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

Not Applicable

Completed

• Conditions: Peritoneal Dialysis Catheter Exit Site Infection
• Interventions: Device: Chlorhexidine-impregnated disk

• Registration Number: NCT03406520
• Lead Sponsor: Singapore General Hospital

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.

Study Timeline

• Study First Submitted: 2018-01-14
• Study First Submitted QC: 2018-01-14
• Study First Posted: 2018-01-23
• Study Start: 2018-03-07
• Primary Completion: 2019-10-01
• Study Completion: 2019-10-25
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-19
• Last Update Posted: 2020-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Chlorhexidine-impregnated disk	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

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (1)

Singapore General Hospital; 🇸🇬 Singapore, Singapore