Reducing Catheter-Related Bloodstream Infections in the ICU With a Chlorhexidine-Impregnated Sponge (BIOPATCH)
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Enrollment
- 1,088
- Locations
- 1
- Primary Endpoint
- The Number of Catheter Related Bloodstream Infections (BSI) /1000 Catheter Days in Both Arms
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
1
Patients in this arm will continue to get routine care
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.
Intervention: Chlorhexidine-impregnated foam dressing (Device)
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Clinical Sepsis Episodes/Per 1000 Catheter Days(2 years)