- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00550693
Trial Evaluating the Efficacy of a Chlorhexidine-Impregnated Sponge (BIOPATCH®) to Reduce Catheter-Related Bloodstream Infections in Hemodialysis Patients
A Crossover Intervention Trial Evaluating the Efficacy of a Chlorhexidine-Impregnated Sponge (BIOPATCH®) to Reduce Catheter-Related Bloodstream Infections in Hemodialysis Patients
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Missouri
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Saint Louis, Missouri, United States, 63108
- Barnes-Jewish Dialysis Center
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Saint Louis, Missouri, United States, 63110
- Chromalloy American Kidney Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- All patients who were dialyzed through a central venous catheter during the time period
Exclusion Criteria:
- Patients who were allergic to chlorhexidine
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: A
The patients in this arm continued with the local catheter care protocol.
|
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:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Catheter-related bloodstream infection rate in bloodstream infections/1000 dialysis sessions
Time Frame: over a six-month period
|
over a six-month period
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
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over a 6 month period
|
Collaborators and Investigators
Investigators
- Principal Investigator: Bernard C Camins, MD, MSCR, Washington University School of Medicine
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Biopatch 400-05-005
- WUSM HRPO 04-1312
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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