Peristomal skin complications (PSCs) are the predominant complication for people living with a stoma, which affect their quality of life negatively. Among the main reasons for developing PSCs are that the peristomal skin is exposed to stomal output either due to leakage of output under the baseplate and/or imperfect cutting of the hole in the baseplate, and incorrect application creating a gap between the hole in the baseplate and the stoma. To seal this gap, Coloplast has developed a new ostomy baseplate and the aim of the investigation is to explore the investigational device 's ability to help protect the peristomal skin.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
4 weeks treatment with investigational device
4 weeks treatment with comparator
Coloplast A/S
Humlebæk, Denmark
Maximum itching scale 0-10)
Itching score (weekly max at steady state\* scale 0-10). \* To account for a possible carry-over effect, the steady state period of the treatment period begins after two weeks of investigational device or comparator use. It is anticipated that the skin will have adapted to the new device after two weeks.
Time frame: 8 weeks
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