Chlorhexidine-Impregnated Sponge Dressing: A Clinical Trial

Study Overview
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Brief Summary
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The purpose of this study is to compare the use of chlorhexidine-gel-impregnated dressing and the transparent polyurethane film dressing as coverage of the site of insertion of central venous catheter, in the evaluation of catheter colonization in critically ill adults patients.

Official Title
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Use of Chlorhexidine-gel-Impregnated Dressing Compared to Transparent Polyurethane Film Dressing as Coverage of the Site of Insertion of Central Venous Catheter, in the Evaluation of Catheter Colonization in Critically Ill Adults Patients: A Randomized Controlled Trial

Conditions
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Catheter-Related Infections

Intervention / Treatment
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* Device: chlorhexidine-gel-impregnated dressing
* Device: Polyurethane film dressing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Critically ill patients hospitalized carrying a short-term central venous catheter Exclusion Criteria: Use of a central venous catheter with antimicrobial coating Suspected or confirmed bacterial infection at randomization Known allergic/hypersensitivity reaction to any compounds of the treatment Active lesions in the skin where the CVC is located and / or where the dressing of CVC is being conducted;

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: chlorhexidine-gel-impregnated dressing<br>Chlorhexidine Patients receive a chlorhexidine-gel-impregnated dressing ( 3M Tegaderm CHG IV securement dressing™ ) after insertion of central venous catheter | Device: chlorhexidine-gel-impregnated dressing<br>* Chlorhexidine Patients receive a chlorhexidine-gel-impregnated dressing ( 3M Tegaderm CHG IV securement dressing™ ) after insertion of central venous catheter<br>* Other names: 3M Tegaderm CHG IV securement dressing™;|
| Active Comparator: Polyurethane film dressing<br>Polyurethane film dressing Patients receive a transparent polyurethane film dressing (3M Tegaderm IV dressing™) after insertion of central venous catheter. | Device: Polyurethane film dressing<br>* Polyurethane film dressing Patients receive a transparent polyurethane film dressing (3M Tegaderm IV dressing™) after insertion of central venous catheter.<br>* Other names: 3M Tegaderm IV dressing™;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Catheter Colonization | With aseptic technique, the central venous catheter will be withdrawn and a 5 centimeters distal portion of the catheter will be cut and conditioned in sterile test tube and sent to the microbiology laboratory. It will be considered a Catheter Colonization a significant growth of one or more microorganism in a semiquantitative culture of the catheter tip. It is according to the Clinical Practice Guidelines for the Diagnosis and management of Intravascular Catheter- Related Infection: 2009 Update by the Infectious Diseases Society of America | Participants will be followed from placement until the withdraw of the central venous catheter, an expected average of 3 weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Microbiological Exit site Infection | With aseptic technique, a swab will be collected before removal of central venous catheter, the swab will be moistened with sterile saline and rolled for about 2 cm around the exit site. The material will be conditioned in sterile test tube and sent to the microbiology laboratory. It will be considered a Microbiological Exit Site Infection the exudate at catheter exit site yields a microorganism. According to Clinical Practice Guideline for Diagnosis and Management of intravascular Catheter-Related Infection: 2009 Update by the Infectious Diseases Society of America | Participants will be followed from placement until the withdraw of central venous catheter, an expected average of 3 weeks | 
| Clinical Exit Site Infection | Erythema, induration, and/or tenderness within 2 cm of the catheter exit site, according to Clinical Practice Guidelines for the diagnosis and management of intravascular Catheter-Related Infection: 2009 Update by the infectious diseases Society of America. | Participants will be followed from placement until the withdraw of central venous catheter, an expected average of 3 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bandages, Central Venous Catheters, Catheter-Related Infections