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.

A prospective, randomised controlled trial to determine the safety and efficacy of steroid impregnated tape compared to standard therapy with silver nitrate in the treatment of over-granulating peritoneal dialysis catheter exit sites - Steroid tape to treat overgranulating PD exit sites

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-003867-76-GB

Enrollment

Registered

2013-09-26

Start date

2013-11-07

Completion date

Unknown

Last updated

2019-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

Interventions

Trade Name: Haelan Tape Product Name: NA Product Code: NA Pharmaceutical Form: Medicated plaster INN or Proposed INN: Fludroxycortide

Eligibility

Sex/Gender

All

Inclusion criteria

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: 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

Design outcomes

Primary

Measure	Time frame
Timepoint(s) of evaluation of this end point: The primary endpoint will be complete response rate in over-granulation severity at 14 days, as assessed by inspection of sequential photographs of the exit site by two independent observers blinded to designated randomised treatment arm.; Main Objective: A complication of peritoneal dialysis can be over-granulation of the tissue surrounding the point where the peritoneal dialysis catheter exits the abdomen. This over-granulation tissue appears red, bumpy and inflamed. This tissue is often also painful and can easily become infected. The principal research objective of this study is to assess the total response at 14 days to treatment with either steroid impregnated tape (Haelan tape) or silver nitrate therapy on the over-granulated tissue. ; Secondary Objective: The secondary research questions/objectives of this study are: 1) If the treatment has not completely resolved the over-granulation, leaving the tissue surrounding the exit site healthy, what is the partial response to the treatment the patient received. The partial response to treatment will be assessed at Day 14 and Day 28. 2) Following treatment, what is the rate of recurrence of over-granulation tissue at Days 28 and Day 56 of the study. 3) Following treatment, what is the rate of exit site infections within 28 & 56 days. (An Exit site infection is defined as occurring when a clinician decides treatment with antibiotics is required) 4)Exit site swab results. At defined time-points the exit site will be swabbed by trained staff to detect the presence of micro-organisms 5) The study will also assess patient reported pain and discomfort, as well as satisfaction, in terms of convenience and ease of use, with the treatment they received to treat their over-granulation tissue. 6) ;	—

Measure

Time frame

Timepoint(s) of evaluation of this end point: The primary endpoint will be complete response rate in over-granulation severity at 14 days, as assessed by inspection of sequential photographs of the exit site by two independent observers blinded to designated randomised treatment arm.; Main Objective: A complication of peritoneal dialysis can be over-granulation of the tissue surrounding the point where the peritoneal dialysis catheter exits the abdomen. This over-granulation tissue appears red, bumpy and inflamed. This tissue is often also painful and can easily become infected. The principal research objective of this study is to assess the total response at 14 days to treatment with either steroid impregnated tape (Haelan tape) or silver nitrate therapy on the over-granulated tissue. ; Secondary Objective: The secondary research questions/objectives of this study are: 1) If the treatment has not completely resolved the over-granulation, leaving the tissue surrounding the exit site healthy, what is the partial response to the treatment the patient received. The partial response to treatment will be assessed at Day 14 and Day 28. 2) Following treatment, what is the rate of recurrence of over-granulation tissue at Days 28 and Day 56 of the study. 3) Following treatment, what is the rate of exit site infections within 28 & 56 days. (An Exit site infection is defined as occurring when a clinician decides treatment with antibiotics is required) 4)Exit site swab results. At defined time-points the exit site will be swabbed by trained staff to detect the presence of micro-organisms 5) The study will also assess patient reported pain and discomfort, as well as satisfaction, in terms of convenience and ease of use, with the treatment they received to treat their over-granulation tissue. 6) ;

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Secondary

Measure	Time frame
Secondary end point(s): Secondary endpoints will be: 1. Partial response rate of over-granulation to treatment 2. Recurrence of over-granulation 3. Exit site infections 4. Exit site swab results 5. Patient reported pain, discomfort and satisfaction score 6. Occurrence of redness, ulceration or infection using a standardised exit site assessment tool ; Timepoint(s) of evaluation of this end point: Secondary endpoints will be evaluated at the following time points: 1. Partial response rate of over-granulation to treatment at 14 and 28 days 2. Recurrence of over-granulation within 28 and 56 days 3. Exit site infections within 28 and 56 days 4. Exit site swab results following swabs taken at day 0, 7, 14, 21, 28 and 56 5. Patient reported pain, discomfort and satisfaction score at visits at day 0, 7, 14, 21, 28 and 56 6. Occurrence of redness, ulceration or infection using a standardised exit site assessment tool at visits at day 0, 7, 14, 21, 28 and 56	—

Measure

Time frame

Secondary end point(s): Secondary endpoints will be: 1. Partial response rate of over-granulation to treatment 2. Recurrence of over-granulation 3. Exit site infections 4. Exit site swab results 5. Patient reported pain, discomfort and satisfaction score 6. Occurrence of redness, ulceration or infection using a standardised exit site assessment tool ; Timepoint(s) of evaluation of this end point: Secondary endpoints will be evaluated at the following time points: 1. Partial response rate of over-granulation to treatment at 14 and 28 days 2. Recurrence of over-granulation within 28 and 56 days 3. Exit site infections within 28 and 56 days 4. Exit site swab results following swabs taken at day 0, 7, 14, 21, 28 and 56 5. Patient reported pain, discomfort and satisfaction score at visits at day 0, 7, 14, 21, 28 and 56 6. Occurrence of redness, ulceration or infection using a standardised exit site assessment tool at visits at day 0, 7, 14, 21, 28 and 56

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Countries

United Kingdom

Contacts

Public ContactNicola Anderson

University Hospitals Birmingham NHS Foundation Trust

nicola.anderson@uhb.nhs.uk07769648885

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026