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

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

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