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
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 230
- 试验地点
- 1
- 主要终点
- age
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •patients with 18 years and older
- •lower extremity fractures
排除标准
- •patients with impaired consciousness,
- •those with an open Gustillo and Anderson type III fracture
- •those with a C reactive protein >
- •those with date of trauma more than 48 hours
- •those with passage of purulent secretion in the wound
研究组 & 干预措施
expose
A group of patients receiving 1g of powdered vancomycin in the operative wound before its closure, and another group not receiving it
干预措施: application of powdered vancomycin in the surgical wound as prophylaxis against the occurrence of surgical site infection (Drug)
结局指标
主要结局
age
时间窗: 12 month
age: quantitative variable the age written on the national identification card Average age =(sum of study ages)/(number of study patients)
origin
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 12 month
Crossover Chi Square between ISOs and the two study groups. the significant value of p=0.005.
sexe
时间窗: 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
时间窗: 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
时间窗: 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
次要结局
未报告次要终点
研究者
Augustin Delange Hendrick
principal investigator
Clinique Ortos