Chlorhexidine-Impregnated Sponge Dressing: A Clinical Trial

Not Applicable

• Conditions: Catheter-Related Infections
• Interventions: Device: Polyurethane film dressing; Device: chlorhexidine-gel-impregnated dressing

• Registration Number: NCT02472158
• Lead Sponsor: University of Sao Paulo

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2015-01-26
• Study First Submitted QC: 2015-06-10
• Study First Posted: 2015-06-15
• Primary Completion: 2015-10
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-11
• Last Update Posted: 2016-05-13
• Study Completion: 2016-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Critically ill patients hospitalized carrying a short-term central venous catheter

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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;

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Polyurethane film dressing	Polyurethane film dressing	Polyurethane film dressing Patients receive a transparent polyurethane film dressing (3M Tegaderm IV dressing™) after insertion of central venous catheter.
chlorhexidine-gel-impregnated dressing	chlorhexidine-gel-impregnated dressing	Chlorhexidine Patients receive a chlorhexidine-gel-impregnated dressing ( 3M Tegaderm CHG IV securement dressing™ ) after insertion of central venous catheter

Primary Outcome Measures

Name	Time	Method
Catheter Colonization	Participants will be followed from placement until the withdraw of the central venous catheter, an expected average of 3 weeks.	With aseptic technique, the central venous catheter will be withdrawn and a 5 centimeters distal portion of the catheter will be cut and conditioned in sterile test tube and sent to the microbiology laboratory.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

Secondary Outcome Measures

Name	Time	Method
Clinical Exit Site Infection	Participants will be followed from placement until the withdraw of central venous catheter, an expected average of 3 weeks	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.
Microbiological Exit site Infection	Participants will be followed from placement until the withdraw of central venous catheter, an expected average of 3 weeks	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

Trial Locations

Locations (1)

Clinical Hospital of Ribeirão Preto Medical School (HCFMRP-USP); 🇧🇷 Ribeirão Preto, São Paulo, Brazil