Efficacy of Tegaderm-CHG® Dressing vs. Tegaderm-IV® Dressing

Phase 4

• Conditions: Intravascular Catheter Colonization
• Interventions: Device: Application of a dressing with clorhexidine gluconate in intravascular catheters.; Device: Application of a dressing without clorhexidine gluconate

• Registration Number: NCT01733940
• Lead Sponsor: Hospital Central de la Defensa Gómez Ulla

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09
• Status Verified: 2012-11
• Study First Submitted: 2012-11-21
• Study First Submitted QC: 2012-11-21
• Study First Posted: 2012-11-27
• Last Update Submitted: 2012-11-27
• Last Update Posted: 2012-11-28
• Primary Completion: 2013-03
• Study Completion: 2013-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 398

Inclusion Criteria

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

Exclusion Criteria

positive blood culture at the time of catheter implantation.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
"Tegaderm CHG" Dressing	Application of a dressing with clorhexidine gluconate in intravascular catheters.	This arm is receiving a clorhexidine dressing for intravascular catheters.
"Tegaderm IV" dressing	Application of a dressing without clorhexidine gluconate	Use of tegaderm iv dressings for intravascular catheters. Change each 7 days.

Primary Outcome Measures

Name	Time	Method
Incidence of intravascular central catheter colonization.	November 2012- March 2013

Secondary Outcome Measures

Name	Time	Method
Adverse effects of CHG Tegaderm ® dressings.	up to 4 months

Trial Locations

Locations (1)

Central Hospital of the Defense; 🇪🇸 Madrid, Spain