A Pilot Evaluation Exploring New Adhesive Materials and Their Ability to Adhere to Abdominal and Peristomal Skin
Not Applicable
Recruiting
- Conditions
- Skin Abnormalities
- Registration Number
- NCT05641168
- Lead Sponsor
- Coloplast A/S
- Brief Summary
The study investigates different adhesive materials on healthy and peristomal skin
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 400
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Adherent area At every material change throughout the study, an average of 1 week Adherent area (assessed by photos of adhesive materials)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Coloplast Research Unit/Userlab
🇩🇰Humlebaek, Denmark
Coloplast Research Unit/Userlab🇩🇰Humlebaek, DenmarkLene FeldskovContact+4549111888