Multicenter Pilot Study to Describe the Performance of a New Device in Patients With Colostomy

Multicenter Pilot Study to Describe the Performance of a New Device in Patients With Colostomy

The study evaluates the efficacy of a new 2-piece appliance in patients with colostomy.

Inclusion Criteria:

• Patient is at least 18 years old
• Patient having a colostomy with a diameter less than 30 mm for users of Ø 55 mm pouches or having a colostomy with a diameter less than 40 mm for users of Ø 65 mm pouches
• Patient having a colostomy for at least 1 month
• Patient using currently the two-piece flat ostomy appliance Flexima®/Softima® 3S for at least 2 weeks and being satisfied
• Patient having a stoma protusion smaller than or equal to 1.5 cm
• Patient capable to apply and remove the appliance 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 the new appliance during the training phase (5±3 days) and during the study device usage phase (14±3 days)
• Patient covered by social security

Exclusion Criteria:

• Patient experiencing repeated leakages with the usual pouching system
• 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, radiotherapy or corticotherapy
• Patient already participating in another clinical study or who have previously participated in this investigation
• Pregnant or breast-feeding woman