| Trial ID: | L1539 |
| Source ID: | NCT01996930
|
| Associated Drug: |
Haelan Tape (Steroid Impregnated Tape)
|
| Title: |
Steroid Impregnated Tape in the Treatment of Over-granulating Peritoneal Dialysis Exit Sites
|
| Acronym: |
STOP
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Peritoneal Dialysis|Continuous Ambulatory Peritoneal Dialysis|End Stage Renal Failure|Chronic Renal Failure
|
| Interventions: |
DRUG: Haelan tape (steroid impregnated tape)|DRUG: Silver Nitrate
|
| Outcome Measures: |
Primary: 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: Partial response rate of over-granulation to treatment, 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|Recurrence of over-granulation, 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., at 28 days and 56 days|Exit site infection rate, 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), within 28 days and 56 days|Exit site swab results, At defined time points the exit site will be swabbed by trained staff to detect the presence of micro-organisms, Baseline (Day 0), Day 7, Day 14, Day 21, Day 28 and Day 56|Patient reported pain, discomfort and satisfaction score, 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., Baseline (Day 0), Day 7, Day 14, Day 21, Day 28 and Day 56|Occurrence of redness, ulceration or infection using a standardised exit site assessment tool, 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
|
| Sponsor/Collaborators: |
Sponsor: University Hospital Birmingham NHS Foundation Trust
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
32
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2013-12
|
| Completion Date: |
2017-03
|
| Results First Posted: |
|
| Last Update Posted: |
2017-11-06
|
| Locations: |
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
|
| URL: |
https://clinicaltrials.gov/show/NCT01996930
|
