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

NCT ID: NCT00548132

Last Updated: 2013-09-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 1088 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-02-28
• Study Completion Date: 2009-05-31

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.

Conditions

Catheter-related Bloodstream Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Patients in this arm will continue to get routine care

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Chlorhexidine-impregnated foam dressing

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

Biopatch Antimicrobial Dressing

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bernard C Camins, MD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

Barnes- Jewish Hospital

St Louis, Missouri, United States

Countries

United States

Other Identifiers

WUSM HRPO# 05-1186

Identifier Type: -

Identifier Source: secondary_id

00424-0805-01 (BJH Foundation)

Identifier Type: -

Identifier Source: org_study_id