Reducing Catheter-Related Bloodstream Infections in the ICU With a Chlorhexidine-Impregnated Sponge (BIOPATCH)
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|ClinicalTrials.gov Identifier: NCT00548132|
Recruitment Status : Completed
First Posted : October 23, 2007
Results First Posted : August 22, 2013
Last Update Posted : September 12, 2013
|Condition or disease||Intervention/treatment||Phase|
|Catheter-related Bloodstream Infection||Device: Chlorhexidine-impregnated foam dressing||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1088 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Reducing Catheter-Related Bloodstream Infections in the ICU With a Chlorhexidine-Impregnated Sponge (BIOPATCH)|
|Study Start Date :||February 2006|
|Actual Primary Completion Date :||February 2008|
|Actual Study Completion Date :||May 2009|
No Intervention: 1
Patients in this arm will continue to get routine care
Experimental: 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.
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.
Other Name: Biopatch Antimicrobial Dressing
- The Number of Catheter Related Bloodstream Infections (BSI) /1000 Catheter Days in Both Arms [ Time Frame: 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
- Clinical Sepsis Episodes/Per 1000 Catheter Days [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00548132
|United States, Missouri|
|Barnes- Jewish Hospital|
|Saint Louis, Missouri, United States, 63110|
|Principal Investigator:||Bernard C Camins, MD||Washington University School of Medicine|