Hydrocolloid Dressing for Catheter Exit Site Care in Peritoneal Dialysis Patients

Singapore Health Services (SingHealth)

Status: Active, not recruiting

Conditions: Peritoneal Dialysis Catheter Exit Site Infection

Treatments: Drug: Gentamicin Sulfate, Topical; Device: hydrocolloid dressing

Study type: Interventional

Funder types: Other

Identifiers

NCT05143164

2021/2434

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Hydrocolloid dressing

Experimental group

Description:

The intervention group will use the weekly hydrocolloid dressing (Duoderm Extra Thin CGF dressing,10 x 10 cm) for peritoneal dialysis exit-site care

Treatment:

Device: hydrocolloid dressing

Gentamicin cream

Active Comparator group

Description:

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

Treatment:

Drug: Gentamicin Sulfate, Topical