Intravascular Catheter Colonization Clinical Trial
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.
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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Prevention