Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2012 by Hospital Central de la Defensa Gómez Ulla.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
ANA ISABEL LÓPEZ FIGUERAS, Hospital Central de la Defensa Gómez Ulla
ClinicalTrials.gov Identifier:
NCT01733940
First received: November 21, 2012
Last updated: November 27, 2012
Last verified: November 2012
  Purpose

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 Intervention Phase
Intravascular Catheter Colonization
Device: Application of a dressing with clorhexidine gluconate in intravascular catheters.
Device: Application of a dressing without clorhexidine gluconate
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Hospital Central de la Defensa Gómez Ulla:

Primary Outcome Measures:
  • Incidence of intravascular central catheter colonization. [ Time Frame: November 2012- March 2013 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Adverse effects of CHG Tegaderm ® dressings. [ Time Frame: up to 4 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 398
Study Start Date: September 2012
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01733940

Contacts
Contact: ana isabel lopez figueras, MD 0034911586958 ext 22958 alopfi1@oc.mde.es

Locations
Spain
Central Hospital of the Defense Recruiting
Madrid, Spain, 28047
Contact: ana isabel lopez figueras       alopfi1@oc.mde.es   
Principal Investigator: Ana isabel López figueras         
Sponsors and Collaborators
Hospital Central de la Defensa Gómez Ulla
  More Information

No publications provided

Responsible Party: ANA ISABEL LÓPEZ FIGUERAS, MD. Facultative of the Preventive Medicine Department, Hospital Central de la Defensa Gómez Ulla
ClinicalTrials.gov Identifier: NCT01733940     History of Changes
Other Study ID Numbers: 10/12
Study First Received: November 21, 2012
Last Updated: November 27, 2012
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios

ClinicalTrials.gov processed this record on November 24, 2014