Efficacy of Tegaderm-CHG® Dressing vs. Tegaderm-IV® Dressing
NCT ID: NCT01733940
Last Updated: 2012-11-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
398 participants
INTERVENTIONAL
2012-09-30
2013-06-30
Brief Summary
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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
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
DOUBLE
Study Groups
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"Tegaderm CHG" Dressing
This arm is receiving a clorhexidine dressing for intravascular catheters.
Application of a dressing with clorhexidine gluconate in intravascular catheters.
"Tegaderm IV" dressing
Use of tegaderm iv dressings for intravascular catheters. Change each 7 days.
Application of a dressing without clorhexidine gluconate
Interventions
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Application of a dressing with clorhexidine gluconate in intravascular catheters.
Application of a dressing without clorhexidine gluconate
Eligibility Criteria
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Exclusion Criteria
18 Years
ALL
No
Sponsors
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Hospital Central de la Defensa Gómez Ulla
OTHER
Responsible Party
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ANA ISABEL LÓPEZ FIGUERAS
MD. Facultative of the Preventive Medicine Department
Locations
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Central Hospital of the Defense
Madrid, Madrid, Spain
Countries
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Central Contacts
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Facility Contacts
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ana isabel lopez figueras
Role: primary
Other Identifiers
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10/12
Identifier Type: -
Identifier Source: org_study_id