An Explorative Randomized Controlled Investigation Evaluating Newly Developed Ostomy Products

Study Overview
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Brief Summary
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The primary objective of the investigation is to explore the acceptance of a newly developed adhesive.

Conditions
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Ileostomy

Intervention / Treatment
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* Device: Test A
* Device: Test B
* Device: Baseline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have given written informed consent and letter of authority Be at least 18 years of age and have full legal capacity Be able to handle the products her/himself Have an ileostomy with a diameter between 10 and 30 mm Willing to follow the product change schedule (one change per day) Have had their ostomy for at least three months Willing to use 1 piece open ostomy products during the test period Must be able to use a custom cut product Have intact skin Negative result of a pregnancy test for women of childbearing age Exclusion Criteria: Currently receiving or have within the past 2 months 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 Is pregnant or breastfeeding. Is participating in other interventional clinical investigations or have previously participated in this investigation Have a loop ileostomy Known hypersensitivity towards any of the test products

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Baseline - Test A - Test B<br>Three period investigation. First each subject tests baseline product, then Test A and finally Test B. Baseline product: the subject's usual product Test A: A newly developed 1-piece, open ostomy appliance for collecting feces Test B: A newly developed 1-piece, open ostomy appliance for collecting feces | Device: Test A<br>* Ostomy appliance<br>Device: Test B<br>* Ostomy appliance<br>Device: Baseline<br>* Ostomy appliance<br>|
| Experimental: Baseline - Test B - Test A<br>First each subject tests baseline product, then Test B and finally Test A. Baseline product: the subject's usual product Test A: A newly developed 1-piece, open ostomy appliance for collecting feces Test B: A newly developed 1-piece, open ostomy appliance for collecting feces | Device: Test A<br>* Ostomy appliance<br>Device: Test B<br>* Ostomy appliance<br>Device: Baseline<br>* Ostomy appliance<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Product Acceptance | Product acceptance was measurement qualitatively by interviews exploring the factors and mechanisms affecting the acceptance. The interview questions were formulated in such a way that was not possible to quantify the number of subjects accepting the test products. There were problems with test product performance and handling and therefore the acceptance of the products was not high. Product preference was secondary endpoint, where the subjects were asked whether they preffered their own product over the test products. This endpoint is the best measure we have for mimiking product acceptance. However, we are aware subjects could accept a product without preferring it over own product and the preferrence result might therefore not be accurate. The result presented below shows how many subjects preferred Test A/Test B over own product | 7 days per test period |