Randomized Controlled Multicenter Study to Evaluate the Performance of Flexima® Active vs. Sensura® in Patients With Colostomy

Study Overview
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Brief Summary
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The purpose of this study is to demonstrate that the performance of Flexima Active is non-inferior to the performance of Sensura.

Conditions
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Colostomy

Intervention / Treatment
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* Device: Flexima Active
* Device: Sensura


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patient is at least 18 years old patient having a colostomy with a diameter less than 50 mm for users of midi pouches or having a colostomy with a diameter less than 65 mm for users of maxi pouches patient having a colostomy for at least 1 month patient using currently a one-piece flat ostomy appliance with closed or drainable bags patient using minimum 1 product per day with closed pouches or minimum 1 product every two days with drainable pouches patient capable to apply and remove the pouch himself or with the help of a caregiver (except health care professional) patient having a mental capacity to participate to the study (i.e. to understand the study and to answer to the questions) patient agrees to test Flexima® Active (size midi or maxi, beige) during 14 days and Sensura® (size midi or maxi, beige) during 14 days patient covered by social security Exclusion Criteria: patient receiving or having received, within the last month, chemotherapy or radiotherapy patient currently suffering from peristomal skin complications (bleeding or red and broken skin at the time of inclusion) patient currently receiving or having received within the past three weeks systemic or local steroid medication in the peristomal skin 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: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Sensura<br>Ostomy pouch | Device: Flexima Active<br> <br> |
| Experimental: Flexima Active<br>Ostomy pouch | Device: Sensura<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of leakage under the skin protector of Flexima Active in comparison with level of leakage under the skin protector of Sensura. | The patient will evaluate the level of leakage under the skin protector after each removal of pouch. A 4 scale level will be used: no leakage under the skin protector, leakage under the skin protector not soiling clothes, leakage under the skin protector soiling clothes, sudden and massive leakage under the skin protector. | Up to one day for closed pouches and up to two days for drainable pouches. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of the condition of peristomal skin |  | At V1 and V2 protocol visits (at day 0 and day 14) | 
| Acceptability of each pouch | Acceptability is defined by those criteria: Wearing comfort, Flexibility, Conformability (skin protector adaptation to the skin relief), Ease of handling (pouch application and pouch removal), Tack (immediate adhesivity to the skin after application), Adhesivity (during wear time), Residues on the skin after pouch removal, Filter performance (odours neutralization, limitation of ballooning of the bag), Security feeling with skin protector, Overall security feeling, Overall satisfaction with skin protector, Overall satisfaction with the appliance | At each protocol visit (day 0, day 14 and day 28) | 
| Preference between Flexima® Active and Sensura® |  | At each protocol visits (at day 0, day 14 and day 28) | 
| Assessment of the quality of life with Stoma-QoL questionnaire |  | At each protocol visits (at day 0, day 14 and day 28) | 
| Adverse(s) Event(s) |  | At each protocol visits (at day 0, day 14 and day 28) |