Investigation of Two Newly Developed 1-piece Convex Baseplates in Subjects With Ileostomy and Colostomy

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 1-piece convex ostomy products.

Official Title
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Investigation of Two Newly Developed 1-piece Convex Baseplates in Subjects With Ileostomy and Colostomy

Conditions
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Ileostomy - Stoma, Colostomy - Stoma

Intervention / Treatment
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* Device: Coloplast Test V
* Device: Coloplast Test X


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 ostomy (ileo- or colostomy) for at least 3 months. Have used a 1-piece convex ostomy product during the last month. Are willing and able to comply with investigation procedures. Have a ostomy with a diameter of 33 mm or less. 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. Use irrigation during the investigation (flush the stoma with water). 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: FirstColplast Test V, Then Coloplast Test X<br>The subject tests two experimental coloplast products in a randomised order. Coloplast Test product V and after cross over ColoplastTest product X | Device: Coloplast Test V<br>* Coloplast Test product V is a newly developed 1-piece ostomy appliance<br>* Other names: Coloplast 1-piece convex Test product V;Device: Coloplast Test X<br>* Coloplast Test X is a newly developed 1-piece ostomy appliance<br>* Other names: Coloplast 1-piece convex Test product X;|
| Experimental: First Coloplast Test X, Then Coloplast Test V<br>The subjects test the two experimental Coloplast products in a randomised order: Coloplast Test product X and after cross over Coloplast Test product V | Device: Coloplast Test V<br>* Coloplast Test product V is a newly developed 1-piece ostomy appliance<br>* Other names: Coloplast 1-piece convex Test product V;Device: Coloplast Test X<br>* Coloplast Test X is a newly developed 1-piece ostomy appliance<br>* Other names: Coloplast 1-piece convex Test product X;|

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 (the best possible outcome) and 32 points represents full plate leakage (worst possible outcome). The degree of leakage is measured at each baseplate change | 14 days |