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

Study Overview
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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.

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

Conditions
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Catheter Related Bloodstream Infection

Intervention / Treatment
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* Device: Chlorhexidine-impregnated foam dressing


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: A<br>The patients in this arm continued with the local catheter care protocol. | Device: Chlorhexidine-impregnated foam dressing<br>* 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.<br>* Other names: Biopatch Antimicrobial Dressing;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Catheter-related bloodstream infection rate in bloodstream infections/1000 dialysis sessions |  | over a six-month period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bloodstream infections, hemodialysis catheter