Clinical trial NCT05143164: Hydrocolloid Dressing for Catheter Exit Site Care in Peritoneal Dialysis Patients
Official title: Study of Hydrocolloid Dressing for Peritoneal Dialysis Catheter Exit Site Care in Peritoneal Dialysis Patients - a Pilot Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Peritoneal Dialysis Catheter Exit Site Infection
Keywords: peritoneal dialysis
exit-site care
exit-site dressing
Lead sponsor: Singapore General Hospital
Sponsor class: OTHER
First posted: 2021-12-03
Enrollment: 60
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Peritoneal dialysis (PD)-related infection rate
timeFrame: 24 weeks
Secondary outcomes:
measure: Time to the first episode of exit-site/tunnel infection or peritonitis
timeFrame: 24 weeks
measure: Peritoneal dialysis infection-related hospitalization rate
timeFrame: 24 weeks
measure: Technique failure rate
timeFrame: 24 weeks
measure: Adverse events
timeFrame: 24 weeks
measure: Quality of life score using ED 5D 5L questionnaire
timeFrame: at 12th week of study
measure: Treatment acceptability
timeFrame: at 12th week of study
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Singapore General Hospital
Study officials:
References: