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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00548132
Recruitment Status : Completed
First Posted : October 23, 2007
Results First Posted : August 22, 2013
Last Update Posted : September 12, 2013
Information provided by (Responsible Party):
Washington University School of Medicine

Brief Summary:
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 or disease Intervention/treatment Phase
Catheter-related Bloodstream Infection Device: Chlorhexidine-impregnated foam dressing Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1088 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Reducing Catheter-Related Bloodstream Infections in the ICU With a Chlorhexidine-Impregnated Sponge (BIOPATCH)
Study Start Date : February 2006
Actual Primary Completion Date : February 2008
Actual Study Completion Date : May 2009

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. The Number of Catheter Related Bloodstream Infections (BSI) /1000 Catheter Days in Both Arms [ Time Frame: 2 years ]
    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 :
  1. Clinical Sepsis Episodes/Per 1000 Catheter Days [ Time Frame: 2 years ]
    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.

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00548132

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

Responsible Party: Washington University School of Medicine Identifier: NCT00548132     History of Changes
Other Study ID Numbers: 00424-0805-01 (BJH Foundation)
WUSM HRPO# 05-1186
First Posted: October 23, 2007    Key Record Dates
Results First Posted: August 22, 2013
Last Update Posted: September 12, 2013
Last Verified: August 2013

Additional relevant MeSH terms:
Communicable Diseases
Chlorhexidine gluconate
Anti-Infective Agents, Local
Anti-Infective Agents
Dermatologic Agents