Steroid Impregnated Tape in the Treatment of Over-granulating Peritoneal Dialysis Exit Sites
STOP
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
2 other identifiers
interventional
32
1 country
8
Brief Summary
Kidney failure is a devastating illness requiring treatment with dialysis or transplantation to preserve life. Individuals unable to have transplants are managed by peritoneal dialysis (PD)or haemodialysis (HD). PD 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. This catheter exits from a hole in the abdomen and occasionally patients can have complications at this exit site. One possible complication is over-granulation. Over-granulation 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 over-granulating 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 over-granulation 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 steroid impregnated tape to the area of over-granulating tissue by the patient themselves.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Dec 2013
Typical duration for phase_3
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 21, 2013
CompletedFirst Posted
Study publicly available on registry
November 27, 2013
CompletedStudy Start
First participant enrolled
December 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2017
CompletedNovember 6, 2017
October 1, 2017
3.2 years
November 21, 2013
October 31, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Complete response rate in over-granulation severity
The primary research objective of this study is to assess the total response at 14 days to treatment with either steroid tape or silver nitrate therapy on the over-granulated tissue surrounding the PD exit site. Assessment is by two blinded independent investigators (patient and therapy administrators will not be blinded to the therapy received). At each of the study visits, a series of photographs will be taken according to a study specific standard operating procedure and the two assessors will score the exit sites from the photographic series. There is no standardised scoring system for over-granulating exit sites so a scale has been devised: Score 1: Complete response:complete disappearance of over-granulation Score 2: Partial response: reduction in size or an obvious reduction in intensity of over-granulation Score 3: No change, appearance identical to that of pre-treatment Score 4: Worse, increase in size or increased intensity of over-granulation
14 days
Secondary Outcomes (6)
Partial response rate of over-granulation to treatment
14 days and 28 days
Recurrence of over-granulation
at 28 days and 56 days
Exit site infection rate
within 28 days and 56 days
Exit site swab results
Baseline (Day 0), Day 7, Day 14, Day 21, Day 28 and Day 56
Patient reported pain, discomfort and satisfaction score
Baseline (Day 0), Day 7, Day 14, Day 21, Day 28 and Day 56
- +1 more secondary outcomes
Study Arms (2)
Haelan tape (steroid impregnated tape)
ACTIVE COMPARATORHaelan tape, medicated tape for cutaneous use, containing 4mcg Fludroxycortide per centimetre squared. Maximum daily dosage of 0.1mg = 25cm squared per day. Application = once daily and left in situ for 24 hours Maximum duration of treatment = 28 days
Silver nitrate
ACTIVE COMPARATORAvoca caustic applicator 95% w/w cutaneous stick Cautery with silver nitrate cutaneous stick undertaken twice weekly Maximum duration of treatment = 28 days
Interventions
Medicated plaster applied daily. Max daily dose = 0.1mg (25cm squared per day)Maximum duration of treatment = 28 days
Cautery with silver nitrate cutaneous stick undertaken twice weekly for a maximum duration of treatment = 28 days
Eligibility Criteria
You may qualify if:
- Subject has been established on PD for \> 3 months
- Subject has an over-granulating exit site judged to require treatment according to standard (appendix 1)
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
University Hospitals Birmingham NHS Foundation Trust
Birmingham, B15 2TH, United Kingdom
Royal Devon & Exeter NHS Foundation Trust
Exeter, EX2 5DW, United Kingdom
Hull and East Yorkshire Hospitals NHS Trust
Hull, HU3 2JZ, United Kingdom
Leeds Teaching Hospitals NHS Trust
Leeds, LS9 7TF, United Kingdom
Royal Liverpool & Broadgreen University Hospitals NHS Trust
Liverpool, United Kingdom
Central Manchester University Hospitals NHS Foundation Trust
Manchester, M13 9WL, United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, United Kingdom
University Hospital of North Staffordshire NHS Trust
Stoke-on-Trent, ST4 6QG, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lukas Foggensteiner, BM FRCP PhD
University Hospital Birmingham NHS Foundation Trust
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Consultant Nephrologist
Study Record Dates
First Submitted
November 21, 2013
First Posted
November 27, 2013
Study Start
December 1, 2013
Primary Completion
March 1, 2017
Study Completion
March 1, 2017
Last Updated
November 6, 2017
Record last verified: 2017-10
Data Sharing
- IPD Sharing
- Will not share