A Phase 4 interventional study of Chlorhexidine-impregnated foam dressing in Catheter Related Bloodstream Infection, sponsored by Washington University School of Medicine. Completed at 2 sites in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2007-10-30.
Sponsored by Washington University School of Medicine · Phase 4, Interventional, and Treatment
There are currently no published data on the efficacy of the chlorhexidine-impregnated foam dressing to reduce catheter-related bloodstream infections (BSI) in hemodialysis patients.
The researchers perfomed a cross-over intervention trial on patients who were dialyzed through central venous catheters at two outpatient dialysis centers were enrolled. The use of a chlorhexidine-impregnated foam dressing was incorporated into the catheter care protocol during the intervention period. A nested cohort study of all patients who received the foam dressing was also conducted to determine independent risk factors for development of BSI.
The primary outcomes were the catheter-related bloodstream infection rates in the intervention and control groups. Secondary outcomes include the clinical sepsis rates between the two groups and risk factors for development of bloodstream infection despite the use of the foam dressing.
6,688 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 121 is close to the median of 120 across 4,201 interventional studies indexed under Infections.
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Of its 324 completed or terminated interventional studies of FDA-regulated products, 212 (65%) have results posted.
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Exclusion Criteria:
The patients in this arm continued with the local catheter care protocol.
Device: Chlorhexidine-impregnated foam dressing
Patients during the intervention period had this foam dressing applied around their central venous catheter. This was replaced once a week as recommended by the package insert unless the dressing was soiled, bloody, or fell off.
Also known as: Biopatch Antimicrobial Dressing
Catheter-related bloodstream infection rate in bloodstream infections/1000 dialysis sessions
Time frame: over a six-month period
clinical sepsis rates between the two groups; exit site infection rates between the two groups; adverse events related to the intervention
Time frame: over a 6 month period
This study is completed, as verified in Oct 2007. You cannot join it, but the record below documents what was studied.
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Washington University School of Medicine