Impact of Tegaderm HP and Tegaderm CHG in Major Catheter Related Infections and Dressing Detachment in ICU Patients a Prospective Randomized Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,960
- 试验地点
- 1
- 主要终点
- Risk of major catheter infection between Group 1 and Group 2+3 assessed by an independent blind expert panel
研究概览
简要总结
Catheter related infection is a frequent and life threatening event in ICU. A chlorhexidine impregnated sponge has been proven to reduce the rate of major catheter related infections in ICU patients (HR=0.39, p=0.03) (Timsit Jama 2009). However, dressings are detached in 40% of cases before planned changes and the rate of unplanned dressing is significantly associated with the major catheter related infections.
Primary objective: To demonstrate that Tegaderm CHG, a new CHG impregnated dressing decrease the rate of major catheter related infection as compared to non impregnated dressings and to demonstrate that highly adhesive dressing decrease the rate of detached dressings.
Secondary objectives:
- To demonstrate that the use of high performance dressing decrease the rate of unstuck dressing and the rate of catheter infections.
- To evaluate the tolerance of CHG impregnated gel dressings (Tegaderm CHG).
- To calculate the cost saving of each dressings
详细描述
Inclusion criteria: Patients older than 18 years old with central venous who need a central vein and/or an arterial catheter for an expected duration of more than 48 hours.
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 (Outcomes Assessor)
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
- •patients older than 18 years old with a central venous catheter or arterial catheter installed in the study departement for a maximum for 24 hours
排除标准
- •pulmonary arterial catheter
- •antiseptic-impregnated catheter
- •hemodialysis catheter
- •chlorhexidine allergy
- •emergency catheter without surgical asepsis
结局指标
主要结局
Risk of major catheter infection between Group 1 and Group 2+3 assessed by an independent blind expert panel
时间窗: 48 hours after catheter removal or ICU discharge (10 days on average)
The patients were followed 48h after catheter removal or discharge. Average follow up of 10 days.
次要结局
- dressing detachment : rate of unplanned dressing between Tegaderm CHG, Tegaderm HP and Tegaderm(until catheter removal or ICU discharge (8 days on average))
- Comparison of Group 1 to group 2+3 : catheter colonization, CR-BSI, cutaneous colonization at catheter removal, cost(48 hours after catheter removal or ICU discharge (10 days on average))