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NCT04500275

Topical Vancomycin Over Sternal Edge in Cardiac Surgery

Completed Phase 4 Last updated 8 April 2025
What this trial tests

Phase 4 trial testing Vancomycin Hydrochloride in Sternal Wound Infection in 360 participants. Completed in 31 March 2025.

Timeline
1 July 2020
Primary endpoint
31 March 2025
31 March 2025

Quick facts

Lead sponsorNational Cheng-Kung University Hospital
PhasePhase 4
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingtriple
Primary purposeprevention
Enrollment360
Start date1 July 2020
Primary completion31 March 2025
Estimated completion31 March 2025
Sites1 location across Taiwan

Drugs / interventions tested

Conditions studied

Sponsor

National Cheng-Kung University Hospital

Who can join

20 and older, any sex, with Sternal Wound Infection. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Interventions to prevent surgical site infection in adults undergoing cardiac surgery.
    Cardiothoracic Interdisciplinary Research Network, Rogers LJ, Vaja R, Bleetman D, et al · · 2024 · cited 2× · PMID 39620424 · DOI 10.1002/14651858.cd013332.pub2

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Other trials of Vancomycin Hydrochloride

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