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

B. Braun

Status and phase

Completed

Phase 4

Conditions

Colostomy

Treatments

Device: Sensura

Device: Flexima Active

Study type

Interventional

Funder types

Industry

Identifiers

OPM-G-H-1301

Details and patient eligibility

About

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

Enrollment

70 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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