A Pilot Evaluation Exploring New Adhesive Materials and Their Ability to Adhere to Abdominal and Peristomal Skin
1 other identifier
interventional
114
1 country
1
Brief Summary
The study investigates different adhesive materials on healthy and peristomal skin
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2021
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 28, 2021
CompletedFirst Submitted
Initial submission to the registry
November 15, 2022
CompletedFirst Posted
Study publicly available on registry
December 7, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
May 30, 2024
CompletedSeptember 4, 2025
August 1, 2025
3.1 years
November 15, 2022
August 27, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Adherent area
Adherent area (assessed by photos of adhesive materials)
At every material change throughout the study, an average of 1 week
Study Arms (2)
Ostomy Adhesive material
EXPERIMENTALNewly designed ostomy adhesive material
comparator adhesive material
OTHERAdhesive material already on the market e.g adhesive material from SenSura Mio ostomy product
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Coloplast A/Slead
Study Sites (1)
Coloplast Research Unit/Userlab
Humlebæk, Denmark
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 15, 2022
First Posted
December 7, 2022
Study Start
April 28, 2021
Primary Completion
May 30, 2024
Study Completion
May 30, 2024
Last Updated
September 4, 2025
Record last verified: 2025-08