Surgery 
• 
Thoracic 
S
OB-GYN: 
• 
Abdominal 
Hysterectomy 
• 
Caesarean Section 
• 
Ovarian Surgery 
• 
Vaginal Hysterectomy 
 
Cardiac: 
• 
CABG - Chest Only 
• 
CABG – Chest and 
Donor 
• 
Cardiac Surgery 
• 
Pacemaker Surgery 
            
Neurosurgery:      
• 
Craniotomy  
• 
Ventricular Shunt 
• 
Laminectomy-
Discectomy 
• 
Spinal Fusion  
• 
Spinal Re-fusion 
Vascular:            
• 
AAA Repair 
• 
Atriovent Shunt Dialysis 
• 
Carotid Endarterectomy 
• 
Vascular Bypass 
         
Transplant:                    
• 
Heart Transplant 
• 
Kidney Transplant  
• 
Liver Transplant 
            
Local – Ortho:     
• 
Limb Amputation 
• 
Open Reduction 
Fracture 
• 
Other Ortho Surgery 
• 
Revision – Hip 
• 
Revision - Knee 


 
 
SWI Protocol 
07-May-2019 
 
23 
 
APPENDIX III: CASE REPORT FORMS 
 
 
 
ELIGIBILITY AND ENROLLMENT 
…………………………………………………………………………………. 
SWI-01 
BASELINE CHARACTERISTICS 
…………………………………………………………………….………………. 
SWI-02 
INDEX SURGERY 
………………………………………………………………………………………………………… 
SWI-03 
INDEX HOSPITAL DISCHARGE 
…………………………………………………………………………………… 
SWI-04 
POSTOP LABORATORY RESULTS 
………………………………………………………………………………… 
SWI-05 
 
 
 
 
 


 
 
S WI Pr ot oc ol  
0 7- M a y - 2 0 1 9 
 
2 4 
 
S WI -0 1: ELI GI BILI T Y A N D E N R OLL M E N T  
P A TI E N T I D: _ _  - _ _ _ _ _ _ 
_ _  
 
 
I N CL U SI O N C RI T E RI A: ALL R E S P O N S E S M U S T B E Y E S  F O R ELI GI BILI T Y  
1.  
A bl e t o si g n I nf or m e d C o ns e nt a n d R el e as e of M e dic al I nf or m ati o n F or m  
 Y es  
 N o  
2.  
A g e ≥ 1 8 y e ars  
 Y es  
 N o  
3.  
U n d er g oi n g c ar di ac s ur g er y wit h c o m pl et e st er n ot o m y (i ncl u di n g r e-
o p er ati o ns)  
 Y es  
 N o  
 
 
E X CL U SI O N C RI T E RI A: ALL R E S P O N S E S M U S T B E N O  F O R ELI GI BILI T Y  
1.  
E vi d e nc e of activ e i nf ecti o n ( a ny c ult ur e p ositi v e or bl o o d p ositi v e i nf ecti o n)  
 Y es  
 N o  
2.  
U n d er g oi n g or g a n tr a ns pl a nt ati o n  
 Y es  
 N o  
3.  
K n o w n hy p ers e nsiti vit y t o v a nc o myci n  
 Y es  
 N o  
4.  
Pr e g n a nt or n ursi n g w o m e n  
 Y es  
 N o  
5. 
M e nt al i m p air m e nt or ot h er c o n diti o ns t h at m a y n ot all o w p artici p a nt t o 
u n d erst a n d t h e n at ur e, si g nific a nc e, a n d sc o p e of st u dy  
 Y es  
 N o  
 
 
Si g n at ur e:  
 
I nv esti g at or/ C o or di n at or 
 
D at e:   
D D/ M M M/ Y Y Y Y  
 
 
 
 
 
 


 
 
S WI Pr ot oc ol  
0 7- M a y - 2 0 1 9 
 
2 5 
 
S WI -0 2: B A S ELI N E C H A R A C T E RI S TI C S  
P A TI E N T I D: _ _  - _ _ _ _ _ _ 
_ _  
 
1.  
L ast N a m e: _ _ _ _ _ _ _ _ _ _ _ _ _ _ 
First N a m e: _ _ _ _ _ _ _ _ _ _ _ _ _ _  
2.  
D at e of birt h ( D D/ M M M/ Y Y Y Y ): 
_ _ _ _ / _ _ _ _ _ _ / _ _ _ _ _ _ _ _  
3.  
P H N/ ULI #:  
 
4.  
H os pit al I D #:  
 
 
5.  W al ki n g  
 
 
 
    N o pr o bl e ms  
 
 
 
    Assist e d  
 
 
 
    Pr ost h esis  
 
 
 
    C o m m e nts: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
 
 
6.  I m m u n e d efici e nc y 
 Y es  
 N o  
 
    S p ecify: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
 
 
 
