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

Chlorhexidine-impregnated Sponge Dressing for Prevention of Catheter Exit Site Infection in Incident Peritoneal Dialysis Patients - a Pilot Study

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

Study Overview

• Status: Completed
• Conditions: Peritoneal Dialysis Catheter Exit Site Infection
• Intervention / Treatment: Device: Chlorhexidine-impregnated disk

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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 169856
    • Singapore General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exit-site/tunnel infection rate	Exit-site/tunnel infection rate (reported as episodes per patient-year) in patients receiving chlorhexidine-impregnated disk	one year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to the first episode of exit-site/tunnel infection	days from peritoneal dialysis initiation to the time develops first exit-site/tunnel infection	one year
peritonitis rate	Peritonitis rate (reported as episodes per patient-year) in patients receiving chlorhexidine-impregnated disk	one year
time to first episode of peritonitis	days from peritoneal dialysis initiation to the time develops first episode of peritonitis	one year
Peritoneal dialysis infection-related hospitalization	Hospitalization due to peritoneal dialysis-related infection	one year
technique failure rate	technique failure is defined as transfer to hemodialysis for >= 30 days	one year
adverse events	any local or systemic adverse events	one year
mortality	all-cause mortality	one year
patient satisfaction with the use of chlorhexidine-impregnated sponge dressing	Questionnaires related to the treatment with chlorhexidine-impregnated disk	third month of study
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	one year

Collaborators and Investigators

• Sponsor: Singapore General Hospital
• Collaborators: Johnson & Johnson
• Investigators: Principal Investigator: Htay Htay, Singapore General Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 7, 2018
• Primary Completion (Actual): October 1, 2019
• Study Completion (Actual): October 25, 2019

Study Registration Dates

• First Submitted: January 14, 2018
• First Submitted That Met QC Criteria: January 14, 2018
• First Posted (Actual): January 23, 2018

Study Record Updates

• Last Update Posted (Actual): March 23, 2020
• Last Update Submitted That Met QC Criteria: March 19, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: peritoneal dialysis; chlorhexidine; exit site infection; tunnel tract infection
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases; Anti-Infective Agents, Local; Anti-Infective Agents; Disinfectants; Chlorhexidine
• Other Study ID Numbers: SRG-NIG#08/2017

Drug and device information, study documents

• 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