Topical Use of Vancomycin in Reducing Sternal Wound Infection in Cardiac Surgery (SWI Trial)
- Registration Number
- NCT02374853
- Lead Sponsor
- University of Alberta
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 1037
- Able to sign Informed Consent and Release of Medical Information Form
- Age ≥ 18 years
- Undergoing cardiac surgery with complete sternotomy (including re-operations)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control No Vancomycin 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 Vancomycin Vancomycin 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
- Primary Outcome Measures
Name Time Method Number of Sternal Wound Infections 3 months postoperative The number of sternal wound infections at 3 months postoperative. This includes superficial incisional, deep incisional, and organ/space surgical site infections.
- Secondary Outcome Measures
Name Time Method Hospitalization 1 year postoperative Duration of index hospitalization and subsequent re-admissions due to sternal wound infection.
Cost Analysis for Sternal Wound Infection Treatment 1 year postoperative Cost analysis for sternal wound infection treatment post-operatively
Number of Participants With Use of Prophylactic Antibiotics Assessed before surgery Number of participants with use of prophylactic antibiotics before surgery
Adverse Events 1 year postoperative Adverse events during study participation
Number of Sternal Wound Infections 1 year postoperative The number of sternal wound infections at 1 year postoperative. This includes superficial incisional, deep incisional, and organ/space surgical site infections.