Hydrocolloid Dressing for Catheter Exit Site Care in Peritoneal Dialysis Patients

Study of Hydrocolloid Dressing for Peritoneal Dialysis Catheter Exit Site Care in Peritoneal Dialysis Patients - a Pilot Study

The study aims to examine the use of hydrocolloid dressing for catheter exit-site care in peritoneal dialysis patients. It is a pilot study, and participants will be randomized to either receiving weekly hydrocolloid dressing or daily topical gentamicin cream for exit-site care in peritoneal dialysis patients.

Study Overview

• Status: Completed
• Conditions: Peritoneal Dialysis Catheter Exit Site Infection
• Intervention / Treatment: Device: hydrocolloid dressing; Drug: Gentamicin Sulfate, Topical

Detailed Description

Peritoneal dialysis (PD) related infection is one of the main reasons for patients to discontinue PD therapy. Routine exit-site care is crucial for the prevention of infections, however, daily antibiotics use has been associated with the risk of developing drug-resistant bacteria. Moreover, the burden of daily exit-site care can lead to non-compliance with treatment. Hydrocolloid dressing has been used in the management of acute and chronic wounds and is required to change once weekly, but its use has not been examined in the exit-site wound in PD patients.

The study primarily aims to examine PD-related infection (exit site infection or peritonitis rates) between patients using weekly hydrocolloid dressing (experimental group) and those using daily topical application of gentamicin (control group) for exit-site care in PD patients. Secondary aims include time to the first episode of PD-related infection, technique failure, PD infection-related hospitalization, and adverse events. The study will also assess the acceptability of dressing and quality of life between the two groups.

A total of 60 adult peritoneal dialysis patients will be recruited for the study. Patients will be randomly assigned to either the experimental group or the control group. Participants will be followed up at the 4th, 12th, and 24th week of study. The acceptability of the dressing will be assessed using the treatment acceptability questionnaires. The quality of life will be assessed using the ED 5D-5L questionnaires.

• Study Type: Interventional
• Enrollment (Actual): 60
• 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 and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• All adult peritoneal dialysis patients (≥ 21 years old) and are followed up at Singapore General Hospital (SGH)

Exclusion Criteria:

• Patients who are unable to provide valid consent, patients who have known allergy to hydrocolloid dressing, patients who have peritoneal dialysis catheter exit site infection or peritonitis within the past 3 months, patients who have dialysate leak at PD catheter exit site, pregnant women, patients with life-expectancy of < 1 year or patients who are currently involved in another study for peritoneal dialysis catheter exit site care.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hydrocolloid dressing; The intervention group will use the weekly hydrocolloid dressing (Duoderm Extra Thin CGF dressing,10 x 10 cm) for peritoneal dialysis exit-site care	Device: hydrocolloid dressing; Duoderm Extra Thin hydrocolloid dressing will be used to cover the catheter exit-site of participants in the intervention group. The dressing will be changed every 7 days or early if the dressing is no longer adhesive.
Active Comparator: Gentamicin cream; The control group will apply topical gentamicin cream to catheter exit site daily and cover with normal dressing	Drug: Gentamicin Sulfate, Topical; Application of gentamicin to exit site daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peritoneal dialysis (PD)-related infection rate	PD-related infection (exit-site /tunnel infection or peritonitis) (episode per patient-year)	24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to the first episode of exit-site/tunnel infection or peritonitis	Time to first episode of exit-site/tunnel infection or peritonitis (days)	24 weeks
Peritoneal dialysis infection-related hospitalization rate	Hospitalization due to peritoneal dialysis-related infection (episode per patient-year)	24 weeks
Technique failure rate	Technique failure is defined as transfer to hemodialysis for >= 30 days (episode per patient-year)	24 weeks
Adverse events	Adverse events related to the dressing (local or systemic effects)	24 weeks
Quality of life score using ED 5D 5L questionnaire	Quality of life score using ED 5D 5L questionnaire (numerical scores)	at 12th week of study
Treatment acceptability	Acceptability of dressing will be measured by treatment acceptability questionnaire	at 12th week of study

Collaborators and Investigators

• Sponsor: Singapore General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 11, 2022
• Primary Completion (Actual): July 30, 2025
• Study Completion (Actual): December 30, 2025

Study Registration Dates

• First Submitted: November 22, 2021
• First Submitted That Met QC Criteria: December 2, 2021
• First Posted (Actual): December 3, 2021

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 5, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: peritoneal dialysis; exit-site care; exit-site dressing
• Additional Relevant MeSH Terms: Carbohydrates; Glycosides; Equipment and Supplies; Aminoglycosides; Bandages; Gentamicins; Bandages, Hydrocolloid
• Other Study ID Numbers: 2021/2434

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

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