Phase 4
N=1,088
Reducing Catheter-Related Bloodstream Infections in the ICU With a Chlorhexidine-Impregnated Sponge (BIOPATCH)
Catheter-related Bloodstream Infection
Bottom Line
View on ClinicalTrials.gov: NCT00548132 ↗Enrolled (actual)
1,088
Serious AEs
0.0%
Results posted
Aug 2013
Primary outcome: Primary: The Number of Catheter Related Bloodstream Infections (BSI) /1000 Catheter Days in Both Arms — 4.74; 4.72 BSIs /1000 catheter days — p=0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Chlorhexidine-impregnated foam dressing (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Washington University School of Medicine
- Primary completion
- Feb 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Number of Catheter Related Bloodstream Infections (BSI) /1000 Catheter Days in Both Arms |
4.74; 4.72 | 0.05 |
| SECONDARY Clinical Sepsis Episodes/Per 1000 Catheter Days |
7.8; 8.5 | — |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00548132). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.