Study on the Effect of the Universal Decontamination With Daily Bathing With 4% Chlorhexidine Gluconate on the Incidence of Hospital Acquired Infections in Intensive Care Units
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 449
- 主要终点
- hospital acquired infections incidence
研究概览
简要总结
The study will assess the utility of 4% chlorhexidine gluconate (CHG) daily bathing to reduce hospital acquired infections in patients admitted to intensive care units. One group will be daily bathed with 4% CHG and the other group with standard soap.
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
- Double (Investigator, 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
- •admission to the intensive care unit (ICU) or to the post-operative cardiosurgical ICU (PC-ICU)
- •ICU/PC-ICU stay for at least 1 night
排除标准
- •known allergy to chlorhexidine
- •burns, toxic epidermal necrolysis or Stevens-Johnson syndrome as admission diagnosis
- •pregnancy
研究组 & 干预措施
Intervention Arm
daily bathing with 4% chlorhexidine gluconate soap-like solution followed by water rinsing
干预措施: 4% chlorhexidine gluconate soap-like solution (Drug)
Control Arm
daily bathing with standard soap
干预措施: standard soap (Other)
结局指标
主要结局
hospital acquired infections incidence
时间窗: infections occured 48 hours after admission to ICU/PC-ICU
cumulative incidence of bloodstream infections (BSI), central line-associates BSI (CLABSI), urinary tract infections (UTI), catheter-associated UTI (CAUTI) and ventilator-associated pneumonias (VAP)
次要结局
- Ventilator-associated pnemonias (VAP) incidence(infections occured 48 hours after admission to ICU/PC-ICU)
- Bloodstream infections (BSI) incidence(infections occured 48 hours after admission to ICU/PC-ICU)
- central-line associated BSI (CLABSI) incidence(infections occured 48 hours after admission to ICU/PC-ICU)
- urinary tract infections (UTI) incidence(infections occured 48 hours after admission to ICU/PC-ICU)
- catheter associated UTI (CAUTI) incidence(infections occured 48 hours after admission to ICU/PC-ICU)
- 4% CHG daily bathing safety(at discharge, approximately up to 10 days)
- 4% CHG daily bathing-related adverse events(at discharge, approximately up to 10 days)
- time till infection(at discharge, approximately up to 10 days)
研究者
Carlo Pallotto
Medical Doctor, Principal investigator
University Of Perugia