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

Catheter Related Bloodstream Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00550693
• Other study ID #: Biopatch 400-05-005
• Secondary ID: WUSM HRPO 04-131
• Status: Completed
• Phase: Phase 4
• First received: October 29, 2007
• Last updated: October 29, 2007
• Start date: April 2004
• Est. completion date: March 2005

Study information

• Verified date: October 2007
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: March 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Catheter Related Bloodstream Infection
• Communicable Diseases
• Infection

Intervention

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.

Locations

Country	Name	City	State
United States	Barnes-Jewish Dialysis Center	Saint Louis	Missouri
United States	Chromalloy American Kidney Center	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Catheter-related bloodstream infection rate in bloodstream infections/1000 dialysis sessions		over a six-month period
Secondary	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