The influence of the baseplate adhesive type, shape and application is investigated with regard to the degree of leakage.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
22
Coloplast Test A is a newly developed ostomy appliance
Coloplast Test B is a newly developed ostomy appliance.
Standard product is the subjects usual product. Only subjects that usually use the CE-marked commercially available SenSura 1-piece flat and SenSura Mio 1-piece are included in the investigation.
Coloplast A/S
Humlebæk, Denmark
Degree of Leakage
The primary endpoint was the degree of leakage under the baseplate, which was assessed using the three innermost rings of the 32-point leakage scale, corresponding to a total of 24 points (0 indicating no leakage and 24 indicating maximum leakage). Results are given separately for subjects with colostomy and ileostomy. In the ileostomy group there were no SenSura Mio participants in the standard care group.
Time frame: 10 (- 2 days)
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