Hydrocolloid Dressing for Catheter Exit Site Care in Peritoneal Dialysis Patients

Not Applicable

Active, not recruiting

• Conditions: Peritoneal Dialysis Catheter Exit Site Infection
• Interventions: Drug: Gentamicin Sulfate, Topical; Device: hydrocolloid dressing

• Registration Number: NCT05143164
• Lead Sponsor: Singapore General Hospital

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.

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 Timeline

• Study First Submitted: 2021-11-22
• Study First Submitted QC: 2021-12-02
• Study First Posted: 2021-12-03
• Study Start: 2022-03-11
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-29
• Last Update Posted: 2024-05-01
• Primary Completion: 2024-06-30
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Gentamicin cream	Gentamicin Sulfate, Topical	The control group will apply topical gentamicin cream to catheter exit site daily and cover with normal dressing
Hydrocolloid dressing	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

Primary Outcome Measures

Name	Time	Method
Peritoneal dialysis (PD)-related infection rate	24 weeks	PD-related infection (exit-site /tunnel infection or peritonitis) (episode per patient-year)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Singapore General Hospital; 🇸🇬 Singapore, Singapore