Status:
COMPLETED
Topical Vancomycin Over Sternal Edge in Cardiac Surgery
Lead Sponsor:
National Cheng-Kung University Hospital
Conditions:
Sternal Wound Infection
Eligibility:
All Genders
20+ years
Phase:
PHASE4
Brief 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 elect...
Detailed Description
1\. Patient Recruitment and Group Assignment 1. Institution. All the surgical procedures will be undertaken in the National Cheng Kung University Hospital (NCKUH) under service of the Cardiovascular ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2025
Estimated Enrollment :
360 Patients enrolled
Trial Details
Trial ID
NCT04500275
Start Date
July 1 2020
End Date
March 31 2025
Last Update
April 8 2025
Active Locations (1)
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1
National Cheng Kung University Hospital
Tainan, 台南市, Taiwan, 704