An Open-labelled, Randomised, Controlled, Comparative, Explorative, Cross-over Study Investigating Safety and Performance of a New 1-piece Ostomy Product Compared Standard Care Ostomy Products in Subjects With Ileostomy
N/A
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Leakage, Skin Condition
Both
Leakage, Skin Condition
Trial Information
An Open-labelled, Randomised, Controlled, Comparative, Explorative, Cross-over Study Investigating Safety and Performance of a New 1-piece Ostomy Product Compared Standard Care Ostomy Products in Subjects With Ileostomy
See brief summary
List of
Inclusion Criteria:
- Have given written informed consent.
- Are at least 18 years old.
- Have mental capacity to understand the study guidelines and questionnaires.
- Have had their ileostomy for at least 3 months
- Have an ileostomy with a diameter be-tween 19-40 mm.
- Are currently using a flat 1-piece product.
- Are able to change the product by them-selves or with help from a caregiver (e.g.
spouse)
- Have experienced leakage under the base plate at least once a week over the last 2
weeks.
List of Exclusion criteria.
- Pregnant or breast-feeding.
- Currently receiving or have within the past 2 months received radio- and/or
chemotherapy.
- Currently using topical steroid product on peristomal skin (injections and oral
treatment are accepted).
- Are currently using a convex product
- Participating in other clinical studies or have previously participated in this study
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Leakage underneath the baseplate
Outcome Time Frame:
two weeks
Safety Issue:
Yes
Principal Investigator
Carol Katte, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Ashford and St. Peters Hospital
Authority:
United Kingdom: National Institute for Health Research
Study ID:
CP214OC
NCT ID:
NCT01448629
Start Date:
May 2011
Completion Date:
July 2011
Related Keywords:
- Leakage
- Skin Condition
- Skin Diseases
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