A Clinical Investigation Evaluating Three New 1-piece Ostomy Products

Study Overview
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Brief Summary
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This investigation evaluates three new ostomy appliances and their impact on the peristomal skin.

Official Title
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A Clinical Investigation Evaluating Three New 1-piece Ostomy Products

Conditions
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Ileostomy - Stoma

Intervention / Treatment
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* Device: Ostomy device 1
* Device: Ostomy device 2
* Device: 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 Have an ileostomy with a diameter between 10 and 55 mm Be able to handle the Clinical App. and product themselves Must be able to use custom cut product Minimum change of product every second day If current product is SenSura Mio - Be willing to use Maxi bag during investigation Subject using Sensura or Sensura Mio flat 1 pc. open for at least two weeks before inclusion in the study. 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 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: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ostomy device 1<br>In this arm the subjects test a new ostomy device consisting of a known adhesive and a new top film | Device: Ostomy device 1<br>* This device consists of a known adhesive and a new top film<br>|
| Experimental: Ostomy device 2<br>In this arm the subjects test a new ostomy device consisting of a new adhesive and a known top film | Device: Ostomy device 2<br>* This device consists of a new adhesive and a known top film<br>|
| Experimental: Ostomy device 3<br>In this arm the subjects test a new ostomy device consisting of a known adhesive and a new top film | Device: Ostomy device 3<br>* This device consists of a known adhesive and a new top film<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 Tran epirdermal water loss is a maesure 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 of water increases leading to a higher trans epidermal water loss. Thus, trans epidermal water loss is used to assess the damage to the skin. | 7 days |