Hydrocolloid Dressing for Catheter Exit Site Care in Peritoneal Dialysis Patients

NCT05143164 | Active Not Recruiting FDA Device

• 1 other identifier: 2021/2434
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Peritoneal Dialysis Catheter Exit Site Infection

Keywords

peritoneal dialysis; exit-site care; exit-site dressing

Outcome Measures

Primary Outcomes (1)

• Peritoneal dialysis (PD)-related infection rate

  PD-related infection (exit-site /tunnel infection or peritonitis) (episode per patient-year)

  24 weeks

Secondary Outcomes (6)

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

  24 weeks

• Peritoneal dialysis infection-related hospitalization rate

  24 weeks

• Technique failure rate

  24 weeks

• Adverse events

  24 weeks

• Quality of life score using ED 5D 5L questionnaire

  at 12th week of study

Study Arms (2)

Hydrocolloid dressing

EXPERIMENTAL

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

Gentamicin cream

ACTIVE COMPARATOR

The control group will apply topical gentamicin cream to catheter exit site daily and cover with normal dressing

Drug: Gentamicin Sulfate, Topical

Interventions

hydrocolloid dressing DEVICE

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.

Hydrocolloid dressing

Gentamicin Sulfate, Topical DRUG

Application of gentamicin to exit site daily

Gentamicin cream

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Singapore General Hospital: lead

Study Sites (1)

Singapore General Hospital

Singapore, 169856, Singapore

Location

MeSH Terms

Interventions

Bandages, Hydrocolloid; Gentamicins

Intervention Hierarchy (Ancestors)

Bandages; Equipment and Supplies; Aminoglycosides; Glycosides; Carbohydrates

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: November 22, 2021
• First Posted: December 3, 2021
• Study Start: March 11, 2022
• Primary Completion: June 30, 2024
• Study Completion: December 30, 2024
• Last Updated: May 1, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)