跳至主要内容
临床试验/NCT01237730
NCT01237730Unknown不适用

Impact of Oropharyngeal Microorganism Colonization on the Peristomal Infection After Percutaneous Endoscopic Gastrostomy and the Effect of Tailored Antibiotics Prophylaxis

National Cheng Kung University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2010年7月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
100
试验地点
1
主要终点
Peristomal wound infection

研究概览

简要总结

Tailored antibiotic prophylaxis according to the individual throat swab culture could reduce the peristomal infection rate

详细描述

Past know-how:

Antibiotic prophylaxis has been shown to be effective to reduce peristomal infection.[9-11] The penicillin-or cephalosporin-based antibiotic prophylaxis are usually used with similar efficacy.[12] EuropeanSociety of Gastrointestinal Endoscopy (ESGE) guideline recommend that a single dose of intravenous cephalosporin orpenicillin as preparation before PEG.[17] The updated practice guidelines of American Society for Gastrointestinal Endoscopy (ASGE) and British Society of Gastroenterology (BSG) also recommend cefazolin or cefuroxime as prophylactic antibiotics.[18-19]

Question:

Is the 1st or 2nd generation cephalosporin is adequate as prophylactic antibiotics for percutaneous endoscopic gastrostomy (PEG)?

Preliminary results:

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
None

入排标准

年龄范围
20 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • The patients who receive PEG by pull method in our hospital, a tertiary transferring center, will be included

排除标准

  • The exclusion criteria for entry are inability to place the gastrostomy for technical reasons, such as oropharyngeal deformity or esophageal stricture. The patients who receive PEG by percutaneous push method will be excluded. The patients will be also excluded if active infection and fever are identified, and the PEG is delayed until the infection is brought under control.

研究组 & 干预措施

Cefuroxime group

Active Comparator

Use the cefuroxime as prophylactic antiobiotics, according to the clinical guideline.

干预措施: cefuroxime (Drug)

Tailored antibiotics group

Experimental

Tailored antibiotic is selected according to the patient's oropharyngeal microorganisms.

干预措施: Tailored antibiotic (Drug)

结局指标

主要结局

Peristomal wound infection

时间窗: Two weeks after operation of PEG

次要结局

未报告次要终点

研究者

申办方类型
Other

研究点 (1)

Loading locations...

相似试验