A Clinical Investigation of New Ostomy Appliances

Study Overview
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Brief Summary
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This is an open-labelled randomized cross-over and controlled exploratory intervention that aims to include 20-30 patients with an ileostomy. Every patient is to test two new ostomy appliances each for two weeks. During the test a questionaire is to be filled out and interviews will take place. Primary parameter is leakage. A Study nurse will visit the participants in their homes every two week during the test.

Official Title
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An Open-labelled Randomized Cross-over and Controlled Exploratory Investigation Comparing Several Variants of a Newly Developed Ostomy Appliance With Regard to Performance in 20 Patients With Ileostomy

Conditions
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Leakage

Intervention / Treatment
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* Device: test product 1: new ostomy base plate with Coloplast as manufacturer
* Device: test product 2: new ostomy base plate with Coloplast as manufacturer


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 18 years. Have had an ileostomy for more than 3 months. Have used convex products for the last 1 month. Has given written Informed Consent. Have an ileostomy with a diameter between 15 and 33 mm. Have inward peristomal area Exclusion Criteria: Have loop ostomy Pregnant or breastfeeding. Known allergy towards any of the product components or ingredients. Currently receiving or have within the last 2 months received radio- and/or chemotherapy. Currently receiving or have within the past month received local or systemic steroid treatment in the peristomal area. Currently suffering from peristomal skin problems (i.e. bleeding or red and broken skin)

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: test product 1 first<br>own product (baseline) - test product 1 - test product 2 test product 1 = New ostomy base plate. Due to company confidentiality the product is just called test product 1 | Device: test product 1: new ostomy base plate with Coloplast as manufacturer<br>* test product 1 is tested first<br>|
| Experimental: test product 2 first<br>own product (baseline) - test product 2 - test product 1 test product 2 = New ostomy base plate. Due to company confidentiality the product is just called test product 2 | Device: test product 2: new ostomy base plate with Coloplast as manufacturer<br>* test product 2 is tested first<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Leakage Under the Base Plate Using a 24-point Scale | Leakage under the baseplate was measured with a 24 point scale where 0 points represents no leakage (best possible out come) and 24 points represents leakage on the whole plate (worst possible outcome) | Each product will be tested 2 weeks |