Efficacy of Tegaderm-CHG® Dressing vs. Tegaderm-IV® Dressing (EAC-UCI)
Recruitment status was Recruiting
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.
Intravascular Catheter Colonization
Device: Application of a dressing with clorhexidine gluconate in intravascular catheters.
Device: Application of a dressing without clorhexidine gluconate
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||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.|
- Incidence of intravascular central catheter colonization. [ Time Frame: November 2012- March 2013 ] [ Designated as safety issue: Yes ]
- Adverse effects of CHG Tegaderm ® dressings. [ Time Frame: up to 4 months ] [ Designated as safety issue: Yes ]
|Study Start Date:||September 2012|
|Estimated Study Completion Date:||June 2013|
|Estimated Primary Completion Date:||March 2013 (Final data collection date for primary outcome measure)|
Experimental: "Tegaderm CHG" Dressing
This arm is receiving a clorhexidine dressing for intravascular catheters.
|Device: Application of a dressing with clorhexidine gluconate in intravascular catheters.|
Active Comparator: "Tegaderm IV" dressing
Use of tegaderm iv dressings for intravascular catheters. Change each 7 days.
|Device: Application of a dressing without clorhexidine gluconate|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01733940
|Contact: ana isabel lopez figueras, MD||0034911586958 ext email@example.com|
|Central Hospital of the Defense||Recruiting|
|Madrid, Spain, 28047|
|Contact: ana isabel lopez figueras firstname.lastname@example.org|
|Principal Investigator: Ana isabel López figueras|