The aim of the investigation was to investigate the performance and safety of a new ostomy product
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
38
Newly developed 1-piece convex ostomy product
The subjects Own product is used as baseline performance in this investigation. The products are commercial and available on the market, and are products manufactured by manufactures who produce convex ostomy products i.e. Coloplast, Convatec, Dansac, B.Braun, Hollister and more.
A commercially available soft convex product
TFS
Søborg, Denmark
Degree of Leakage
The degree of leakage is investigated on a 32-point scale (including 0 for no leakage). O represents no leakage and 32 represents the worst leakage.
Time frame: 14 +/- 3 days
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