Study to Evaluate the Performance of a New 2-piece Ostomy Appliance vs. Flexima® 3S in Patients With Enterostomy

Study Overview
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Brief Summary
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To compare the performance of the comparator Flexima 3S appliance to a new 2-piece appliance in patients with enterostomy.

Official Title
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Randomized Controlled Multicenter Study to Evaluate the Performance of a New 2-piece Ostomy Appliance vs. Flexima® 3S in Patients With Enterostomy

Conditions
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Enterostomy

Intervention / Treatment
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* Device: Flexima 3S
* Device: New 2-piece ostomy appliance


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patient having a colostomy or an ileostomy for at least 1 month patient currently using a flat appliance patient wearing his appliance, on average, at least 5 days patient with a stoma's diameter less than 65 mm patient who agrees to participate in the evaluation and who have signed the inform consent patient having a mental capacity to participate to the study (i.e. to understand the study and to answer to the questions) Exclusion Criteria: Patient currently suffering from peristomal skin complications (bleeding or red and broken skin at the time of inclusion) Patient receiving or having received, within the last month, chemotherapy or corticotherapy Patient already participating in another clinical study or who have previously participated in this investigation Pregnant or breast-feeding woman

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 |
| --- | --- |
| Active Comparator: Flexima 3S<br>Flexima 3S is a 2-piece ostomy appliance composed with an adhesive base plate and a drainable pouch for collecting stools (1 base plate for 5 days and 1 pouch for 5 days) | Device: Flexima 3S<br>* Flexima 3S (2-piece appliance) with drainable pouch<br>* Other names: Class 1 appliance for patients having an enterostoma;|
| Experimental: New 2-piece ostomy appliance<br>New 2-piece appliance is a 2-piece ostomy appliance composed with an adhesive base plate and a drainable pouch for collecting stools (1 base plate for 5 days and 1 pouch for 5 days) | Device: New 2-piece ostomy appliance<br>* New 2-piece ostomy appliance with drainable pouch<br>* Other names: Class 1 appliance for patients having an enterostoma;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in base plate wear time, on average every 5 days, up to 21 (±3) days, for each study period | For each base plate, the wear time will be evaluated during 21 (±3) days | On average every 5 days, up to 21 (±3) days for each period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of the condition of peristomal skin | Using a standardized measuring ostomy skin tool | After base plate removal at protocol visit 1 (day 0) and visit 2 (at 21 (±3) days) | 
| Assessment of the main reason of base plate removal | After each base plate removal, the patient will describe on a 7-point scale the main reason of base plate removal (habit, hygiene, leakage under the base plate, unsticking of the base plate periphery, unsticking of the base plate, not only on the periphery, ask for the study but the base plate could stay longer in place, other, to specify. No value is considered as the better outcome, it's only descriptive value. | From date of randomization, on average every 5 days, after each base plate removal, up to 21 (±3) days for each study period | 
| Assessment of acceptability | At the end of each study period (21 (±3) days), the patient will assess on a 4-point scale each parameter of acceptability (very good, good, bad, very bad. The very good value is considered as the better outcome. | At the end of each study period (21 (±3) days), at visit 2 (21 (±3) days) and at visit 3 (42 (±6) days) | 
| Assessment of use of accessories | After each base plate removal, the patient will describe on a 8-point scale the use of accessories (none, protective spray, powder, paste, ring, adhesive remover, belt, other, to specify. No value is considered as the better outcome, it's only descriptive value. | From date of randomization, on average every 5 days, after each base plate removal, up to 21 (±3) days for each study period | 
| Preference between Flexima® 3S and the new 2-piece ostomy appliance | At the end of the study, the patient will notify the preference between Flexima® 3S and the new 2-piece appliance | At the end of the study, at 42 (±6) days | 
| Safety: Adverse(s) Event(s) | Description of all adverse event related or not to the devices studied | From date of randomization until the date of first adverse event, assessed up to 42 (±6) days |