A Pilot Evaluation Exploring New Adhesive Materials and Their Ability to Adhere to Abdominal and Peristomal Skin
NCT ID: NCT05641168
Last Updated: 2025-09-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
114 participants
INTERVENTIONAL
2021-04-28
2024-05-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SCREENING
NONE
Study Groups
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Ostomy Adhesive material
Newly designed ostomy adhesive material
Adhesive material
Newly developed adhesive material
comparator adhesive material
Adhesive material already on the market e.g adhesive material from SenSura Mio ostomy product
Standard adhesive material
Standard adhesive material
Interventions
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Adhesive material
Newly developed adhesive material
Standard adhesive material
Standard adhesive material
Eligibility Criteria
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Inclusion Criteria
* 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 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)
18 Years
ALL
Yes
Sponsors
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Coloplast A/S
INDUSTRY
Responsible Party
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Locations
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Coloplast Research Unit/Userlab
Humlebæk, , Denmark
Countries
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Other Identifiers
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CP333
Identifier Type: -
Identifier Source: org_study_id
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