A randomised, controlled trial to compare the safety and effectiveness of steroid tape with silver nitrate therapy, the current standard treatment for patients who have over-granulating tissue of their periotoneal dialysis catheter exit site.

Phase 1

• Conditions: Over-granulation of peritoneal dialysis exit site in patients with End Stage Renal Failure; MedDRA version: 18.0 Level: PT Classification code 10034660 Term: Peritoneal dialysis System Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 18.0 Level: LLT Classification code 10008831 Term: Chronic ambulatory peritoneal dialysis System Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 18.0 Level: LLT Classification code 10067974 Term: Automated peritoneal dialysis System Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 18.0 Level: PT Classification code 10067594 Term: Peritoneal dialysis complication System Organ Class: 10022117 - Injury, poisoning and procedural complications; MedDRA version: 18.0 Level: LLT Classification code 10064116 Term: Continuous ambulatory peritoneal dialysis System Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Body processes [G] - Biological Phenomena [G16]

• Registration Number: EUCTR2013-003867-76-GB
• Lead Sponsor: niversity Hospitals Birmingham NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-09-26
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 80

Inclusion Criteria

Inclusion criteria;

•Subject has been established on Peritoneal Dialysis for > 3 months
•Subject has an over-granulating exit site judged to require treatment according to standard
•If patient has exit site infection, they must currently be treated with antibiotics and the site must be clinically improving.
•Subject is > 18 years of age
•Subject is able to give informed consent

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

Exclusion criteria;

•Subject has had peritonitis treated in the previous month
•Subject has been treated with silver nitrate or topical steroids in the previous 2 weeks
•Subject is receiving oral steroids
•Patient is unable to give informed consent
•Patient is participating in a clinical trial of an intervention relating to PD catheters.
•Subject is pregnant or unwilling to use an effective method of contraception during the course of the study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified