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

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Intravascular Catheter Colonization

Intervention / Treatment
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* Device: Application of a dressing with clorhexidine gluconate in intravascular catheters.
* Device: Application of a dressing without clorhexidine gluconate


Participation Criteria
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Eligibility Criteria
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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. -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tegaderm CHG Dressing<br>This arm is receiving a clorhexidine dressing for intravascular catheters. | Device: Application of a dressing with clorhexidine gluconate in intravascular catheters.<br> <br> |
| Active Comparator: Tegaderm IV dressing<br>Use of tegaderm iv dressings for intravascular catheters. Change each 7 days. | Device: Application of a dressing without clorhexidine gluconate<br> <br> |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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