Investigating the Safety and Performance of Two New 1-piece Ostomy Products Compared With SenSura 1-piece

Study Overview
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Brief Summary
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The aim of the current investigation is to investigate the performance of two new 1-piece ostomy products

Detailed Description
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The present investigation aims at testing the performance and safety of the two new 1-piece ostomy products

Official Title
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Investigating the Safety and Performance of Two New 1-piece Ostomy Products in 180 Subjects With Ileostomy

Conditions
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Ileostomy - Stoma

Intervention / Treatment
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* Device: Coloplast Test Product 1
* Device: Coloplast Test Product 2
* Device: Coloplast SenSura


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have given written informed consent and signed letter of authority (mandatory in DK) Be at least 18 years of age and have full legal capacity. Be able to handle the products themselves Have an ileostomy with a diameter between 10 and 40 mm. Have had their ostomy for at least three months. Have within the last month used a 1-piece flat product with open bag Currently using midi or maxi bags Willing to use minimum 1 product every second day, i.e. maximum 2 days wear time. Be suitable for participation in the investigation Must be able to use custom cut product Negative result of a pregnancy test for women of childbearing age (only DK) Exclusion Criteria: Currently receiving or have within the past 2 months received radio- and/or chemotherapy. Currently receiving or have within the past month received systemic steroid or local treatment in the peristomal area Are pregnant or breastfeeding Participating in other interventional clinical investigations or have previously participated in this investigation Has participated in the previous explorative Coloplast studies CP236 and CP237 Are currently or during the study using ostomy belt Has a stoma below skin surface Currently suffering from peristomal skin problems (i.e.bleeding and/or broken skin) Has known hypersensitivity towards any of the test products

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: Treatment sequence 1; First Coloplast Test product 1<br>The subjects are randomised 1:1:1 into six possible treatment groups to ensure random allocation of treatment to periods. Subjects are first allocated to test Coloplast Test product 1 and secondly test either: Coloplast Test product 1 and thereafter Coloplast SenSura Coloplast Sensura and thereafter Coloplast Test product 2 | Device: Coloplast Test Product 1<br>* Coloplast Test product 1 is a newly developed 1-piece ostomy appliance<br>Device: Coloplast Test Product 2<br>* Coloplast Test product 2 is a newly developed 1-piece ostomy appliance<br>Device: Coloplast SenSura<br>* SenSura 1-piece is the commercial available CE-marked SenSura 1-piece from Coloplast A/S.<br>* Other names: SenSura 1-piece;|
| Experimental: Treatment seqence 2; First Coloplast Test product 2.<br>The subjects are randomised 1:1:1 into six possible treatment groups to ensure random allocation of treatment to periods. Subjects are first allocated to test Coloplast Test product 2 and secondly test either: Coloplast Test product 1 and thereafter Coloplast SenSura Coloplast Sensura and thereafter Coloplast Test product 1 | Device: Coloplast Test Product 1<br>* Coloplast Test product 1 is a newly developed 1-piece ostomy appliance<br>Device: Coloplast Test Product 2<br>* Coloplast Test product 2 is a newly developed 1-piece ostomy appliance<br>Device: Coloplast SenSura<br>* SenSura 1-piece is the commercial available CE-marked SenSura 1-piece from Coloplast A/S.<br>* Other names: SenSura 1-piece;|
| Experimental: Treatment sequence 3, First Coloplast SenSura<br>The subjects are randomised 1:1:1 into six possible treatment groups to ensure random allocation of treatment to periods. Subjects are first allocated to test Coloplast SenSura and secondly test either: Coloplast Test product 2 and thereafter Coloplast Test product 1 Coloplast Test product 1 and thereafter Coloplast Test product 2 | Device: Coloplast Test Product 1<br>* Coloplast Test product 1 is a newly developed 1-piece ostomy appliance<br>Device: Coloplast Test Product 2<br>* Coloplast Test product 2 is a newly developed 1-piece ostomy appliance<br>Device: Coloplast SenSura<br>* SenSura 1-piece is the commercial available CE-marked SenSura 1-piece from Coloplast A/S.<br>* Other names: SenSura 1-piece;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Leakage | The fraction of baseplates with No leakage/seeping under the baseplate was measured. Leakage/seeping under the baseplate was assessed after each baseplate change. | 14 +- 1 days |