A Pilot Evaluation Exploring New Adhesive Materials and Their Ability to Adhere to Abdominal and Peristomal Skin
Skin Abnormalities
About this trial
This is an interventional screening trial for Skin Abnormalities
Eligibility Criteria
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 exclusion criteria of this protocol
Sites / Locations
- Coloplast Research Unit/UserlabRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Other
Ostomy Adhesive material
comparator adhesive material
Newly designed ostomy adhesive material
Adhesive material already on the market e.g adhesive material from SenSura Mio ostomy product