Application of Powdered Vancomycin in the Surgical Wound in Haiti

Phase 4

Completed

• Conditions: Surgical Site Infection
• Interventions: Drug: application of powdered vancomycin in the surgical wound as prophylaxis against the occurrence of surgical site infection

• Registration Number: NCT05535725
• Lead Sponsor: Clinique Ortos

Brief 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.

Study Timeline

• Study Start: 2019-10-10
• Primary Completion: 2021-10-10
• Study Completion: 2022-04-05
• Study First Submitted: 2022-08-07
• Status Verified: 2022-09
• Study First Submitted QC: 2022-09-06
• Study First Posted: 2022-09-10
• Last Update Submitted: 2022-09-12
• Last Update Posted: 2022-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 230

Inclusion Criteria

• patients with 18 years and older
• lower extremity fractures

Exclusion Criteria

• patients with impaired consciousness,
• those with an open Gustillo and Anderson type III fracture
• those with a C reactive protein > 6.
• those with date of trauma more than 48 hours
• those with passage of purulent secretion in the wound

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
expose	application of powdered vancomycin in the surgical wound as prophylaxis against the occurrence of surgical site infection	A group of patients receiving 1g of powdered vancomycin in the operative wound before its closure, and another group not receiving it

Primary Outcome Measures

Name	Time	Method
age	12 month	age: quantitative variable the age written on the national identification card Average age =(sum of study ages)/(number of study patients)
origin	12 month	qualitative variable. the place where the patient lives. frequency origin X = Number of cases of X / number of total cases this variable has 2 modalities: 1 patient from the capital 2) patient from outside of the capital
comorbidity	12 month	qualitative variable. Association of two diseases, mental or physical, frequently observed in the population frequency comorbidity X = Number of cases of X / number of total cases
type of surgery	12 month	the surgical technique used this variable qualitative has 6 modality (nail, plate, prothesis, DHS, pinning, vissage, cerclage) frequency X = Number of cases of X / number of total cases
Crossover between ISOs and the two study groups	12 month	Crossover Chi Square between ISOs and the two study groups. the significant value of p=0.005.
sexe	12 month	this variable is qualitative and has three modalities 1) male 2) female 3) orther frequency sex X = Number of cases of X / number of total cases Sexeratio=(majority sex)/(minority sex)
Timing of the surgery	12 month	the surgical timing :the time elapsed between the incision and the closure of the skin this variable qualitative has 3 modality ; Less than 1 h ;1 to 2h ; More than 2h; frequency X = Number of cases of X / number of total cases
habits	12 month	qualitative variable. mores, customs, customs specific to the patient frequency comorbidity X = Number of cases of X / number of total cases this variable has 2 modalities 1) alcoholic 2)smoker

Trial Locations

Locations (1)

Cliniques Orthos; 🇭🇹 Port-au-Prince, Haiti