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

Phase 4

Completed

• Conditions: Catheter-related Bloodstream Infection
• Interventions: Device: Chlorhexidine-impregnated foam dressing

• Registration Number: NCT00548132
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2006-02
• Study First Submitted: 2007-10-22
• Study First Submitted QC: 2007-10-22
• Study First Posted: 2007-10-23
• Primary Completion: 2008-02
• Study Completion: 2009-05
• Results First Submitted: 2013-06-12
• Results First Submitted QC: 2013-06-12
• Status Verified: 2013-08
• Results First Posted: 2013-08-22
• Last Update Submitted: 2013-08-28
• Last Update Posted: 2013-09-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1088

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Chlorhexidine-impregnated foam dressing	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.

Primary Outcome Measures

Name	Time	Method
The Number of Catheter Related Bloodstream Infections (BSI) /1000 Catheter Days in Both Arms	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

Name	Time	Method
Clinical Sepsis Episodes/Per 1000 Catheter Days	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.

Trial Locations

Locations (1)

Barnes- Jewish Hospital; 🇺🇸 Saint Louis, Missouri, United States