Use of Advanced Fixation Dressings in Reducing Central Venous Catheter-related Bloodstream Infections in a Paediatric Intensive Care Unit
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Incidence of central venous catheter-related bloodstream infection (CVC-BSI)
研究概览
简要总结
Randomised, single-blind clinical trial comparing chlorhexidine gluconate-impregnated transparent dressings versus conventional transparent dressings in the prevention of central venous catheter-related bloodstream infections (CVC-BSI) in paediatric patients admitted to a tertiary hospital PICU. Outcomes include incidence of BRCVC, catheter colonisation, dressing-related skin complications, and number of dressing changes.
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)
盲法说明
This was a single-blind trial. The outcomes assessor was blinded to group allocation. Participants and care providers were aware of the dressing used
入排标准
- 年龄范围
- 2 Months 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Admission to paediatric intensive care unit (PICU)
- •Central venous catheter placement (central or peripherally inserted)
- •Informed consent obtained from parent/legal guardian
排除标准
- •Known immunological disorders
- •Neutropenia (<500/mm³)
- •Pre-existing colonisation or infection with multidrug-resistant organisms
研究组 & 干预措施
Experimental - Chlorhexidine gluconate-impregnated dressing
Participants receive advanced transparent dressings impregnated with chlorhexidine gluconate at the CVC insertion site.
干预措施: 3M™ Tegaderm™ Antimicrobial Transparent Dressing (chlorhexidine gluconate-impregnated) (Device)
Control - Conventional transparent dressing
Participants receive standard transparent polyurethane dressing without antimicrobial activity at the CVC insertion site.
干预措施: Conventional transparent polyurethane dressing (Device)
结局指标
主要结局
Incidence of central venous catheter-related bloodstream infection (CVC-BSI)
时间窗: Baseline to 4 weeks or until catheter removal
CVC-BSI confirmed by clinical signs and positive blood culture according to Bacteriemia Zero protocol.
次要结局
- Catheter colonisation rate(At catheter removal (up to 14 days after insertion))
- Skin complications at insertion site(Up to 4 weeks)
- Number of dressing changes per patient(Up to 4 weeks)
研究者
MANUEL PABON CARRASCO
Principal Investigator, Faculty of Nursing, Physiotherapy and Podiatry, University of Seville
University of Seville