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CISDCT: Chlorhexidine-Impregnated Sponge Dressing: A Clinical Trial

Sponsor
University of Sao Paulo (Other)
Overall Status
Unknown status
CT.gov ID
NCT02472158
Collaborator
(none)
120
Enrollment
1
Location
2
Arms
29
Duration (Months)
4.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: chlorhexidine-gel-impregnated dressing
  • Device: Polyurethane film dressing
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
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
Study Start Date :
Apr 1, 2014
Actual Primary Completion Date :
Oct 1, 2015
Anticipated Study Completion Date :
Sep 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: chlorhexidine-gel-impregnated dressing

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
Chlorhexidine Patients receive a chlorhexidine-gel-impregnated dressing ( 3M Tegaderm CHG IV securement dressing™ ) after insertion of central venous catheter
Other Names:
  • 3M Tegaderm CHG IV securement dressing™

    		•
    Active Comparator: Polyurethane film dressing

    Polyurethane film dressing Patients receive a transparent polyurethane film dressing (3M Tegaderm IV dressing™) after insertion of central venous catheter.

    Device: Polyurethane film dressing
    Polyurethane film dressing Patients receive a transparent polyurethane film dressing (3M Tegaderm IV dressing™) after insertion of central venous catheter.
    Other Names:
  • 3M Tegaderm IV dressing™

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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

    2. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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;

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Clinical Hospital of Ribeirão Preto Medical School (HCFMRP-USP) Ribeirão Preto São Paulo Brazil 14048-900

    Sponsors and Collaborators

    • University of Sao Paulo

    Investigators

    • Study Chair: Amanda Salles Margatho, PhD student, University of São Paulo at Ribeirão Preto College of Nursing

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Amanda Salles Margatho, PhD Student, University of Sao Paulo
    ClinicalTrials.gov Identifier:
    NCT02472158
    Other Study ID Numbers:
    • CISD-15
    First Posted:
    Jun 15, 2015
    Last Update Posted:
    May 13, 2016
    Last Verified:
    May 1, 2016
    Keywords provided by Amanda Salles Margatho, PhD Student, University of Sao Paulo
    Bandages
    Central Venous Catheters
    Catheter-Related Infections
    Additional relevant MeSH terms:
    Catheter-Related Infections
    Chlorhexidine

    Study Results

    No Results Posted as of May 13, 2016