EAC-UCI: Efficacy of Tegaderm-CHG® Dressing vs. Tegaderm-IV® Dressing
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- Incidence of intravascular central catheter colonization. [November 2012- March 2013]
Secondary Outcome Measures
- Adverse effects of CHG Tegaderm ® dressings. [up to 4 months]
Eligibility Criteria
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.
-
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Central Hospital of the Defense | Madrid | Spain | 28047 |
Sponsors and Collaborators
- Hospital Central de la Defensa Gómez Ulla
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 10/12