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Completed

NCT Number: NCT05143164

Hydrocolloid Dressing for Catheter Exit Site Care in Peritoneal Dialysis Patients

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.

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Key information

Conditions

Peritoneal Dialysis Catheter Exit Site Infection

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Singapore General Hospital

Singapore, 169856

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Gentamicin Sulfate, Topical

Drug

Application of gentamicin to exit site daily

Primary outcomes

  1. Peritoneal dialysis (PD)-related infection rate

    Time frame: 24 weeks

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

Secondary outcomes

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

    Time frame: 24 weeks

    Time to first episode of exit-site/tunnel infection or peritonitis (days)

  2. Peritoneal dialysis infection-related hospitalization rate

    Time frame: 24 weeks

    Hospitalization due to peritoneal dialysis-related infection (episode per patient-year)

  3. Technique failure rate

    Time frame: 24 weeks

    Technique failure is defined as transfer to hemodialysis for >= 30 days (episode per patient-year)

  4. Adverse events

    Time frame: 24 weeks

    Adverse events related to the dressing (local or systemic effects)

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

    Time frame: at 12th week of study

    Quality of life score using ED 5D 5L questionnaire (numerical scores)

  6. Treatment acceptability

    Time frame: at 12th week of study

    Acceptability of dressing will be measured by treatment acceptability questionnaire

Sponsors and collaborators

Lead sponsor

Singapore General Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Dec 3, 2021
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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