A Phase 4 interventional study of application of powdered vancomycin in the surgical wound as prophylaxis against the occurrence of surgical site infection in Surgical Site Infection, sponsored by Clinique Ortos. Completed at 1 site in Haiti. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-09-14.
Sponsored by Clinique Ortos · Phase 4, Interventional, and Prevention
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.
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.
745 studies on the registry are indexed under Surgical Wound Infection; 151 are open to participants now.
This study's enrollment of 230 is above the median of 200 across 581 interventional studies indexed under Surgical Wound Infection.
Browse Surgical Wound Infection studies →This is the only study on the registry with Clinique Ortos as lead sponsor.
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Exclusion Criteria:
A group of patients receiving 1g of powdered vancomycin in the operative wound before its closure, and another group not receiving it
Drug: application of powdered vancomycin in the surgical wound as prophylaxis against the occurrence of surgical site infection
A group of patients not receiving 1g of powdered vancomycin in the operative wound before its closure
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.
Crossover between ISOs and the two study groups
Crossover Chi Square between ISOs and the two study groups. the significant value of p=0.005.
Time frame: 12 month
age
age: quantitative variable the age written on the national identification card Average age =(sum of study ages)/(number of study patients)
Time frame: 12 month
sexe
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)
Time frame: 12 month
origin
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
Time frame: 12 month
comorbidity
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
Time frame: 12 month
habits
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
Time frame: 12 month
type of surgery
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
Time frame: 12 month
Timing of the surgery
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
Time frame: 12 month
Plan to share: No
Ran from Oct 2019 to primary completion in Oct 2021, 24 months.
Of 44 non-industry phase 4 interventional studies under Surgical Wound Infection, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 51. This study's 24 months is below that.
Counting every sponsor, half of 46 studies reached it within 30 months; a quarter within 16 and three quarters within 51.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.
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