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临床试验/NCT01629550
NCT01629550已完成4 期

Prospective Randomized Controlled Multicenter Trial of 4 Antiseptic Strategies for Prevention of Catheter Infection in Intensive Care Unit for Adults Patients

Poitiers University Hospital5 个研究点 分布在 1 个国家目标入组 2,400 人开始时间: 2012年10月1日最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
已完成
入组人数
2,400
试验地点
5
主要终点
Major catheter related infection

研究概览

简要总结

Catheter related infection is the third cause of nosocomial infection in ICUs. Most of them are avoidable and can be prevent by improving aseptic practices during catheter insertion and maintenance. Indeed, the main route of catheter contamination for short-term catheters is the insertion site. Consequently, the quality of skin disinfection is the most effective preventive measure to reduce the incidence of these infections.

This aim of the present study is to compare four strategies of skin disinfection to determine whether a 2% alcoholic solution of chlorhexidine acts better than 5% alcoholic povidone iodine in reducing catheter infection and to assess whether a detersion phase prior to disinfection reduces catheter colonization as compared with no detersion.

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
None

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

  • •≥ 18 year-old
  • •Expected duration of ICU stay ≥ 48 hours
  • •Patient requiring the insertion of at least one arterial catheter and/or central venous catheter and/or catheter for hemodialysis.

排除标准

  • •Patient with history of allergy to any of the antiseptic agent studied
  • •Expected survival < 48 hours
  • •Catheter inserted outside the ICU or in emergency without respect of preventive measures.
  • •Use of antimicrobial impregnated catheters or antiseptic impregnated dressings.
  • •Pregnant woman or breast-feeding mother

研究组 & 干预措施

PVI paint

Active Comparator

5% alcoholic povidone iodine paint

干预措施: skin disinfection prior catheter insertion (Procedure)

PVI scrub and paint

Active Comparator

detersion with 4% povidone iodine scrub followed by 5% alcoholic povidone iodine paint

干预措施: skin disinfection prior catheter insertion (Procedure)

Chlorhexidine paint

Active Comparator

2% alcoholic chlorhexidine paint

干预措施: skin disinfection prior catheter insertion (Procedure)

chlorhexidine scrub and paint

Active Comparator

Detersion with 4% chlorhexidine scrub followed 2% alcoholic chlorhexidine paint

干预措施: skin disinfection prior catheter insertion (Procedure)

结局指标

主要结局

Major catheter related infection

次要结局

  • Skin allergy and anaphylactic shock
  • Mortality due to catheter infection
  • Catheter related bacteremia
  • Catheter colonization
  • Colonization insertion site
  • Prolongation hospitalization due to catheter infection
  • Costs

研究者

申办方类型
Other
责任方
Sponsor

研究点 (5)

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