An Investigation Exploring Adhesive Materials and Their Ability to Handle Moisture

Study Overview
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Brief Summary
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The aim is to investigate the impact that water absorption properties in adhesives has on adhesion.

Official Title
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An Investigation Exploring Adhesive Materials and Their Ability to Handle Moisture

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Other: Strip A
* Other: Strip B
* Other: Strip C


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 month 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) Participate in other clinical investigations or have previously participated in this investigation

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
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Strip A (wet)<br>Six strips of Strip A are applied on skin wetted with two different buffers (3 strips each) | Other: Strip A<br>* Adhesive strip A<br>|
| Experimental: Strip A (dry)<br>Six strips of Strip A are applied on skin that is dry (3 strips) and wetted with buffer (3 strips) | Other: Strip A<br>* Adhesive strip A<br>|
| Experimental: Strip B (wet)<br>Six strips of Strip B are applied on skin wetted with two different buffers (3 strips each) | Other: Strip B<br>* Adhesive strip B<br>|
| Experimental: Strip B (dry)<br>Six strips of Strip B are applied on skin that is dry (3 strips) and wetted with buffer (3 strips) | Other: Strip B<br>* Adhesive strip B<br>|
| Experimental: Strip C (wet)<br>Six strips of Strip C are applied on skin wetted with two different buffers (3 strips each) | Other: Strip C<br>* Adhesive strip C<br>|
| Experimental: Strip C (dry)<br>Six strips of Strip C are applied on skin that is either dry (3 strips) or wetted with buffer (3 strips) | Other: Strip C<br>* Adhesive strip C<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peel force used to removed adhesive | The three strips applied to skin that has received the same treatment (either buffer 1, buffer 2 or dry) are removed at three different time points (max 60 min) and the peel force is measured. Peel force (90 degree angle from skin) The tensile tester was mounted on a tripod under which the subject was lying. In this way the tensile tester measures the force (Newton), which was needed to remove the adhesive from the skin with a constant speed and with a mean angel of 90° | 60 min |