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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-07

Study Completion Date

2019-10-25

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

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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.

Conditions

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Peritoneal Dialysis Catheter Exit Site Infection

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Prospective cohort study

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Chlorhexidine-impregnated disk

Intervention Type DEVICE

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

Interventions

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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

Intervention Type DEVICE

Other Intervention Names

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biopatch disk

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

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

Minimum Eligible Age

21 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No