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临床试验/NCT01733940
NCT01733940Unknown4 期

Efficacy of Tegaderm-CHG® Dressing vs. Tegaderm-IV® Dressing in the Reduction of Central Catheter Colonization in Patients of the Intensive Care Unit of the University "Gómez Ulla" Hospital.

Hospital Central de la Defensa Gómez Ulla2 个研究点 分布在 1 个国家目标入组 398 人开始时间: 2012年9月1日最近更新:
适应症

试验速览

阶段
4 期
发起方
入组人数
398
试验地点
2
主要终点
Incidence of intravascular central catheter colonization.

研究概览

简要总结

Introduction: The vascular catheter-related bacteremia (BRC) is a major health problem in intensive care units. The use of dressings containing chlorhexidine gluconate (CHG) can decrease the catheters colonization, closely related to infection thereof.

Objective: To determine the efficacy of the dressing "Tegaderm CHG" dressings versus "Tegaderm IV" dressings in reducing the risk of colonization of central intravascular catheters in the intensive care unit (ICU).

Methods: Randomized controlled trial with blinding professional who reviews the main outcome. The study included patients over 18 years, indicating the central intravascular catheter implantation in the ICU or in the operating room, prior informed consent. Excluding subjects with positive blood culture at the time of catheter implantation.

The estimated sample size is 398 patients, with a confidence level of 95% and a statistical power of 80%. The study protocol was approved by the ethics committee of the hospital.

Be made prospectively followed subjects from study entry until catheter removal collecting information on age, sex, APACHEII, antibiotic therapy, duration of catheter insertion site and removal, reason for withdrawal and microbiological information.

For statistical analysis, a model is adjusted multivariate logistic regression, determining the interaction of variables with the likelihood ratio test and confusion by switching between the crude and adjusted effect greater than 10%.

Results and conclusions: The recruitment has started in November 2012 and is scheduled for completion in March 2013. This study will determine whether these new dressings are effective in our environment.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
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

入选标准

  • over 18 years, indicating the central intravascular catheter implantation in the ICU or in the operating room, prior informed consent -

排除标准

  • positive blood culture at the time of catheter implantation.

结局指标

主要结局

Incidence of intravascular central catheter colonization.

时间窗: November 2012- March 2013

次要结局

  • Adverse effects of CHG Tegaderm ® dressings.(up to 4 months)

研究者

发起方
Hospital Central de la Defensa Gómez Ulla
申办方类型
Other
责任方
Principal Investigator
主要研究者

ANA ISABEL LÓPEZ FIGUERAS

MD. Facultative of the Preventive Medicine Department

Hospital Central de la Defensa Gómez Ulla

研究点 (2)

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