drugset / Trial / NCT05535725

Application of Powdered Vancomycin in the Surgical Wound in Haiti

NCT05535725

Phase 4 Completed 230 enrolled Clinique Ortos
RandomizedParallel-groupTriple-blindPrevention

Summary

Vancomycin, a tricyclic glycopeptide antibiotic, was originally indicated for the treatment of penicillin-resistant S. Aureus. It has a bactericidal action, inhibiting the biosynthesis of the cell wall of Gram-positive bacteria. Various studies have reported the application of intraoperative vancomycin powder to the wound prior to wound closure as a method of antibiotic prophylaxis. Intrasite administration of the drug should theoretically minimize rapid absorption into the systemic circulation, thereby reducing drug-associated side effects. The precipitated concentration gradient between the local wound and the scaffold should also reduce the occurrence of drug resistance. In Haiti, monitoring patients post-operatively is often difficult. The Mortality, Morbidity and Use of Services Survey (EMMUS-VI 2016-2017) reports that the non-use of a health facility is motivated in 58% of cases by the excessively high economic cost of care. Also, SSIs represent a challenge for clinicians. The best solution to the consequences of SSI in this context is prevention. In the present study, the investigator tested the hypothesis that the use of vancomycin powder in the surgical wound would decrease the occurrence of SSI.

Timeline

Start
2019-10-10
Primary completion
2021-10-10
Completion
2022-04-05

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Vancomycin Other / unclassified 1 g Topical
Subject Vancomycin Other / unclassified 2 g Topical

Indications

No indication recorded.