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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 230 (actual)
• Sponsor: Clinique Ortos · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

Type of study This is a single-center prospective study with balanced blind randomization 1: 1 in parallel group. Method and materials After approval of the research protocol by the hospital ethics committee, the randomization sequence will be created using Stata 9.0 ware statistical software and will be stratified by center with a 1:1 allocation using random block sizes of 2, 4 and 6." "Participants will be randomly assigned following simple randomization procedures to 1 of 2 treatment groups. A group of patients will receive 2g of powdered vancomycin in the operative wound before its closure, and another group will not receive it. Both groups will benefit from the same preoperative asepsis protocol. One hour before the incision, 1g of intravenous ceftriaxone will be administered to the patients, this dose is maintained during the 48 hours postoperative every 12 hours. At discharged the two groups of patients will receive oral cloxacilin 500mg three times a day for one week. Patients are dressed every 2 days until the surgical wound has healed. Patients will be seen in the outpatient clinic at 2, 4, and 6 weeks, then at one year. The significance level for the statistical tests is 0.05%. investigator used chi-square tests to assess the degree of relationship. The frequency of the patient's demographic, clinical and therapeutic characteristics are calculated. We used pubmed, google scholar, medline to perform the literature review. The consort guide will be used for the methodology.

Conditions

• Surgical Site Infection

Interventions

Type	Name	Description
DRUG	application of powdered vancomycin in the surgical wound as prophylaxis against the occurrence of surgical site infection	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 over 2 years.Both groups benefited from the same preoperative asepsis protocol. One hour before the incision, 1g of intravenous ceftriaxone is administered to the patients, this dose is maintained during the 48 hours postoperative every 12 hours. At discharged the two groups of patients received oral cloxacilin 500mg three times a day for one week. Patients are dressed every 2 days until the surgical wound has healed. Patients are seen in the outpatient clinic at 2, 4, and 6 weeks, then at one year. We selected 215 patients and retained 204.

Timeline

• Start date: 2019-10-10
• Primary completion: 2021-10-10
• Completion: 2022-04-05
• First posted: 2022-09-10
• Last updated: 2022-09-14

Locations

1 site across 1 country: Haiti