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临床试验/NCT00859235
NCT00859235Unknown3 期

Predicting Oral Care Before Percutaneous Endoscopic Gastrostomy (PEG). The Influence of Oral Hygiene on Local Wound and Systemic Infection in Patients With PEG Placement

Hillel Yaffe Medical Center0 个研究点目标入组 50 人开始时间: 2009年5月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
入组人数
50
主要终点
Assess impact mouth wash (containing 0.2% Chlorhexidine gluconate) (Taro Pharmaceutical Industries Haifa Israel) prior PEG insertion.

研究概览

简要总结

Percutaneous endoscopic gastrostomy (PEG) is commonly used for long term enteral feeding of patients with severe dysphagia. The most common complication is peristomal wound infection. The possible mechanism the bacterial from the oral cavity disseminate during the PEG insertion through the stomach to the abdominal wall, in spite the routine use of antibiotic prophylaxis, have reported low rates of wound infection in patients who were already receiving antibiotics at the time of PEG Our hypothesis that washing the oral cavity with antibiotic solution prior the insertion PEG , We planned a prospective, randomised, double blind, one centre study of antibiotic mouth wash solution (0.2% Chlorhexidine gluconate) as.prophylaxis in PEG

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
Single (Participant)

入排标准

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

入选标准

  • All patients scheduled to undergo PEG

排除标准

  • Previous GI surgery
  • Coagulopathy

研究组 & 干预措施

1

Active Comparator

干预措施: Chlorhexidine gluconate 0.2% (Drug)

2. Plain water

Placebo Comparator

干预措施: Plain water (Other)

结局指标

主要结局

Assess impact mouth wash (containing 0.2% Chlorhexidine gluconate) (Taro Pharmaceutical Industries Haifa Israel) prior PEG insertion.

时间窗: One month

次要结局

  • Follow the peristomal wound infection in patients who had prepared by mouth wash to a group a patients without mouth washing.(One month)

研究者

申办方类型
Other Gov

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