Enterostomy
Conditions
Brief summary
This study evaluates the performance of a new 1-piece ostomy convex appliance in patients with enterostomy.
Detailed description
Primary outcome Measure: To describe Investigational Device performance in term of level of leakage under the skin protector Secondary Outcome Measure: * Assessment of the condition of peristomal skin * Assessment of other performance criteria * Assessment of AEs for each patient
Interventions
DEVICEFlexima Active soft convexe
The Investigational Device will be used during 14 +- 3 days.
Sponsors
BBraun Medical SAS
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* patient is at least 18 years old, * patient having a colostomy or an ileostomy for at least 1 month, * patient having a stoma's diameter inferior to 45 mm, * patient having a flat or flushed or slightly retracted stoma, * patient using currently a one-piece soft convex or standard ostomy appliance with closed or drainable bags, * patient using a minimum of 1 product per day with closed pouches or minimum 1 product per 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 agreeing to test investigational product during 14(±3) days. * patient covered by social security
Exclusion criteria
* patient experiencing repeated leakages with his current appliance, * patient receiving or having received, within the last month, chemotherapy or radiotherapy or corticotherapy, * patient having a deeply retracted stoma, * patient currently suffering from peristomal skin complications (bleeding or severe irritation or red and broken skin at the time of inclusion), * 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 |
|---|---|
| Flexima® Active Soft Convex ostomy appliance performance description in term of level of leakage under the skin protector | 14 +- 3 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability | baseline and 14 +- 3 days | — |
| Investigational product wear time | 14 +- 3 days | The patient will complete his patient diary after each Investigational Product removal |
| Investigational product adhesivity as measured by a Likert scale score (1-4) | 14 +- 3 days | — |
| Investigational product flexibility as measured by a Likert scale score (1-4) | 14 +- 3 days | — |
| Investigational product conformability as measured by a Likert scale score (1-4) | 14 +- 3 days | — |
| Convex ring suppleness of the Investigational product as measured by a Likert scale score (1-4) | 14 +- 3 days | — |
| Connection of the Investigational Product belt to the belt hear as measured by a Likert scale score (1-4) | 14 +- 3 days | — |
| Peristomal skin evaluation with DET score scale | baseline and 14 +- 3 days | — |
| Ease of Investigational Product handling as measured by a Likert scale score (1-4) | 14 +- 3 days | — |
| Investigational Product wearing comfort as measured by a Likert scale score (1-4) | 14 +- 3 days | — |
| Investigational Product leakage prevention as measured by a Likert scale score (1-4) | 14 +- 3 days | — |
| Feeling of Investigational Product security as measured by a Likert scale score (1-4) | 14 +- 3 days | — |
| Investigational Product overall satisfaction as measured by a Likert scale score (1-4) | 14 +- 3 days | — |
| Use of Investigational Product in the future as measured by a Likert scale score (1-2) | 14 +- 3 days | — |
| Residues on the skin after each Investigational Product removal as measured by a Likert scale score (1-4) | 14 +- 3 days | — |
Countries
France
Outcome results
None listed