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Sponsored by: |
Washington University School of Medicine |
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Information provided by: | Washington University School of Medicine |
ClinicalTrials.gov Identifier: | NCT00548132 |
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 |
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Catheter-Related Bloodstream Infection |
Device: Chlorhexidine-impregnated foam dressing Other: Standard Dressing |
Phase IV |
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) |
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 |
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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.
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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.
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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.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Missouri | |
Barnes- Jewish Hospital | |
Saint Louis, Missouri, United States, 63110 |
Principal Investigator: | Bernard C Camins, MD | Washington University School of Medicine |
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 |
Anti-Infective Agents, Local Disinfectants Chlorhexidine Chlorhexidine gluconate |
Anti-Infective Agents Anti-Infective Agents, Local Communicable Diseases Disinfectants Chlorhexidine |
Chlorhexidine gluconate Therapeutic Uses Infection Dermatologic Agents Pharmacologic Actions |