Topical Vancomycin Paste Over Sternal Edge: Safety and Effect of on Incidence of Sternal Wound Infection After Cardiac Surgery

A-BR-109-013

This is a single-blind 1:1 randomized controlled trial based on the hypothesis that topical application of vancomycin paste over sternum edge is safe and can reduce sternal wound infection after elective cardiac surgery. Vancomycin paste will be prepared using 2.5 g of vancomycin mixed with 2 ml normal saline. Vancomycin paste as control or 2 ml normal saline as placebo will be spread on sternal edge immediately after sternotomy and before sternal closure. The safety of Vancomycin paste over sternum edge will be assessed according to postoperative serum Vancomycin exposure and potential side effects such as renal toxicity or bacterial resistance. Effect of topical Vancomycin on incidence of postoperative sternal wound infection will be assessed on postoperative 7, 30, and 90 days.

2020-07-01

2024-12-31

2024-12-31

Recruiting

Early phase I

360

Inclusion Criteria: * All adult patients admitted for elective cardiac surgery via first-time full sternotomy, such as coronary artery disease, valvular heart disease, adult congenital heart disease, aortic aneurysm. Exclusion Criteria: * redo sternotomy surgery * minimal invasive or non-full-sternotomy cardiac surgery * emergent surgery with preoperative shock or cardiopulmonary resuscitation * heart transplant or ventricular assist device surgery * patients who have any preoperative mechanical support including IABP, ECMO, or ventricular assist device * evidence of Vancomycin allergy * preexisting infection requiring preoperative regular antibiotics * perioperative immunosuppressive requirement * Patients with known cephalosporin or beta-lactam allergy who requires Vancomycin plus Gentamicin for intravenous prophylaxis will also be excluded because the intravenous Vancomycin will affect the further measurement of serum Vancomycin level after topical application

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 360, 'type': 'ESTIMATED'}}

2024-03-21