Evaluation of the Effect of Output on Newly Developed Adhesives

Study Overview
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Brief Summary
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The study investigates the impact real output has on the adhesion of the adhesives.

Official Title
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Evaluation of the Effect of Output on Newly Developed Adhesives

Conditions
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Ileostomy - Stoma

Intervention / Treatment
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* Other: Standard hydrocolloid adhesive
* Other: P-4
* Other: P-15
* Other: P-16


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 had a stoma for more than one year Have intact skin on the area used in the evaluation Has a stoma with a diameter up to (≤) 35 mm Have a peristomal area accessible for application of patches/adhesive strips (assessed by investigating scientist) 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 peristomal skin area or systemic steroid (tab-let/injection) treatment. Are pregnant or breastfeeding Having dermatological problems in the peristomal- or abdominal area (assessed by investigating scientist) Actively participating in other interventional 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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No

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 adhesives<br>On the peristomal area four different patches are applied to the skin. There is a bag welded on each patch. The bag contains real output. The difference between the four patches is that they consist of different adhesives. One patch is made of a standard hydrocolloid adhesive The primary endpoint is maesured after 8 hours and 24 hours And the three other patches consist of the newly developed adhesives. P-4 P-15 P-16 | Other: Standard hydrocolloid adhesive<br>* This patch is made of standard hydrocolloid adhesive<br>Other: P-4<br>* This patch is made of new adhesive<br>Other: P-15<br>* This patch is made of new adhesive<br>Other: P-16<br>* This patch is made of new adhesive<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Trans epidermal water loss | The trans epidermal water loss is measured on the peristomal skin using a probe. The trans epidermal water loss is a measure for the skins barrier function. There is always a loss of water from the skin due to natural evaporation. However, when the skin barrier is damaged the evaporation of water increases leading to a higher trans epidermal water loss. Thus, trans epidermal water loss is used to assess the damage to the skin. | 8 hours |