Multi-national, Safety and Performance Study of New Ostomy Product Compared to Standard Care

Study Overview
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Brief Summary
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The primary object of this study is to provide clinical documentation for the New base plate significantly 'reduces the degree of Leakage' under the base plate compared to Standard Care base plates. The secondary objectives are to provide clinical documentation on several performance and safety parameters on the New base plate compared to Standard Care base plates. The primary hypothesis is that the New base plate significantly reduces degree of leakage under the base plate compared to Standard Care base plates. Each test period will last for two weeks. In addition to this there will be one week run-in period on New base plate. The data will be collected by investigator in the Case Report Form at the inclusion visit, cross-over visit and termination visit. Data will also be collected by the subject in a questionnaire during the two test periods. The subjects will change their base plates on per need basis and continue with their normal changing pattern in the entire study period. 100 subjects with ileostomy will be included in the study. The subjects will be recruited from Europe including Denmark, Norway, Sweden, Iceland, Germany and France.

Official Title
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An Open-labelled, Randomised, Controlled, Comparative, Multi-national, Cross-over Study Investigating the Safety and Performance of a New 2-piece Ostomy Product Compared to 2-piece Standard Care Ostomy Products

Conditions
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Leakage, Skin Condition

Intervention / Treatment
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* Device: New ostomy base plate (SS)
* Device: Standard Care base plate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have given written Informed Consent Is at least 18 years old Has the mental capacity to understand the study guidelines and questionnaires Has had their ileostomy for at least 3 months Has an ileostomy with a diameter between 19-40 mm Is currently using a flat 2-piece product with with mechanical coupling Is able to change the base plate by themselves or with help from a caregiver (e.g. spouse) Has experienced leakage under the base plate at least once a week over the last 2 weeks Exclusion Criteria: Is pregnant or breast-feeding Currently receiving or has within the past 2 months received radio- and/or chemotherapy Currently using topical steroid product on peristomal skin (injections and oral treatment are accepted) Is currently using a convex base plate Participating in other clinical studies or has previously participated in this study

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard Care base plate<br>Standard care are the participants own product and can have several manufacture and brand names | Device: Standard Care base plate<br>* The base plate is applied to the skin around the stoma and an ostomy bag is clicked onto the base plate.<br>|
| Experimental: New ostomy base plate (SS)<br>SS = New ostomy base plate. Due to company confidentiality the product is called SS and this is not short for any name | Device: New ostomy base plate (SS)<br>* The base plate is applied to the skin around the stoma and an ostomy bag is clicked onto the base plate.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Degree of Output Under the Base Plate (Leakage). | Degree of output is measured by a 24-point leakage assessment scale (0 indicating no leakage and 24 indicating maximum leakage). | Each test product was assessed for 2 weeks. |