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

Singapore General Hospital50 enrolled

Overview

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

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

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Peritoneal Dialysis Catheter Exit Site Infection

Interventions

Chlorhexidine-impregnated diskDEVICE

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

Eligibility

Sex: ALLMin age: 21 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Locations (1)

Singapore General Hospital

Singapore, Singapore

Outcomes

Primary Outcomes

Exit-site/tunnel infection rate

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

Time frame: one year

Secondary Outcomes

Time to the first episode of exit-site/tunnel infection

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

Time frame: one year

peritonitis rate

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

Time frame: one year

time to first episode of peritonitis

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

Time frame: one year

Peritoneal dialysis infection-related hospitalization

Hospitalization due to peritoneal dialysis-related infection

Time frame: one year

technique failure rate

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

Time frame: one year

adverse events

any local or systemic adverse events

Time frame: one year

mortality

all-cause mortality

Time frame: one year

Data from ClinicalTrials.gov

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