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NCT04500275
Topical Vancomycin Over Sternal Edge in Cardiac Surgery
Phase 4 trial testing Vancomycin Hydrochloride in Sternal Wound Infection in 360 participants. Completed in 31 March 2025.
31 March 2025
Quick facts
| Lead sponsor | National Cheng-Kung University Hospital |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | prevention |
| Enrollment | 360 |
| Start date | 1 July 2020 |
| Primary completion | 31 March 2025 |
| Estimated completion | 31 March 2025 |
| Sites | 1 location across Taiwan |
Drugs / interventions tested
- Vancomycin Hydrochloride — full drug profile →
- Normal Saline
Conditions studied
- Sternal Wound Infection — all drugs for Sternal Wound Infection →
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):
-
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
Verify or expand the search:
- PubMed search for NCT04500275
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other National Cheng-Kung University Hospital trials
Trials by the same sponsor.
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- NCT07257926 — Prevention of Delayed Post-polypectomy Bleeding by Endoscopic Sucralfate Spray in High-risk Patients: A Randomized Contr · Phase 4 · not yet recruiting
- NCT07269132 — Applying the ADDIE Model to Develop a Multimedia Program to Enhance Chemotherapy Knowledge and Self-Efficacy Among Inten · NA · enrolling by invitation
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04500275 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by National Cheng-Kung University Hospital
- Last refreshed: 8 April 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04500275.
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