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

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.

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01733940
Acronym
EAC-UCI
Enrollment
398
Registered
2012-11-27
Start date
2012-09-30
Completion date
2013-06-30
Last updated
2012-11-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intravascular Catheter Colonization

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.

Interventions

DEVICEApplication of a dressing with clorhexidine gluconate in intravascular catheters.
DEVICEApplication of a dressing without clorhexidine gluconate

Sponsors

Hospital Central de la Defensa Gómez Ulla
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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. \-

Design outcomes

Primary

MeasureTime frame
Incidence of intravascular central catheter colonization.November 2012- March 2013

Secondary

MeasureTime frame
Adverse effects of CHG Tegaderm ® dressings.up to 4 months

Countries

Spain

Contacts

Primary Contactana isabel lopez figueras, MD
alopfi1@oc.mde.es0034911586958

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026