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

NCT ID: NCT00550693

Last Updated: 2007-10-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

121 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-04-30

Study Completion Date

2005-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Catheter Related Bloodstream Infection

Keywords

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bloodstream infections hemodialysis catheter

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

The patients in this arm continued with the local catheter care protocol.

Group Type PLACEBO_COMPARATOR

Chlorhexidine-impregnated foam dressing

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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Biopatch Antimicrobial Dressing

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Patients who were allergic to chlorhexidine
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Washington University School of Medicine

OTHER

Sponsor Role lead

Principal Investigators

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Bernard C Camins, MD, MSCR

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

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Barnes-Jewish Dialysis Center

St Louis, Missouri, United States

Site Status

Chromalloy American Kidney Center

St Louis, Missouri, United States

Site Status

Countries

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United States

Other Identifiers

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WUSM HRPO 04-1312

Identifier Type: -

Identifier Source: secondary_id

Biopatch 400-05-005

Identifier Type: -

Identifier Source: org_study_id