NCT03289013
Completed
Not Applicable
A Pilot Evaluation Exploring New Adhesive Materials and Their Ability to Handle Moisture From Abdominal and Peristomal Skin
ConditionsIleostomy - Stoma
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Ileostomy - Stoma
- Sponsor
- Coloplast A/S
- Enrollment
- 5
- Locations
- 1
- Primary Endpoint
- Swelling of the adhesive
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
This study investigates the adhesion of new adhesives to the skin.
Investigators
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)
Outcomes
Primary Outcomes
Swelling of the adhesive
Time Frame: 21 days
1. Swelling of adhesive strips measured by weight (Difference between weight of strip before and after test)
Study Sites (1)
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