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.

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Key information

Conditions

Catheter Related Bloodstream Infection Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Systemic Inflammatory Response Syndrome

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Barnes-Jewish Dialysis Center, St Louis, Missouri, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Patients who were allergic to chlorhexidine

Treatment and study plan

Chlorhexidine-impregnated foam dressing

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.

Other names: Biopatch Antimicrobial Dressing

Primary outcomes

Catheter-related bloodstream infection rate in bloodstream infections/1000 dialysis sessions

Time frame: over a six-month period

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Official study title

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

Important dates

Study start: 2004
Study completion: 2005
First posted: Oct 30, 2007
Registry last updated: Oct 30, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed