Skin Abnormalities
Conditions
Brief summary
The study investigates different adhesive materials on healthy and peristomal skin
Interventions
OTHERAdhesive material
Newly developed adhesive material
OTHERStandard adhesive material
Standard adhesive material
Sponsors
Coloplast A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Has given written consent * Be at least 18 years of age and have full legal capacity * Have had a colostomy/ileostomy/urostomy for more than one year (for stoma patients) Have suitable peristomal skin area (assessed by investigator) (for stoma patients)
Exclusion criteria
* Currently receiving or have within the past 2 months received radio- and/or chemotherapy * Currently receiving or have within the past month received topical steroid treatment in the abdominal skin area or systemic steroid (tablet/injection) treatment * Are pregnant or breastfeeding * Having dermatological problems in the abdominal area (assessed by investigator) * Participate 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 |
|---|---|---|
| Adherent area | At every material change throughout the study, an average of 1 week | Adherent area (assessed by photos of adhesive materials) |
Countries
Denmark
Outcome results
None listed