A Comparative Study to Investigate if Silver Alloyed Urinary Catheters Can Reduce the Incidence of Catheter Acquired Urinary Tract Infections in Patients Undergoing Elective Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Region Skane
- 入组人数
- 511
- 试验地点
- 3
- 主要终点
- To determine whether a silver alloyed catheter with antibacterial properties will decrease the incidence of catheter associated urinary tract infection in patients undergoing elective surgery.
研究概览
简要总结
This study is a single blinded (Outcome Assessors), multicenter randomized controlled study designed to investigate if a silver alloyed urinary catheter with antibacterial properties can reduce the incidence of catheter acquired urinary tract infections in patients undergoing elective surgery. Patients requiring urinary catheterization will be randomized into two groups and receive either the silver alloyed catheter (test) or a silicone catheter (control).
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
- •Adults in elective surgery requiring urinary catheterization
排除标准
- •Patients who has or recently (within 3 weeks) had a urinary catheter
- •Signs of urinary tracts infection
- •Previous radiation therapy in lower pelvis
- •Latex allergy
- •Cognitive impaired
- •Do not understand Swedish language.
研究组 & 干预措施
Silver alloyed urinary catheter
干预措施: Bactiguard Infection Protection (BIP) Cathter. (Device)
Silicone urinary catheter
干预措施: Silicone Urinary Catheter (Device)
结局指标
主要结局
To determine whether a silver alloyed catheter with antibacterial properties will decrease the incidence of catheter associated urinary tract infection in patients undergoing elective surgery.
时间窗: At catheter withdrawal (normally 1-3 days after catheter insertion).
次要结局
- Patient´s evaluation of the catheterization and overall satisfaction.(At catheter withdrawal and 7-10 days after catheter withdrawal.)