Vancomycin for Prophylaxis of PEG-Related Wound Infection in MRSA-Positive Patients: a Double-Blind, Randomized, Placebo-Controlled Study
试验速览
- 阶段
- 2 期
- 入组人数
- 96
- 试验地点
- 6
- 主要终点
- Rate of PEG-site infection at 3, 7, 14, 21 and 28 days post intervention as assessed by a clinical score (Jain score) and swab culture
研究概览
简要总结
The aim of this study is to determine whether vancomycin with cefazoline is superior to vancomycin with placebo in preventing gastrostomy-related wound infection in carriers of methicillin-resistant staphylococcus aureus (MRSA).
详细描述
Percutaneous endoscopic gastrostomy (PEG) provides an enteral route for long-term nutrition in patients unable to swallow. Peristomal wound infection occurs in 5 - 30 % of patients. Systematic antibiotic prophylaxis by cephalosporins or ampicillin/clavulanic acid has been shown to prevent this complication efficiently.
MRSA-positive patients have been suggested to be at higher risk of PEG-related wound infection due to MRSA. However, recommendations about vancomycin-prophylaxis before surgical procedures have not been extended to PEG insertion. This might be due to the fact that the exact route of contamination is unknown. It is assumed that contamination occurs when gastrostomy tubes are passed through the oropharynx. However, oropharyngeal carriage appears less frequent than nasopharyngeal or cutaneous carriage. Furthermore, patients who receive PEG are particularly vulnerable to vancomycin toxicity because of older age and multiple comorbidities.
The aim of this study is to compare the rate of infectious complications after PEG insertion in patients colonized with MRSA who received either standard intravenous antibiotic prophylaxis associated with vancomycin or standard prophylaxis with placebo.
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
- Double
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •PEG insertion in a patient with a swab positive for MRSA during the 4 weeks preceding PEG insertion
排除标准
- •Age < 18 years
- •No informed consent obtained either from the patient or from his legal representative
- •Contraindication to the administration of cefazolin or of vancomycin
- •Systemic administration of antibiotics effective against MRSA during the week prior to the procedure
- •Technique of PEG insertion different from the standard pull technique proposed by the physician in charge and the gastroenterologist
- •Patients requiring antibiotic prophylaxis of endocarditis
结局指标
主要结局
Rate of PEG-site infection at 3, 7, 14, 21 and 28 days post intervention as assessed by a clinical score (Jain score) and swab culture
次要结局
- Additional costs and nursing charges (Programme de Recherche en Nursing (PRN) scoring system)