Investigation of Two Newly Developed 2-piece Convex Baseplates in Subjects With Ileostomy

Study Overview
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Brief Summary
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The aim of the current investigation is to develop new soft and more flexible 2-piece convex ostomy appliances

Official Title
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Investigation of Two Newly Developed 2-piece Convex Baseplates in Subjects With Ileostomy

Conditions
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Stoma - Ileostomy

Intervention / Treatment
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* Device: Coloplast Test product Y
* Device: Coloplast Test product Z


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have given written informed consent and signed letter of authority. Are at least 18 years of age and have full legal capacity. Have had their ileostomy for at least 3 months. Have used a 2-piece convex ostomy product during the last month. Are willing and able to comply with investigation procedures. Have an ileostomy with a diameter of 30 mm or less. Have experienced leakage (seeping) under the baseplate at least 2 times during the last two weeks. Exclusion Criteria: Currently suffering from peristomal skin problems (i.e. bleeding or broken skin). Currently receiving or have within the past 2 month received radio- and/or chemotherapy. Currently receiving or have within the past month received local (peristomal area) or systemic steroid treatment. Are pregnant or breastfeeding. Have a loop ostomy (also called double-barrel or ostomy with two outlets). Known hypersensitivity toward any of the test products. Participating in other interventional clinical investigations or have previously participated in this 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: First Coloplast Test product Z; then Coloplast Test product Y<br>The subjects first test Coloplast Test product Z and after cross-over Coloplast Test product Y | Device: Coloplast Test product Y<br>* Coloplast Test product Y is a newly developed 2-piece convex ostomy appliance<br>* Other names: Coloplast 2-piece Convex appliance Test product Y;Device: Coloplast Test product Z<br>* Coloplast Test product Z is a newly developed 2-piece convex ostomy appliance<br>* Other names: Coloplast 2-piece convex appliance test product Z;|
| Experimental: First Coloplast Test product Y, Then Coloplast Test product Z<br>The subjects first test test product Y and after cross-over test product Z | Device: Coloplast Test product Y<br>* Coloplast Test product Y is a newly developed 2-piece convex ostomy appliance<br>* Other names: Coloplast 2-piece Convex appliance Test product Y;Device: Coloplast Test product Z<br>* Coloplast Test product Z is a newly developed 2-piece convex ostomy appliance<br>* Other names: Coloplast 2-piece convex appliance test product Z;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Degree of Leakage | The degree of leakage is measured using a 32-point scale developed by Coloplast A/S, where 0 represents No leakage (best possible outcome) and 32 points represents full-plate leakage (worst possible outcome). The degree of leakage was measured at each baseplate change. | 14 days |