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

NCT01733940 | Unknown Phase 4 DMC

• 1 other identifier: 10/12
• Study Type: interventional
• Target: 398
• Locations: 1 country
• Sites: 1

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.

Conditions

Intravascular Catheter Colonization

Outcome Measures

Primary Outcomes (1)

• Incidence of intravascular central catheter colonization.

  November 2012- March 2013

Secondary Outcomes (1)

• Adverse effects of CHG Tegaderm ® dressings.

  up to 4 months

Study Arms (2)

"Tegaderm CHG" Dressing

EXPERIMENTAL

This arm is receiving a clorhexidine dressing for intravascular catheters.

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

"Tegaderm IV" dressing

ACTIVE COMPARATOR

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

Device: Application of a dressing without clorhexidine gluconate

Interventions

Application of a dressing with clorhexidine gluconate in intravascular catheters. DEVICE

"Tegaderm CHG" Dressing

Application of a dressing without clorhexidine gluconate DEVICE

"Tegaderm IV" dressing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Hospital Central de la Defensa Gómez Ulla: lead

Study Sites (1)

Central Hospital of the Defense

Madrid, Madrid, 28047, Spain

RECRUITING

Central Study Contacts

ana isabel lopez figueras, MD

CONTACT

0034911586958; alopfi1@oc.mde.es

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD. Facultative of the Preventive Medicine Department

Study Record Dates

• First Submitted: November 21, 2012
• First Posted: November 27, 2012
• Study Start: September 1, 2012
• Primary Completion: March 1, 2013
• Study Completion: June 1, 2013
• Last Updated: November 28, 2012

Record last verified: 2012-11

Locations

ES (1)