Assessment of New Ostomy Devices in Subjects Having an Ileostomy

Study Overview
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Brief Summary
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The study investigates the performance of three new adhesives with regard to leakage and the skin condition.

Official Title
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Assessment of New Enhanced Ostomy Devices in Real-life Set-tings in Subjects Having an Ileostomy

Conditions
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Ileostomy - Stoma

Intervention / Treatment
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* Device: SenSura Mio
* Device: Coloplast Ostomy device 1
* Device: Coloplast Ostomy device
* Device: Coloplast Ostomy device 3


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have given written informed consent and in DK: signed a letter of authority Be at least 18 years of age and have full legal capacity Have had their ileostomy for at least 3 months Must be able to use custom cut product Can use a product with max cut size 45 mm Self-reported problems with leakage (3 x within 14 days) Get a negative result of a pregnancy test for women of childbearing age (only DK) Exclusion Criteria: Are currently receiving or have within the past 2 months received radio-and/or chemotherapy (low doses chemotherapy are allowed for other indications than cancer, e.g. below 15 mg methotrexate for rheumatoid arthritis) Are currently receiving or have within the past month received topical steroid treatment in the peristomal skin area, e.g. lotion or spray. Systemic steroid treatment (e.g. injection, or tablet) are allowed. Are pregnant or breastfeeding Are participating in other interventional clinical investigations or have previously participated in this investigation 4.1. Exception: Participation in other Coloplast in-house clinical investigations are accepted under the circumstances that the subject has paused the activities in the investigation and are otherwise complying with the inclusion and exclusion criteria of this (CP264) protocol. Are currently suffering from peristomal skin problems i.e. bleeding and/or broken skin (assessed by the investigator) Have known hypersensitivity towards any of the products used in the 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: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br>The subjects test the products in the following order SenSura Mio (comparator) Coloplast Ostomy device 1 Coloplast Ostomy device 2 Coloplast Ostomy device 3 | Device: SenSura Mio<br>* SenSura Mio is a marked ostomy device which is used as the comparator in this study<br>Device: Coloplast Ostomy device 1<br>* Coloplast Ostomy device 1 a newly developed ostomy device<br>Device: Coloplast Ostomy device<br>* Coloplast Ostomy device 2 a newly developed ostomy device<br>Device: Coloplast Ostomy device 3<br>* Coloplast Ostomy device 3 a newly developed ostomy device<br>|
| Experimental: Arm 2<br>The subjects test the products in the following order SenSura Mio (comparator) Coloplast Ostomy device 1 Coloplast Ostomy device 3 Coloplast Ostomy device2 | Device: SenSura Mio<br>* SenSura Mio is a marked ostomy device which is used as the comparator in this study<br>Device: Coloplast Ostomy device 1<br>* Coloplast Ostomy device 1 a newly developed ostomy device<br>Device: Coloplast Ostomy device<br>* Coloplast Ostomy device 2 a newly developed ostomy device<br>Device: Coloplast Ostomy device 3<br>* Coloplast Ostomy device 3 a newly developed ostomy device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Trans epidermal water loss | Trans epidermal water loss is an objective skin measurement that is measures the evaporation of water on the skin surface using a probe (DermaLab).The trans epidermal water loss is a measure for the skins barrier function. There is always aloss of water from the skin due to evaporation. When the skin barrier is damaged this evaporation of water increases. Thus, transepidermal water loss can be used to assess skin damage | 14 days |