Overview

Topical Vancomycin Over Sternal Edge in Cardiac Surgery

Status:
Recruiting
Trial end date:
2022-12-31
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
National Cheng-Kung University Hospital
Treatments:
Vancomycin
Criteria
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