Ostomy
Conditions
Brief summary
To evaluate the satisfaction of patients of the Flexima®/Softima® 3S with 6 months follow-up. The primary variable is to evaluate the degree of satisfaction of patients in terms of leakage prevention, comfort and patient's feeling of security to the Flexima®/Softima® 3S.
Detailed description
The primary variable is to evaluate the degree of satisfaction of patients in terms of leakage prevention, comfort and patient's feeling of security to the Flexima®/Softima® 3S.
Interventions
DEVICE2 piece appliance for stomy
Use of the Flexima®/Softima® 3S during 6 months following the patient's usually frequency of appliance change
Sponsors
VERTICAL
EVAMED
BBraun Medical SAS
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient is at least 18 years old * Patient who has had a colostomy or an ileostomy or a jejunostomy or an urostomy for at least 1 month * Patient agreeing to participate to the study and having signed the informed consent form/information letter in accordance with local requirements * Patient for whom the use of Flexima®/Softima® 3S has already been decided within the regular planning of his treatment
Exclusion criteria
* Patient with cognitive problems, according to the investigator, preventing him from answering a questionnaire or for whom the evaluation could be a problem * Patient taking part in another clinical evaluation * Patient having more than one stomy * Patient vulnerable and under legal protection * Patient having had an known allergy to one of the components of the appliance * Patient previously using Flexima®/Softima® 3S
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| evaluation of the satisfaction of patients of the Flexima®/Softima® 3S with 6 months follow-up | the questions will be asked to the patient at each follow up visits (= at 1 month, 3 months and 6 months).Total Score will range from 3 to 12. A total score of 9 or more will define appropriate overall satisfaction. | The primary variable is to evaluate the degree of satisfaction of patients in terms of leakage prevention, comfort and patient's feeling of security to the Flexima®/Softima® 3S. For each item, the patient will evaluated the product thanks to a 4 points scale question (very good (4)/good(3)/ poor(2)/ very poor(1)) |
Countries
France
Contacts
Primary ContactGhislaine Martin
Backup ContactBénédicte Colomb
Outcome results
None listed