Chlorhexidine-impregnated Sponge Dressing for Prevention of Catheter Exit Site Infection in Incident Peritoneal Dialysis Patients - a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Exit-site/tunnel infection rate
研究概览
简要总结
The purpose of the study is to evaluate the efficacy and safety of chlorhexidine-impregnated disk in preventing catheter exit-site infection in peritoneal dialysis patients
详细描述
The primary aim of the study is to examine the exit-site infection rate in patients using chlorhexidine-impregnated dressing.
The participant will be followed up at 2, 6, 12, 24, 36 and 52 weeks of study and during each visit the catheter exit-site will be examined by one of the investigators for any sign of infection or allergic reaction, and questionnaires about satisfaction with use of study material (biopatch) will be asked by a study team member at the 12 week visit of the study. Each participant will be followed up for one year.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All adult incident peritoneal dialysis patients between 21 to 90 years old, who are followed up in Singapore General Hospital
排除标准
- •patients who have known history of allergy to chlorhexidine
- •patients who had previous history of peritoneal dialysis catheter exit-site infection
- •patients with mentally challenging conditions who are unable to give the valid consent for the study
- •patients who have been involved in another study for exit site infection
结局指标
主要结局
Exit-site/tunnel infection rate
时间窗: one year
Exit-site/tunnel infection rate (reported as episodes per patient-year) in patients receiving chlorhexidine-impregnated disk
次要结局
- Time to the first episode of exit-site/tunnel infection(one year)
- time to first episode of peritonitis(one year)
- Peritoneal dialysis infection-related hospitalization(one year)
- comparison of the above outcomes with historical cohort using topical antibiotics cream(one year)
- adverse events(one year)
- mortality(one year)
- patient satisfaction with the use of chlorhexidine-impregnated sponge dressing(third month of study)
- peritonitis rate(one year)
- technique failure rate(one year)