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

August 28, 2013 updated by: Washington University School of Medicine
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

1088

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Barnes- Jewish Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • Biopatch Antimicrobial Dressing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Investigators

  • Principal Investigator: Bernard C Camins, MD, Washington University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2006

Primary Completion (Actual)

February 1, 2008

Study Completion (Actual)

May 1, 2009

Study Registration Dates

First Submitted

October 22, 2007

First Submitted That Met QC Criteria

October 22, 2007

First Posted (Estimate)

October 23, 2007

Study Record Updates

Last Update Posted (Estimate)

September 12, 2013

Last Update Submitted That Met QC Criteria

August 28, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 00424-0805-01 (BJH Foundation)
  • WUSM HRPO# 05-1186

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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