Hydrocolloid Dressing for Catheter Exit Site Care in Peritoneal Dialysis Patients

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Peritoneal Dialysis Catheter Exit Site Infection

Intervention / Treatment
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* Device: hydrocolloid dressing
* Drug: Gentamicin Sulfate, Topical


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hydrocolloid dressing<br>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<br>* 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.<br>|
| Active Comparator: Gentamicin cream<br>The control group will apply topical gentamicin cream to catheter exit site daily and cover with normal dressing | Drug: Gentamicin Sulfate, Topical<br>* Application of gentamicin to exit site daily<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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peritoneal dialysis, exit-site care, exit-site dressing