Enterostomy
Conditions
Brief summary
To compare the performance of the comparator Flexima 3S appliance to a new 2-piece appliance in patients with enterostomy.
Interventions
DEVICEFlexima 3S
Flexima 3S (2-piece appliance) with drainable pouch
DEVICENew 2-piece ostomy appliance
New 2-piece ostomy appliance with drainable pouch
Sponsors
BBraun Medical SAS
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in base plate wear time, on average every 5 days, up to 21 (±3) days, for each study period | On average every 5 days, up to 21 (±3) days for each period | For each base plate, the wear time will be evaluated during 21 (±3) days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of the main reason of base plate removal | From date of randomization, on average every 5 days, after each base plate removal, up to 21 (±3) days for each study period | 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. |
| Assessment of acceptability | At the end of each study period (21 (±3) days), at visit 2 (21 (±3) days) and at visit 3 (42 (±6) days) | 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. |
| Assessment of the condition of peristomal skin | After base plate removal at protocol visit 1 (day 0) and visit 2 (at 21 (±3) days) | Using a standardized measuring ostomy skin tool |
| Preference between Flexima® 3S and the new 2-piece ostomy appliance | At the end of the study, at 42 (±6) days | At the end of the study, the patient will notify the preference between Flexima® 3S and the new 2-piece appliance |
| Safety: Adverse(s) Event(s) | From date of randomization until the date of first adverse event, assessed up to 42 (±6) days | Description of all adverse event related or not to the devices studied |
| Assessment of use of accessories | From date of randomization, on average every 5 days, after each base plate removal, up to 21 (±3) days for each study period | 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. |
Countries
Malaysia
Contacts
Primary ContactAude Michaud
Outcome results
None listed