NCT05535725

Application of Powdered Vancomycin in the Surgical Wound in Haiti

Single Blinded Randomized Clinical Trial on the Application of Powdered Vancomycin in the Surgical Wound as Prophylaxis Against the Occurrence of Surgical Site Infection at La Paix State University Hospital Haiti
Clinique Ortos·Phase 4·ClinicalTrials.gov·drugCompleted
View on ClinicalTrials.gov
Study focus
Disease/Condition
Surgical Site Infection
Drug/Device/Intervention
application of powdered vancomycin in the surgical wound as prophylaxis against the occurrence of surgical site infection
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Clinique Ortos
Location
Port-au-Prince, Haiti
Timeline & enrollment
Phase
Phase 4
Start date
Oct 10, 2019
End date
Apr 05, 2022
Enrollment
230 participants
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
Infection following a procedure, not elsewhere classifiedBacterial infection of unspecified siteOther bacterial infections of unspecified siteInfection of obstetric surgical woundOther specified local infections of skin and subcutaneous tissue
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT05535725
Type
Non-Device Trial
About this record

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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