A Clinical Investigation Examining the Performance and Handling of New 2-piece Ostomy Products in 28 People With an Ileostomy.

Study Overview
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Brief Summary
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To assess the functionality and safety of the test products and also assess the products ability to collect stool without interfering with the stoma.

Conditions
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Ileostomy - Stoma

Intervention / Treatment
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* Device: Coloplast Test A
* Device: Coloplast Test B
* Device: Own product
* Device: Coloplast Test C
* Device: Coloplast Test D


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Had given written informed consent Was at least 18 years of age Was able to handle the appliances themselves or with help from a caregiver (e.g. spouse) Had an ileostomy with a diameter between 15-45 mm Have had an ileostomy for at least 3 months Currently used a 2-piece flat appliance Exclusion Criteria: Used irrigation during the investigation (flush stoma with water) Currently received or had within the past 2 months received radio- and/or chemotherapy. Currently received or had within the past month received local or systemic steroid treatment in the peristomal area. Was pregnant or breast feeding Participated in other interventional studies that could interfere with this one or had previously participated in this investigation. Had a baseplate wear time of more than three days Suffered from peristomal skin problems that precluded participation in the investigation (assessed by the investigation nurse)

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: Coloplast Test A, Coloplast Test B, Own product<br>The subjects first test Coloplast Test A and thereafter Coloplast Test B and finally their own product for 14 days | Device: Coloplast Test A<br>* Coloplast Test A is a new ostomy appliance developed by Coloplast A/S<br>Device: Coloplast Test B<br>* Coloplast Test B is a newly developed ostomy appliance developed by Coloplast A/S<br>Device: Own product<br>* Own product is tested to get baseline results. Own product can be any 2-piece product that is commercially available. The manufactures can be Coloplast, Hollister, Convatec, Dansac, B. Braun and others.<br>|
| Experimental: Coloplast Test C , Coloplast Test D, Own product<br>The subjects first test Coloplast Test C and thereafter Coloplast Test D and finally their own product for 14 days | Device: Own product<br>* Own product is tested to get baseline results. Own product can be any 2-piece product that is commercially available. The manufactures can be Coloplast, Hollister, Convatec, Dansac, B. Braun and others.<br>Device: Coloplast Test C<br>* Coloplast Test C is a new ostomy appliance developed by Coloplast A/S<br>Device: Coloplast Test D<br>* Coloplast Test D is a new ostomy appliance developed by Coloplast A/S<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Degree of Leakage | Degree of leakage is measured on a 24 point scale where 0 represents no leakage (best possible outcome) and 24 represents leakage on the whole plate (worst possible outcome). | 14 days |