Stoma Ileostomy
Conditions
Brief summary
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.
Interventions
DEVICECP381
All subjects will test the investigational device and the comparator for 6 hours during two different test days, with at least 14 days between the test days. Before the application of the investigational device as well as comparator, the stoma will be measured by the test personal and the baseplate will be pre-cut too big, leaving an approximately 5 mm distance from the edge of the hole in the baseplate to the stoma. The baseplates will be unique to each subject.
Sponsors
Coloplast A/S
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Has given written informed consent * Is at least 18 years old * Has full legal capacity * Has an ileostomy with consistent liquid faecal output (6-7 Bristol scale). * Has used flat SenSura Mio 1-piece or 2-piece for at least 14 days before the inclusion. * Has had the stoma for at least 90 days * Has a stoma size less than 45mm in diameter * Has experienced symptoms of peristomal skin complications such as itching, burning, or pain in the peristomal area within the last 14 days * Has suitable peristomal skin area (assessed by investigator) to participate in investigation * Is willing to refrain from analgesics within 24 hours before the test days * Is willing to refrain from antihistamine within 96 hours before the test days * Is willing to refrain from steroid treatment within 24 hours before the test days
Exclusion criteria
* Is currently receiving or have within the past 60 days received radio-and/or chemotherapy. * low doses radio- and/or chemotherapy (assessed by Principal Investigator) is allowed for other indications than cancer. * Is currently receiving or have within the past 30 days received topical steroid treatment in the peristomal skin area, e.g., lotion or spray. * Is breastfeeding * Is pregnant based on urine pregnancy test. * Has known hypersensitivity towards any of the devices used in the investigation. * Participates in other clinical investigations. Exception: Participation in other Coloplast sponsored clinical investigations is accepted under the circumstances that the subject has paused the activities in the investigation and are otherwise complying with the inclusion and
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum itching | 6 hours | Maximum itching score between hour 4-6 after application of the investigational device and the comparator (scale from 0-10) |
Countries
Denmark
Outcome results
None listed