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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Peritoneal Dialysis Catheter Exit Site Infection

Intervention / Treatment
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* Device: Chlorhexidine-impregnated disk


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Interventional Model Description: Prospective cohort study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chlorhexidine-impregnated disk<br>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<br>* 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<br>* Other names: biopatch disk;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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peritoneal dialysis, chlorhexidine, exit site infection, tunnel tract infection