Chlorhexidine-Impregnated Sponge Dressing: A Clinical Trial

Overview

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.

Full Title of Study: “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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: October 2015

Interventions

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

Arms, Groups and Cohorts

  • 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
  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Catheter Colonization
    • Time Frame: 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    • With aseptic technique, the central venous catheter will be withdrawn and a 5 centimeters distal portion of the catheter will be cut and conditioned in sterile test tube and sent to the microbiology laboratory.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 Measures

  • Microbiological Exit site Infection
    • Time Frame: 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
  • Clinical Exit Site Infection
    • Time Frame: 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.

Participating in This Clinical Trial

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;

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Sao Paulo
  • Provider of Information About this Clinical Study
    • Principal Investigator: Amanda Salles Margatho, PhD Student – University of Sao Paulo
  • Overall Official(s)
    • Amanda Salles Margatho, PhD student, Study Chair, University of São Paulo at Ribeirão Preto College of Nursing

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