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

Primary Purpose

Peritoneal Dialysis Catheter Exit Site Infection

Status
Completed
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
Chlorhexidine-impregnated disk
Sponsored by
Singapore General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Peritoneal Dialysis Catheter Exit Site Infection focused on measuring peritoneal dialysis, chlorhexidine, exit site infection, tunnel tract infection

Eligibility Criteria

21 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Singapore General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Chlorhexidine-impregnated disk

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Time to the first episode of exit-site/tunnel infection
days from peritoneal dialysis initiation to the time develops first exit-site/tunnel infection
peritonitis rate
Peritonitis rate (reported as episodes per patient-year) in patients receiving chlorhexidine-impregnated disk
time to first episode of peritonitis
days from peritoneal dialysis initiation to the time develops first episode of peritonitis
Peritoneal dialysis infection-related hospitalization
Hospitalization due to peritoneal dialysis-related infection
technique failure rate
technique failure is defined as transfer to hemodialysis for >= 30 days
adverse events
any local or systemic adverse events
mortality
all-cause mortality
patient satisfaction with the use of chlorhexidine-impregnated sponge dressing
Questionnaires related to the treatment with chlorhexidine-impregnated disk
comparison of the above outcomes with historical cohort using topical antibiotics cream
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

Full Information

First Posted
January 14, 2018
Last Updated
March 19, 2020
Sponsor
Singapore General Hospital
Collaborators
Johnson & Johnson
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1. Study Identification

Unique Protocol Identification Number
NCT03406520
Brief Title
Chlorhexidine Disk for Prevention of Exit-site Infection in Peritoneal Dialysis Patients
Official Title
Chlorhexidine-impregnated Sponge Dressing for Prevention of Catheter Exit Site Infection in Incident Peritoneal Dialysis Patients - a Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
March 7, 2018 (Actual)
Primary Completion Date
October 1, 2019 (Actual)
Study Completion Date
October 25, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Singapore General Hospital
Collaborators
Johnson & Johnson

4. Oversight

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
Data Monitoring Committee
No

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peritoneal Dialysis Catheter Exit Site Infection
Keywords
peritoneal dialysis, chlorhexidine, exit site infection, tunnel tract infection

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Prospective cohort study
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Chlorhexidine-impregnated disk
Arm Type
Experimental
Arm Description
The chlorhexidine-impregnated disk, will be applied to the peritoneal dialysis catheter exit-site and the disk will be changed once a week
Intervention Type
Device
Intervention Name(s)
Chlorhexidine-impregnated disk
Other Intervention Name(s)
biopatch disk
Intervention Description
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
Primary Outcome Measure Information:
Title
Exit-site/tunnel infection rate
Description
Exit-site/tunnel infection rate (reported as episodes per patient-year) in patients receiving chlorhexidine-impregnated disk
Time Frame
one year
Secondary Outcome Measure Information:
Title
Time to the first episode of exit-site/tunnel infection
Description
days from peritoneal dialysis initiation to the time develops first exit-site/tunnel infection
Time Frame
one year
Title
peritonitis rate
Description
Peritonitis rate (reported as episodes per patient-year) in patients receiving chlorhexidine-impregnated disk
Time Frame
one year
Title
time to first episode of peritonitis
Description
days from peritoneal dialysis initiation to the time develops first episode of peritonitis
Time Frame
one year
Title
Peritoneal dialysis infection-related hospitalization
Description
Hospitalization due to peritoneal dialysis-related infection
Time Frame
one year
Title
technique failure rate
Description
technique failure is defined as transfer to hemodialysis for >= 30 days
Time Frame
one year
Title
adverse events
Description
any local or systemic adverse events
Time Frame
one year
Title
mortality
Description
all-cause mortality
Time Frame
one year
Title
patient satisfaction with the use of chlorhexidine-impregnated sponge dressing
Description
Questionnaires related to the treatment with chlorhexidine-impregnated disk
Time Frame
third month of study
Title
comparison of the above outcomes with historical cohort using topical antibiotics cream
Description
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
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All adult incident peritoneal dialysis patients between 21 to 90 years old, who are followed up in Singapore General Hospital Exclusion Criteria: patients who have known history of allergy to chlorhexidine patients who had previous history of peritoneal dialysis catheter exit-site infection patients with mentally challenging conditions who are unable to give the valid consent for the study patients who have been involved in another study for exit site infection
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Htay Htay
Organizational Affiliation
Singapore General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Singapore General Hospital
City
Singapore
ZIP/Postal Code
169856
Country
Singapore

12. IPD Sharing Statement

Citations:
PubMed Identifier
33025409
Citation
Htay H, Choo JCJ, Johnson DW, Pascoe EM, Jayaballa M, Oei EL, Ng LC, Wu SY, Foo MWY. Chlorhexidine-impregnated sponge dressing for prevention of catheter exit-site infection in peritoneal dialysis patients: a pilot study. Int Urol Nephrol. 2021 Apr;53(4):803-812. doi: 10.1007/s11255-020-02674-w. Epub 2020 Oct 6.
Results Reference
derived

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

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