Steroid tape to treat overgranulating peritoneal dialysis catheter exit sites
| ISRCTN | ISRCTN27017084 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN27017084 |
| EudraCT/CTIS number | 2013-003867-76 |
| ClinicalTrials.gov number | NCT01996930 |
| Secondary identifying numbers | 15417 |
- Submission date
- 08/01/2015
- Registration date
- 08/01/2015
- Last edited
- 20/05/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Plain English summary of protocol
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
Contact information
Scientific
Department of Primary Care & General Practice
Room 140
Primary Care Clinical Science Building
Edgbaston
Birmingham
B15 2TT
United Kingdom
Study information
| Study design | Randomised, interventional |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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 |
| Study objectives | 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(s) | 13/WM/0400 |
| Health condition(s) or problem(s) studied | Topic: Renal disorders; Subtopic: Renal disorders; Disease: All Renal disorders |
| Intervention | 1. Haelan tape 2. Steroid Impregnated tape |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Complete response rate in over-granulation severity; Timepoint(s): 14 days |
| Secondary outcome measures | N/A |
| Overall study start date | 01/12/2013 |
| Completion date | 30/08/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 80; UK Sample Size: 80 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/12/2013 |
| Date of final enrolment | 30/08/2016 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
B15 2TT
United Kingdom
Sponsor information
Hospital/treatment centre
Renal Department
Birmingham
B15 2TH
England
United Kingdom
"ROR" |
https://ror.org/014ja3n03 |
|---|
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | 28/08/2021 | 20/05/2022 | No | No | |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
20/05/2022: EU Clinical Trials Register results added.
16/04/2019: No publications found, verifying study status with principal investigator.
16/06/2016: Plain English summary added.
