N/A
N=36
Evaluation of the Peel Force of New Adhesives From the Skin
Stoma Ileostomy
Bottom Line
View on ClinicalTrials.gov: NCT03200444 ↗Enrolled (actual)
36
Serious AEs
0.0%
Results posted
Apr 2025
Primary outcome: Primary: Peel Force — 5.2; 3; 2.1; 3.3 Newton
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Standard adhesive 1 (Other); Standard adhesive 2 (Other); Standard adhesive 3 (Other); P-4 (Other); P-15 (Other); P-16 (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Coloplast A/S
- Primary completion
- Jun 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Peel Force |
5.2; 3; 2.1; 3.3; 3.7; 4.4 | — |
Summary
This study investigates the impact and adhesion of new adhesives to the skin.
Eligibility Criteria
Inclusion Criteria
- Have given written informed consent
- Be at least 18 years of age and have full legal capacity
- Have intact skin on the area used in the investigation
Exclusion Criteria
- Currently receiving or have within the past 2 months received radio- and/or chemotherapy
- Currently receiving or have within the past months received topical steroid treatment in the abdominal skin area or systemic steroid (tablet/injection) treatment.
- Are pregnant or breastfeeding
- Have dermatological problems in the abdominal area (assessed by investigator)
Data sourced from ClinicalTrials.gov (NCT03200444). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.