Reducing Catheter-Related Bloodstream Infections in the ICU With a Chlorhexidine-Impregnated Sponge (BIOPATCH)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00548132
First received: October 22, 2007
Last updated: August 28, 2013
Last verified: August 2013
  Purpose

We proposed to perform a prospective randomized controlled trial to study the effect of the use of a commercially-available chlorhexidine-impregnated sponge (Biopatch) as part of central venous catheter care on catheter-related bloodstream infections among patients in two Barnes-Jewish Hospital ICUs.


Condition Intervention Phase
Catheter-related Bloodstream Infection
Device: Chlorhexidine-impregnated foam dressing
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Reducing Catheter-Related Bloodstream Infections in the ICU With a Chlorhexidine-Impregnated Sponge (BIOPATCH)

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • The Number of Catheter Related Bloodstream Infections (BSI) /1000 Catheter Days in Both Arms [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    The outcome measure is the number of episodes of bloodstream infections (BSI) divided by the catheter days at risk multiplied by 1000 for standardization


Secondary Outcome Measures:
  • Clinical Sepsis Episodes/Per 1000 Catheter Days [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    This measure is a combination of patients with positive blood cultures (BSI) and patients who had signs and symptoms of sepsis but with negative blood cultures. These patients still required treatment with antibiotics.


Enrollment: 1088
Study Start Date: February 2006
Study Completion Date: May 2009
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 1
Patients in this arm will continue to get routine care
Experimental: Chlorhexidine-impregnated foam dressing
Patient's catheters were cleaned with chlorhexidine-alcohol solution at least weekly before application of the Biopatch. These were evaluated daily and if the dressing was bloody, soiled or damaged, the dressing and the Biopatch were replaced prior to the 7-day period.
Device: Chlorhexidine-impregnated foam dressing
Patients in the treatment arm will have the Biopatch incorporated into their catheter care protocol. ICU nurses were instructed on the proper use of this novel dressing/sponge. Catheter dressing changes will only be done every 7 days unless there is visible blood, soiling underneath the dressing, or if the dressing comes off.
Other Name: Biopatch Antimicrobial Dressing

Detailed Description:

At the time of the inception of this study, there were no published randomized controlled trial on the efficacy of the Biopatch in reducing bloodstream infections. Preliminary data has shown that the Biopatch decreases colonization of the catheter exit site and thereby decrease bloodstream infections but this was at that time only theoretical.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients who are admitted to the ICU with a central venous catheter (i.e. triple lumen catheters, quadruple lumen catheters, percutaneously inserted central catheters, arterial catheters, intraaortic balloon pumps, Swan-Ganz catheters).

Exclusion Criteria:

  • patients who are not enrolled into the trial within 7 days of having the catheter being placed and patients who are allergic to chlorhexidine.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00548132

Locations
United States, Missouri
Barnes- Jewish Hospital
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Bernard C Camins, MD Washington University School of Medicine
  More Information

No publications provided

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00548132     History of Changes
Other Study ID Numbers: 00424-0805-01 (BJH Foundation), WUSM HRPO# 05-1186
Study First Received: October 22, 2007
Results First Received: June 12, 2013
Last Updated: August 28, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Chlorhexidine
Chlorhexidine gluconate
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Disinfectants
Dermatologic Agents

ClinicalTrials.gov processed this record on April 17, 2014