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

Sponsor
Washington University School of Medicine (Other)
Overall Status
Completed
CT.gov ID
NCT00550693
Collaborator
(none)
121
Enrollment
2
Locations
1
Arm
11
Duration (Months)
60.5
Patients Per Site
5.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Chlorhexidine-impregnated foam dressing
 Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
121 participants
Allocation:
Non-Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Crossover Intervention Trial Evaluating the Efficacy of a Chlorhexidine-Impregnated Sponge (BIOPATCH®) to Reduce Catheter-Related Bloodstream Infections in Hemodialysis Patients
Study Start Date :
Apr 1, 2004
Actual Study Completion Date :
Mar 1, 2005

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: A

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.
Other Names:
  • Biopatch Antimicrobial Dressing

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Catheter-related bloodstream infection rate in bloodstream infections/1000 dialysis sessions [over a six-month period]

    Secondary Outcome Measures

    1. clinical sepsis rates between the two groups; exit site infection rates between the two groups; adverse events related to the intervention [over a 6 month period]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • All patients who were dialyzed through a central venous catheter during the time period
    Exclusion Criteria:
    • Patients who were allergic to chlorhexidine

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Barnes-Jewish Dialysis Center Saint Louis Missouri United States 63108
    2 Chromalloy American Kidney Center Saint Louis Missouri United States 63110

    Sponsors and Collaborators

    • Washington University School of Medicine

    Investigators

    • Principal Investigator: Bernard C Camins, MD, MSCR, Washington University School of Medicine

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00550693
    Other Study ID Numbers:
    • Biopatch 400-05-005
    • WUSM HRPO 04-1312
    First Posted:
    Oct 30, 2007
    Last Update Posted:
    Oct 30, 2007
    Last Verified:
    Oct 1, 2007
    Keywords provided by , ,
    bloodstream infections
    hemodialysis catheter
    Additional relevant MeSH terms:
    Infections
    Communicable Diseases
    Sepsis
    Chlorhexidine

    Study Results

    No Results Posted as of Oct 30, 2007