- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01996930
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study will be a United Kingdom wide multi-centre trial. A minimum of 40 patients in each arm will be recruited. Subjects will be identified using a standardised exit site assessment tool by PD nurses in participating units during the routine care of their PD population. Any subject with an over-granulating exit site deemed to meet the agreed standard for treatment will be invited to participate.
Therapy will be administered for two weeks followed by an additional two weeks if clinically indicated. Treatment must be according to randomisation for the first 28 days. If after 14 days the over-granulation is worse than at day 0, then a medical decision to continue treatment may be taken. A further two weeks of the designated treatment may then be administered although this can be discontinued at any point if a satisfactory clinical response is observed.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
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Birmingham, United Kingdom, B15 2TH
- University Hospitals Birmingham NHS Foundation Trust
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Exeter, United Kingdom, EX2 5DW
- Royal Devon & Exeter NHS Foundation Trust
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Hull, United Kingdom, HU3 2JZ
- Hull and East Yorkshire Hospitals NHS Trust
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Leeds, United Kingdom, LS9 7TF
- Leeds Teaching Hospitals NHS Trust
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Liverpool, United Kingdom
- Royal Liverpool & Broadgreen University Hospitals NHS Trust
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Manchester, United Kingdom, M13 9WL
- Central Manchester University Hospitals NHS Foundation Trust
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Sheffield, United Kingdom
- Sheffield Teaching Hospitals NHS Foundation Trust
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Stoke on Trent, United Kingdom, ST4 6QG
- University Hospital Of North Staffordshire NHS Trust
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Haelan tape (steroid impregnated tape)
Haelan 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 |
Medicated plaster applied daily.
Max daily dose = 0.1mg (25cm squared per day)Maximum duration of treatment = 28 days
Other Names:
|
Active Comparator: Silver nitrate
Avoca caustic applicator 95% w/w cutaneous stick Cautery with silver nitrate cutaneous stick undertaken twice weekly Maximum duration of treatment = 28 days
|
Cautery with silver nitrate cutaneous stick undertaken twice weekly for a maximum duration of treatment = 28 days
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Complete response rate in over-granulation severity
Time Frame: 14 days
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Partial response rate of over-granulation to treatment
Time Frame: 14 days and 28 days
|
Partial response rate of over-granulation to treatment by either silver nitrate or steroid impregnated tape will assessed 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 and 28 days
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Recurrence of over-granulation
Time Frame: at 28 days and 56 days
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Following treatment, what is the rate of recurrence of over-granulation tissue at Day 28 and Day 56 of the study.
The local investigators will assess the exit site at protocol defined study visits using a standardised exit site assessment tool.
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at 28 days and 56 days
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Exit site infection rate
Time Frame: within 28 days and 56 days
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Following treatment, what is the rate of exit site infections within 28 and 56 days (An exit site infection is defined as occurring when a clinician decides treatment with antibiotics is required)
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within 28 days and 56 days
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Exit site swab results
Time Frame: Baseline (Day 0), Day 7, Day 14, Day 21, Day 28 and Day 56
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At defined time points the exit site will be swabbed by trained staff to detect the presence of micro-organisms
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Baseline (Day 0), Day 7, Day 14, Day 21, Day 28 and Day 56
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Patient reported pain, discomfort and satisfaction score
Time Frame: Baseline (Day 0), Day 7, Day 14, Day 21, Day 28 and Day 56
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The study will 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, through completion of a short non-validated patient questionnaire.
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Baseline (Day 0), Day 7, Day 14, Day 21, Day 28 and Day 56
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Occurrence of redness, ulceration or infection using a standardised exit site assessment tool
Time Frame: Baseline (Day 0), Day 7, Day 14, Day 21, Day 28, Day 56
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The local investigators will assess the exit site at protocol defined study visits using a standardised exit site assessment tool.
|
Baseline (Day 0), Day 7, Day 14, Day 21, Day 28, Day 56
|
Collaborators and Investigators
Investigators
- Principal Investigator: Lukas Foggensteiner, BM FRCP PhD, University Hospital Birmingham NHS Foundation Trust
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RRK 4249
- 2013-003867-76 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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