Efficacy of Tegaderm-CHG® Dressing vs. Tegaderm-IV® Dressing (EAC-UCI)

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.

Study Overview

• Status: Unknown
• Conditions: Intravascular Catheter Colonization
• Intervention / Treatment: Device: Application of a dressing with clorhexidine gluconate in intravascular catheters.; Device: Application of a dressing without clorhexidine gluconate

• Study Type: Interventional
• Enrollment (Anticipated): 398
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: ana isabel lopez figueras, MD; Phone Number: 22958 0034911586958; Email: alopfi1@oc.mde.es

Study Locations

• Spain
  • Madrid, Spain, 28047
    • Recruiting
    • Central Hospital of the Defense
    • Contact: ana isabel lopez figueras; Email: alopfi1@oc.mde.es
    • Principal Investigator: Ana isabel López figueras

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of intravascular central catheter colonization.	November 2012- March 2013

Secondary Outcome Measures

Outcome Measure	Time Frame
Adverse effects of CHG Tegaderm ® dressings.	up to 4 months

Collaborators and Investigators

• Sponsor: Hospital Central de la Defensa Gómez Ulla

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Anticipated): March 1, 2013
• Study Completion (Anticipated): June 1, 2013

Study Registration Dates

• First Submitted: November 21, 2012
• First Submitted That Met QC Criteria: November 21, 2012
• First Posted (Estimate): November 27, 2012

Study Record Updates

• Last Update Posted (Estimate): November 28, 2012
• Last Update Submitted That Met QC Criteria: November 27, 2012
• Last Verified: November 1, 2012

More Information

Terms related to this study

• Other Study ID Numbers: 10/12