Skin Abnormalities Clinical Trial
Official title:
A Pilot Evaluation Exploring New Adhesive Materials and Their Ability to Adhere to Abdominal and Peristomal Skin
NCT number | NCT05641168 |
Other study ID # | CP333 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | April 28, 2021 |
Est. completion date | August 1, 2023 |
The study investigates different adhesive materials on healthy and peristomal skin
Status | Recruiting |
Enrollment | 400 |
Est. completion date | August 1, 2023 |
Est. primary completion date | July 1, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Denmark | Coloplast Research Unit/Userlab | Humlebaek |
Lead Sponsor | Collaborator |
---|---|
Coloplast A/S |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Adherent area | Adherent area (assessed by photos of adhesive materials) | At every material change throughout the study, an average of 1 week |
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