Topical Use of Vancomycin in Reducing Sternal Wound Infection in Cardiac Surgery (SWI Trial)

Study Overview
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Brief Summary
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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
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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.

Official Title
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Topical Use of Vancomycin in Reducing Sternal Wound Infection in Cardiac Surgery (SWI Trial)

Conditions
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INFECTION

Intervention / Treatment
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* Drug: Vancomycin
* Other: No Vancomycin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vancomycin<br>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 | Drug: Vancomycin<br>* Topical prophylactic antibiotic<br>* Other names: Vancomycin Hydrochloride;|
| Placebo Comparator: Control<br>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 | Other: No Vancomycin<br>* Placebo: Sterile water. No Vancomycin.<br>* Other names: Sterile water;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Sternal Wound Infections | The number of sternal wound infections at 3 months postoperative. This includes superficial incisional, deep incisional, and organ/space surgical site infections. | 3 months postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Sternal Wound Infections | The number of sternal wound infections at 1 year postoperative. This includes superficial incisional, deep incisional, and organ/space surgical site infections. | 1 year postoperative | 
| Hospitalization | Duration of index hospitalization and subsequent re-admissions due to sternal wound infection. | 1 year postoperative | 
| Number of Participants With Use of Prophylactic Antibiotics | Number of participants with use of prophylactic antibiotics before surgery | Assessed before surgery | 
| Cost Analysis for Sternal Wound Infection Treatment | Cost analysis for sternal wound infection treatment post-operatively | 1 year postoperative | 
| Adverse Events | Adverse events during study participation | 1 year postoperative |