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

Hospital Central de la Defensa Gómez Ulla

Status and phase: Unknown; Phase 4

Conditions: Intravascular Catheter Colonization

Treatments: Device: Application of a dressing without clorhexidine gluconate; Device: Application of a dressing with clorhexidine gluconate in intravascular catheters.

Study type: Interventional

Funder types: Other

Identifiers

NCT01733940

10/12

Details and patient eligibility

About

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.

Enrollment: 398 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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398 participants in 2 patient groups

"Tegaderm CHG" Dressing

Experimental group

Description:

This arm is receiving a clorhexidine dressing for intravascular catheters.

Treatment:

Device: Application of a dressing with clorhexidine gluconate in intravascular catheters.

"Tegaderm IV" dressing

Active Comparator group

Description:

Use of tegaderm iv dressings for intravascular catheters. Change each 7 days.

Treatment:

Device: Application of a dressing without clorhexidine gluconate