Condition category
Urological and Genital Diseases
Date applied
08/01/2015
Date assigned
08/01/2015
Last edited
16/06/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Kidney failure is a devastating illness where the kidneys no longer function properly, requiring treatment with dialysis or transplantation to preserve life. Patients unable to have transplants are managed by peritoneal dialysis or haemodialysis. Peritoneal dialysis involves the placement of a soft, flexible plastic tube (catheter) into the abdomen, allowing dialysis fluid to be drained in and out of the peritoneal cavity, in order to remove waste products from the blood. The catheter exits from a hole in the abdomen and occasionally patients can have complications at this exit site. One possible complication is overgranulation. Overgranulation occurs as the wound attempts to heal and the skin around the exit site becomes red, ‘wet’, ‘bumpy’ and stands ‘proud’ of the surrounding skin. An overgranulating exit site can lead to discomfort, pain, bleeding and harbour infection. More serious complications include dialysis failure, sepsis and death. There are several ways to treat overgranulation but there is limited research evidence to demonstrate which treatment is best. The aim of this study is to determine the safety and effectiveness of steroid-impregnated tape compared to standard treatment with silver nitrate.

Who can participate?
Patients aged over 18 on peritoneal dialysis who have an overgranulating exit site

What does the study involve?
Participants are randomly allocated to receive either the current standard treatment, which involves the application of silver nitrate by qualified nursing staff to chemically burn the tissue away, or an alternative treatment which involves the patient themselves applying a steroid-impregnated tape. The severity of over-granulation is assessed after 14 days.

What are the possible benefits and risks of participating?
Not provided at time of registration

Where is the study run from?
University Hospital Birmingham NHS Foundation Trust (UK)

When is the study starting and how long is it expected to run for?
December 2013 to August 2016

Who is funding the study?
National Institute for Health Research (UK)

Who is the main contact?
Nicola Anderson

Trial website

Contact information

Type

Scientific

Primary contact

Mrs Nicola Anderson

ORCID ID

Contact details

Department of Primary Care & General Practice
Room 140
Primary Care Clinical Science Building
Edgbaston
Birmingham
B15 2TT
United Kingdom

Additional identifiers

EudraCT number

2013-003867-76

ClinicalTrials.gov number

NCT01996930

Protocol/serial number

15417

Study information

Scientific title

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 overgranulating peritoneal dialysis catheter exit sites

Acronym

Study hypothesis

There are several ways to treat overgranulation but there is limited research evidence to demonstrate which treatment is best. The study aims to compare current standard treatment which involves the application of silver nitrate by qualified nursing staff to chemically burn the tissue away, with an alternative treatment which involves the application of a steroid impregnated tape by the patient themselves.

Ethics approval

13/WM/0400

Study design

Randomised, interventional

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Topic: Renal disorders; Subtopic: Renal disorders; Disease: All Renal disorders

Intervention

1. Haelan tape
2. Steroid Impregnated tape

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measures

Complete response rate in over-granulation severity; Timepoint(s): 14 days

Secondary outcome measures

N/A

Overall trial start date

01/12/2013

Overall trial end date

30/08/2016

Reason abandoned

Eligibility

Participant inclusion criteria

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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 80; UK Sample Size: 80

Participant exclusion criteria

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

Recruitment start date

01/12/2013

Recruitment end date

30/08/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Primary Care & General Practice
Birmingham
B15 2TT
United Kingdom

Sponsor information

Organisation

University Hospital Birmingham NHS Foundation Trust

Sponsor details

Renal Department
Birmingham
B15 2TH
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

16/06/2016: Plain English summary added.