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Topical Vancomycin Over Sternal Edge in Cardiac Surgery

NCT04500275 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 360

Last updated 2025-04-08

No results posted yet for this study

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.

Conditions

  • Sternal Wound Infection

Interventions

DRUG

Vancomycin Hydrochloride

Vancomycin will be spread on sternal edge immediately after sternotomy and before sternal closure

OTHER

Normal Saline

2 ml normal saline will be spread on sternal edge immediately after sternotomy and before sternal closure

Sponsors & Collaborators

  • National Cheng-Kung University Hospital

    lead OTHER

Principal Investigators

  • MENG-TA TSAI, MD · National Cheng Kung University Hospital, Tainan, Taiwan

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-01
Primary Completion
2025-03-31
Completion
2025-03-31

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04500275 on ClinicalTrials.gov