Status:
COMPLETED
Randomized Controlled Multicenter Study to Evaluate the Performance of Flexima® Active vs. Sensura® in Patients With Colostomy
Lead Sponsor:
BBraun Medical SAS
Conditions:
Colostomy
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to demonstrate that the performance of Flexima Active is non-inferior to the performance of Sensura.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2014
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT02223104
Start Date
October 1 2013
End Date
October 1 2014
Last Update
July 31 2015
Active Locations (1)
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1
Bichat Hospital
Paris, France