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NCT05641168
A Pilot Evaluation Exploring New Adhesive Materials and Their Ability to Adhere to Abdominal and Peristomal Skin
Conditions: Skin Abnormalities
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: 1
Phase: NA
Enrollment: 400
Sponsor: Coloplast A/S
Location: Denmark
Summary
The study investigates different adhesive materials on healthy and peristomal skin
Eligibility Criteria
Inclusion Criteria:Has given written consentBe at least 18 years of age and have full legal capacityHave 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 chemotherapyCurrently receiving or have within the past month received topical steroid treatment in the abdominal skin area or systemic steroid (tablet/injection) treatmentAre pregnant or breastfeedingHaving 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
Source: ClinicalTrials.gov (NCT05641168). StuddyBuddy aggregates publicly available trial information.