Assessment of the Effect of Output on New Adhesives

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

Official Title
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The 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 patch
* Other: LT-2
* Other: LT-21
* Other: 33-20


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 (tablet/injection) treatment. Are pregnant or breastfeeding Having dermatological problems in the peri-stomal- 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 adhesive strips<br>On the peristomal skin 4 different patches are applied to the skin (Standard hydrocolloid adhesive patch; LT-2, LT21 and 33-20. There is a bag welded to each patch. Tthe bag contains real output. The difference between the four patches is that they are made of four different adhesives. The primary endpoint is measured after 8 hours and 24 hours. | Other: Standard hydrocolloid adhesive patch<br>* This patch is made of a standard hydrocolloid adhesive<br>Other: LT-2<br>* This patch is made of a new adhesive<br>Other: LT-21<br>* This patch is made of a new adhesive<br>Other: 33-20<br>* This patch is made of a 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 will increase leading to an increase in the trans epidermal water loss.Thus, trans epidermal water loss is used to assess the damage to the skin. Maesurents are taken at time 0 and after 8 hours of output exposure to the skin. | 8 hours |