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Chlorhexidine Disk for Prevention of Exit-site Infection in Peritoneal Dialysis Patients

Sponsor
Singapore General Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03406520
Collaborator
Johnson & Johnson (Industry)
50
Enrollment
1
Location
1
Arm
19.6
Actual Duration (Months)
2.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of the study is to evaluate the efficacy and safety of chlorhexidine-impregnated disk in preventing catheter exit-site infection in peritoneal dialysis patients

Condition or Disease Intervention/Treatment Phase
  • Device: Chlorhexidine-impregnated disk
 N/A

Detailed Description

The primary aim of the study is to examine the exit-site infection rate in patients using chlorhexidine-impregnated dressing.

The participant will be followed up at 2, 6, 12, 24, 36 and 52 weeks of study and during each visit the catheter exit-site will be examined by one of the investigators for any sign of infection or allergic reaction, and questionnaires about satisfaction with use of study material (biopatch) will be asked by a study team member at the 12 week visit of the study. Each participant will be followed up for one year.

Study Design

Study Type:
Interventional
Actual Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Prospective cohort studyProspective cohort study
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Chlorhexidine-impregnated Sponge Dressing for Prevention of Catheter Exit Site Infection in Incident Peritoneal Dialysis Patients - a Pilot Study
Actual Study Start Date :
Mar 7, 2018
Actual Primary Completion Date :
Oct 1, 2019
Actual Study Completion Date :
Oct 25, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Chlorhexidine-impregnated disk

The chlorhexidine-impregnated disk, will be applied to the peritoneal dialysis catheter exit-site and the disk will be changed once a week

Device: Chlorhexidine-impregnated disk
The chlorhexidine-impregnated sponge, named biopatch, is a protective disk (2.5 cm x 0.7 cm), which is hydrophilic polyurethane absorptive foam with chlorhexidine gluconate, in average of 86.8mg per disk
Other Names:
  • biopatch disk

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Exit-site/tunnel infection rate [one year]

      Exit-site/tunnel infection rate (reported as episodes per patient-year) in patients receiving chlorhexidine-impregnated disk

    Secondary Outcome Measures

    1. Time to the first episode of exit-site/tunnel infection [one year]

      days from peritoneal dialysis initiation to the time develops first exit-site/tunnel infection

    2. peritonitis rate [one year]

      Peritonitis rate (reported as episodes per patient-year) in patients receiving chlorhexidine-impregnated disk

    3. time to first episode of peritonitis [one year]

      days from peritoneal dialysis initiation to the time develops first episode of peritonitis

    4. Peritoneal dialysis infection-related hospitalization [one year]

      Hospitalization due to peritoneal dialysis-related infection

    5. technique failure rate [one year]

      technique failure is defined as transfer to hemodialysis for >= 30 days

    6. adverse events [one year]

      any local or systemic adverse events

    7. mortality [one year]

      all-cause mortality

    8. patient satisfaction with the use of chlorhexidine-impregnated sponge dressing [third month of study]

      Questionnaires related to the treatment with chlorhexidine-impregnated disk

    9. comparison of the above outcomes with historical cohort using topical antibiotics cream [one year]

      comparison of exit-site/tunnel infection rate, peritonitis rate, time to first episode of exit-site/tunnel infection or peritonitis, technique failure rate, hospitalization rate, adverse events, mortality with historical cohort patients using topical gentamicin cream

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • All adult incident peritoneal dialysis patients between 21 to 90 years old, who are followed up in Singapore General Hospital
    Exclusion Criteria:

    1. patients who have known history of allergy to chlorhexidine

    2. patients who had previous history of peritoneal dialysis catheter exit-site infection

    3. patients with mentally challenging conditions who are unable to give the valid consent for the study

    4. patients who have been involved in another study for exit site infection

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Singapore General Hospital Singapore Singapore 169856

    Sponsors and Collaborators

    • Singapore General Hospital
    • Johnson & Johnson

    Investigators

    • Principal Investigator: Htay Htay, Singapore General Hospital

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Singapore General Hospital
    ClinicalTrials.gov Identifier:
    NCT03406520
    Other Study ID Numbers:
    • SRG-NIG#08/2017
    First Posted:
    Jan 23, 2018
    Last Update Posted:
    Mar 23, 2020
    Last Verified:
    Mar 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Product Manufactured in and Exported from the U.S.:
    Yes
    Keywords provided by Singapore General Hospital
    peritoneal dialysis
    chlorhexidine
    exit site infection
    tunnel tract infection
    Additional relevant MeSH terms:
    Infections
    Communicable Diseases
    Chlorhexidine

    Study Results

    No Results Posted as of Mar 23, 2020