L A B O R A T O R Y P A R A M E T E RS 
H e m at ol o gy Ass ess m e nt D at e ( D D/ M M M/ Y Y Y Y ): 
1.  
H e m o gl o bi n ( H G B)  
 g/L 
2.  
H e m at ocrit ( H C T)  
.
 L/L 
3.  
Pl at el et C o u nt ( PL T)  
 1 0 9/L 
4.  
W hit e Bl o o d C ell C o u nt ( W B C)  
. 1 0 9/L 
5.  
N e utr o p hil C o u nt ( N E U T)  
. 1 0 9/L 
6.  
L y m p h ocyt e C o u nt (L Y M P H) 
. 1 0 9/L 
7.  
M o n ocyt e C o u nt ( M O N O)  
. 1 0 9/L 
8.  
E osi n o p hil C o u nt ( E O S)  
. 1 0 9/L 
9.  
B as o p hil C o u nt ( B A S O)  
. 1 0 9/L 
Bl o o d C h e mistry Ass ess m e nt D at e (D D/ M M M/ Y Y Y Y ): 
1 0 . 
S o di u m ( N a)  
 m m ol/L  
1 1 . 
P ot assi u m ( K)  
. m m ol/L  
1 2 . 
Ur e a  
. m m ol/L  
1 3. 
Cr e ati ni n e ( C R)  
 u m ol/L  
1 4. 
Gl o m er ul ar filtr ati o n r at e ( G F R)  
 mL/ mi n/ 1. 7 3 m 2 
 


 
 
S WI Pr ot oc ol  
0 7- M a y - 2 0 1 9 
 
2 6 
 
Si g n at ur e:  
 
I nv esti g at or/ C o or di n at or 
 
D at e:   
D D/ M M M/ Y Y Y Y  
S WI -0 3 : I N D E X S U R G E R Y 
P A TI E N T I D: _ _  - _ _ _ _ _ _ _ _  
 
 
S T U D Y P R O D U C T S Y RI N G E  I D E N TI FI C A TI O N N U M B E R:  _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
 
 
1.  S ur g er y d at e (D D/ M M M/ Y Y Y Y ): 
_ _ _ _ / _ _ _ _ _ _ / _ _ _ _ _ _ _ _  
2.  W as t h e c h est cl os e d i n t h e O R ? 
 Y es          N o  
 
 
A D V E R S E R E A C TI O N S T O S T U D Y P R O D U C T  
1.  W as t h er e e vi d e nc e of a n all er gic r e acti o n al o n g t h e st er n al w o u n d wit hi n 2 4 
h o urs of  g a uz e a p plic ati o n?   
 Y es  
 N o  
 
 
 
 
 
 
D E S C RI B E : 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Si g n at ur e:  
 
 
 
D at e:   
D D/ M M M/ Y Y Y Y  
 
 
 
 


 
 
S WI Pr ot oc ol  
0 7- M a y - 2 0 1 9 
 
2 7 
 
S WI -0 4 : I N D E X H O S PI T AL DI S C H A R G E 
P A TI E N T I D: _ _  - _ _ _ _ _ _ _ _  
 
 
DI S C H A R G E A N TI BI O TI C M E DI C A TI O N S  
 Y es  
 N o  
 C ef az oli n ( a nc ef)  
_ _ _ _ _  g 
 
 Ci pr ofl ox aci n  
_ _ _ _ _ m g  
 
 Cli n d a m yci n  
_ _ _ _ _  m g  
 
 Fl a gyl  
_ _ _ _ _ m g  
 
 G e nt a mici n  
_ _ _ _ _ m g/k g  
 
 V a nc o m yci n  
_ _ _ _ _ g  
 
 Ot h er (s p ecif y): _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
 
 
Si g n at ur e:  
 
 
 
D at e:   
D D/ M M M/ Y Y Y Y  
 
 


 
 
SWI Protocol 
07-May-2019 
 
28 
 
SWI-05: POSTOP LABORATORY RESULTS (1:2) 
PATIENT ID: __  - __ __ __ 
__ 
 
 
ASSESSMENT 
DATE AND TIME 
LABORATORY TEST 
CR 
(umol/L) 
GFR 
(mL/min/1.73m2) 
Urea 
(mmol/L) 
Na 
(mmol/L) 
K 
(mmol/L) 
HGB 
(g/L) 
HCT 
(L/L) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Signature: 
 
Investigator/Coordinator 
 
Date: 
 
DD/MMM/YYYY 
 


 
 
SWI Protocol 
07-May-2019 
 
29 
 
 
 


 
 
SWI Protocol 
07-May-2019 
 
30 
 
SWI-05: POSTOP LABORATORY RESULTS (2:2) 
PATIENT ID: __  - __ __ __ 
__ 
 
 
ASSESSMENT 
DATE AND TIME 
LABORATORY TEST 
PLT 
(109/L) 
WBC 
(109/L) 
NEUT  
(109/L) 
LYMPH 
(109/L) 
MONO 
(109/L) 
EOS 
(109/L) 
BASO 
(109/L) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Signature: 
 
Investigator/Coordinator 
 
Date: 
 
DD/MMM/YYYY