Hydrocolloid Dressing for Catheter Exit Site Care in Peritoneal Dialysis Patients

Peritoneal Dialysis Catheter Exit Site Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05143164
• Other study ID #: 2021/2434
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 11, 2022
• Est. completion date: December 30, 2024

Study information

• Verified date: April 2024
• Source: Singapore General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: December 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Peritoneal Dialysis Catheter Exit Site Infection

Intervention

Device:
• hydrocolloid dressing
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.

Drug:
• Gentamicin Sulfate, Topical
Application of gentamicin to exit site daily

Locations

Country	Name	City	State
Singapore	Singapore General Hospital	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Singapore General Hospital

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peritoneal dialysis (PD)-related infection rate	PD-related infection (exit-site /tunnel infection or peritonitis) (episode per patient-year)	24 weeks
Secondary	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
Secondary	Peritoneal dialysis infection-related hospitalization rate	Hospitalization due to peritoneal dialysis-related infection (episode per patient-year)	24 weeks
Secondary	Technique failure rate	Technique failure is defined as transfer to hemodialysis for >= 30 days (episode per patient-year)	24 weeks
Secondary	Adverse events	Adverse events related to the dressing (local or systemic effects)	24 weeks
Secondary	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
Secondary	Treatment acceptability	Acceptability of dressing will be measured by treatment acceptability questionnaire	at 12th week of study