Investigating the Adhesion of New Adhesive to the Skin

Study Overview
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Brief Summary
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The adhesion of the new adhesive strips is investigated on healthy volunteers

Detailed Description
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Inclusion visit: Introduction to the study Inclusion in study Baseline information is obtained Instruct subject to pre-strip of abdominal skin Test visits 1-25 (up to maximum 25 visits per subject. (1-3 days after pre-stripping the abdominal skin): Baseline measurements are conducted on both sides of the stomach (TEWL, hydration, erythema, pH - 3 repeated measurements under each adhesive strip area (upper, middle and bottom of adhesive strip) Potential wetting of skin - shower/bicycle exercise (max 60 minutes) and after-wetting baseline measurements are conducted (TEWL, hydration, erythema, pH - 3 times/strips (upper, middle and bottom of adhesive strip)) Adhesive strips are weighted and applied Potential shower/bicycle exercise (max 60 minutes) Adhesive strips are removed at pre-defined timeslots (peel force measured) Discomfort when strip was peeled of is evaluated by subject (VAS) Measurements are conducted (TEWL, hydration, erythema, pH - 3 times/strips (upper, middle and bottom of adhesive strip)) Acclimatization ½ Measurements are conducted (TEWL, hydration, erythema, pH - 3 times/strips (upper, middle and bottom of adhesive strip)) Adhesive strips are weighed Photo of adhesive strips The subjects can be asked to apply and change strips every 24 hours between two test visits but for a maximum of 10 days between two visits. The strips should be applied at the same place every time.

Official Title
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A Pilot Evaluation Exploring New Adhesive Materials and Their Ability to Handle Moisture From Abdominal and Peristomal Skin

Conditions
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Ileostomy - Stoma

Intervention / Treatment
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* Other: Standard adhesive 1
* Other: Standard adhesive 2
* Other: PL4
* Other: PL16-L


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test of new adhesive strips<br>The subjects will test adhesives strips made of 4 different adhesives: Standard adhesive 1 Standard adhesive 2 PL4 PL16-L | Other: Standard adhesive 1<br>* This strip contains a standard hydrocolloid adhesive found in ostomy devices<br>Other: Standard adhesive 2<br>* This strip contains a standard hydrocolloid adhesive found in ostomy devices<br>Other: PL4<br>* This strip contains a new adhesive<br>Other: PL16-L<br>* This strip contains a new adhesive<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Swelling of the adhesive | Swelling of adhesive strips measured by weight (difference between the weight of the strip before and after use) | 24 hours |