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

NCT00548132 | Completed Phase 4 Results DMC

• 2 other identifiers: 00424-0805-01 (BJH Foundation)WUSM HRPO# 05-1186
• Study Type: interventional
• Target: 1,088
• Locations: 1 country
• Sites: 1

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.

Conditions

Catheter-related Bloodstream Infection

Outcome Measures

Primary Outcomes (1)

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

  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 Outcomes (1)

• Clinical Sepsis Episodes/Per 1000 Catheter Days

  2 years

Study Arms (2)

1

NO INTERVENTION

Patients in this arm will continue to get routine care

Chlorhexidine-impregnated foam dressing

EXPERIMENTAL

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

Interventions

Chlorhexidine-impregnated foam dressing 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.

Also known as: Biopatch Antimicrobial Dressing

Chlorhexidine-impregnated foam dressing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• patients who are not enrolled into the trial within 7 days of having the catheter being placed and patients who are allergic to chlorhexidine.

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Barnes- Jewish Hospital

St Louis, Missouri, 63110, United States

Location

Results Point of Contact

• Title: Bernard C. Camins, MD
• Organization: Washington University School of Medicine

bcamins@dom.wustl.edu

3144548351

Study Officials

• Bernard C Camins, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2007
• First Posted: October 23, 2007
• Study Start: February 1, 2006
• Primary Completion: February 1, 2008
• Study Completion: May 1, 2009
• Last Updated: September 12, 2013
• Results First Posted: August 22, 2013

Record last verified: 2013-08

Locations

US (1)