Clinical Trial: Chlorhexidine-Impregnated Sponge Dressing: A Clinical Trial

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

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 Coloniza

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 Summary:
Sponsor: University of Sao Paulo

Current Primary Outcome: 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With aseptic technique, the central venous catheter will be withdrawn and a 5 centimeters distal portion of the catheter will be cut and conditioned in sterile test tube and sent to the microbiology laboratory.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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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.


Original Secondary Outcome: Same as current

Information By: University of Sao Paulo

Dates:
Date Received: January 26, 2015
Date Started: April 2014
Date Completion: September 2016
Last Updated: May 11, 2016
Last Verified: May 2016