Skin Condition Clinical Trial
Official title:
An Open-labelled, Randomised, Controlled, Comparative, Multi-national, Cross-over Study Investigating the Safety and Performance of a New 2-piece Ostomy Product Compared to 2-piece Standard Care Ostomy Products
The primary object of this study is to provide clinical documentation for the New base plate
significantly 'reduces the degree of Leakage' under the base plate compared to Standard Care
base plates.
The secondary objectives are to provide clinical documentation on several performance and
safety parameters on the New base plate compared to Standard Care base plates.
The primary hypothesis is that the New base plate significantly reduces degree of leakage
under the base plate compared to Standard Care base plates.
Each test period will last for two weeks. In addition to this there will be one week run-in
period on New base plate. The data will be collected by investigator in the Case Report Form
at the inclusion visit, cross-over visit and termination visit. Data will also be collected
by the subject in a questionnaire during the two test periods.
The subjects will change their base plates on per need basis and continue with their normal
changing pattern in the entire study period.
100 subjects with ileostomy will be included in the study. The subjects will be recruited
from Europe including Denmark, Norway, Sweden, Iceland, Germany and France.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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