ClinicalTrials.Veeva

Menu

Trial Evaluating the Efficacy of a Chlorhexidine-Impregnated Sponge (BIOPATCH®) to Reduce Catheter-Related Bloodstream Infections in Hemodialysis Patients

The Washington University logo

The Washington University

Status and phase

Completed
Phase 4

Conditions

Catheter Related Bloodstream Infection

Treatments

Device: Chlorhexidine-impregnated foam dressing

Study type

Interventional

Funder types

Other

Identifiers

NCT00550693
WUSM HRPO 04-1312
Biopatch 400-05-005

Details and patient eligibility

About

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.

Enrollment

121 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • All patients who were dialyzed through a central venous catheter during the time period

Exclusion criteria

  • Patients who were allergic to chlorhexidine

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

121 participants in 1 patient group, including a placebo group

A
Placebo Comparator group
Description:
The patients in this arm continued with the local catheter care protocol.
Treatment:
Device: Chlorhexidine-impregnated foam dressing

Trial contacts and locations

2

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems