Application of Powdered Vancomycin in the Surgical Wound in Haiti - Trial NCT05535725
Access comprehensive clinical trial information for NCT05535725 through Pure Global AI's free database. This Phase 4 trial is sponsored by Clinique Ortos and is currently Completed. The study focuses on Surgical Site Infection. Target enrollment is 230 participants.
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Study Focus
application of powdered vancomycin in the surgical wound as prophylaxis against the occurrence of surgical site infection
Interventional
drug
Sponsor & Location
Clinique Ortos
Timeline & Enrollment
Phase 4
Oct 10, 2019
Apr 05, 2022
Primary Outcome
Crossover between ISOs and the two study groups,age,sexe,origin,comorbidity,habits,type of surgery,Timing of the surgery
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.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT05535725
Non-Device Trial

