Antibiotic Prophylaxis for Percutaneous Endoscopic Gastrostomy (PEG) in Children: a Randomised Controlled Trial.
试验速览
- 阶段
- 4 期
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Efficacy
研究概览
简要总结
The aim of this study is to evaluate if a single i.v. dose of co-amoxiclav before PEG can reduce the incidence of peristomal wound infection in the paediatric population.
详细描述
Percutaneous Endoscopic Gastrostomy (PEG) is a common endoscopic procedure, performed to avoid malnutrition in various pathological conditions.
Gastrostomy tube placement is associated with intra and postoperative complications both in the adult and in the paediatric population.
Local infection is the most common complication following PEG.
Antibiotic prophylaxis is a well-established strategy to reduce peristomal wound infection rate in adult population.
The aim of this study is to evaluate if a single i.v. dose of co-amoxiclav before PEG can reduce the incidence of peristomal wound infection in the paediatric population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 1 Month 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All pediatric patients (0-18 years) who will refer for PEG placement to the endoscopy unit
排除标准
- •Controindications for PEG
- •Ongoing antibiotic treatment
- •Antibiotic use within the past 4 days
- •Illness too severe to allow the patient to participate
- •Allergy to penicillin
研究组 & 干预措施
placebo
Placebo
干预措施: Placebo (Dietary Supplement)
co-amoxiclav
co-amoxiclav is a combination antibiotic consisting of amoxicillin trihydrate, a β-lactam antibiotic, and potassium clavulanate, a β-lactamase inhibitor
干预措施: co-amoxiclav (Drug)
结局指标
主要结局
Efficacy
时间窗: 14 days after PEG insertion
14 days after PEG insertion PEG site will be examined for erythema, induration and exudate and scored using the peristomal sepsis scoring system.
次要结局
- Efficacy(14 days after PEG insertion)
研究者
Giovanni Di Nardo
MD
Azienda Policlinico Umberto I