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

Sponsored by:	Washington University School of Medicine
Information provided by:	Washington University School of Medicine
ClinicalTrials.gov Identifier:	NCT00548132

Purpose

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	Intervention	Phase
Catheter-Related Bloodstream Infection	Device: Chlorhexidine-impregnated foam dressing Other: Standard Dressing	Phase IV

Drug Information available for: Chlorhexidine Chlorhexidine digluconate Hibiclens

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Reducing Catheter-Related Bloodstream Infections in the ICU With a Chlorhexidine-Impregnated Sponge (BIOPATCH)

Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:

The primary outcome for this study is the number of catheter related infections measured in bloodstream infections/1000 catheter days in both arms [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Secondary outcomes will include the rates of clinical sepsis per 1000 catheter days and the proportion of patients discontinuing the intervention because of adverse events [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	700
Study Start Date:	February 2006
Estimated Study Completion Date:	May 2009
Primary Completion Date:	February 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: No Intervention Patients in this arm will continue to get the standard catheter care protocol without the use of the chlorhexidine-impregnated foam dressing.	Other: Standard Dressing Patients in the placebo arm will continue to get the standard catheter care protocol without the use of the chlorhexidine-impregnated foam dressing.
Chlorhexidine-impregnated foam dressing: Experimental	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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00548132

Locations

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

Sponsors and Collaborators

Washington University School of Medicine

Investigators

Principal Investigator:

Bernard C Camins, MD

Washington University School of Medicine

More Information

No publications provided

Responsible Party:	Washington University ( Bernard Camins, MD )
Study ID Numbers:	00424-0805-01 (BJH Foundation), WUSM HRPO# 05-1186
Study First Received:	October 22, 2007
Last Updated:	April 13, 2009
ClinicalTrials.gov Identifier:	NCT00548132 History of Changes
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Anti-Infective Agents, Local
Disinfectants
Chlorhexidine
Chlorhexidine gluconate

Additional relevant MeSH terms:

Anti-Infective Agents
Anti-Infective Agents, Local
Communicable Diseases
Disinfectants
Chlorhexidine

Chlorhexidine gluconate
Therapeutic Uses
Infection
Dermatologic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009