A Pilot Evaluation Exploring New Adhesive Materials and Their Ability to Handle Moisture From Abdominal and Peristomal Skin
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Coloplast A/S
- Enrollment
- 5
- Locations
- 1
- Primary Endpoint
- Swelling of the adhesive
Study Overview
Brief Summary
This study investigates the adhesion of new adhesives to the skin.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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)
Arms & Interventions
Testing of new adhesive strips
Each subject will test six adhesive strips on pre-stripped skin.
- Standard adhesive 1
- Standard adhesive 2
- LT-2
- LT-21
- LT-25
- 33-20
The six strips are applied on the abdominal skin. The order of the adhesive strips on the skin is randomized. The subjects will change the adhesive strips at home and the adhesion of adhesive strips will be measured at 5 visits.
Intervention: Standard adhesive 1 (Other)
Testing of new adhesive strips
Each subject will test six adhesive strips on pre-stripped skin.
- Standard adhesive 1
- Standard adhesive 2
- LT-2
- LT-21
- LT-25
- 33-20
The six strips are applied on the abdominal skin. The order of the adhesive strips on the skin is randomized. The subjects will change the adhesive strips at home and the adhesion of adhesive strips will be measured at 5 visits.
Intervention: Standard adhesive 2 (Other)
Testing of new adhesive strips
Each subject will test six adhesive strips on pre-stripped skin.
- Standard adhesive 1
- Standard adhesive 2
- LT-2
- LT-21
- LT-25
- 33-20
The six strips are applied on the abdominal skin. The order of the adhesive strips on the skin is randomized. The subjects will change the adhesive strips at home and the adhesion of adhesive strips will be measured at 5 visits.
Intervention: LT-2 (Other)
Testing of new adhesive strips
Each subject will test six adhesive strips on pre-stripped skin.
- Standard adhesive 1
- Standard adhesive 2
- LT-2
- LT-21
- LT-25
- 33-20
The six strips are applied on the abdominal skin. The order of the adhesive strips on the skin is randomized. The subjects will change the adhesive strips at home and the adhesion of adhesive strips will be measured at 5 visits.
Intervention: LT-21 (Other)
Testing of new adhesive strips
Each subject will test six adhesive strips on pre-stripped skin.
- Standard adhesive 1
- Standard adhesive 2
- LT-2
- LT-21
- LT-25
- 33-20
The six strips are applied on the abdominal skin. The order of the adhesive strips on the skin is randomized. The subjects will change the adhesive strips at home and the adhesion of adhesive strips will be measured at 5 visits.
Intervention: LT-25 (Other)
Testing of new adhesive strips
Each subject will test six adhesive strips on pre-stripped skin.
- Standard adhesive 1
- Standard adhesive 2
- LT-2
- LT-21
- LT-25
- 33-20
The six strips are applied on the abdominal skin. The order of the adhesive strips on the skin is randomized. The subjects will change the adhesive strips at home and the adhesion of adhesive strips will be measured at 5 visits.
Intervention: 33-20 (Other)
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)
Secondary Outcomes
No secondary outcomes reported