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.

Study Overview

• Status: Completed
• Conditions: Colostomy
• Intervention / Treatment: Device: Flexima Active; Device: Sensura

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Phase 4

Contacts and Locations

Study Locations

• France
  • Paris, France
    • Bichat Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Sensura; Ostomy pouch	Device: Flexima Active
Experimental: Flexima Active; Ostomy pouch	Device: Sensura

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Level of leakage under the skin protector of Flexima Active in comparison with level of leakage under the skin protector of Sensura.	The patient will evaluate the level of leakage under the skin protector after each removal of pouch. A 4 scale level will be used: "no leakage under the skin protector",; "leakage under the skin protector not soiling clothes",; "leakage under the skin protector soiling clothes",; "sudden and massive leakage under the skin protector".	Up to one day for closed pouches and up to two days for drainable pouches.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of the condition of peristomal skin		At V1 and V2 protocol visits (at day 0 and day 14)
Acceptability of each pouch	Acceptability is defined by those criteria: Wearing comfort, Flexibility, Conformability (skin protector adaptation to the skin relief), Ease of handling (pouch application and pouch removal), Tack (immediate adhesivity to the skin after application), Adhesivity (during wear time), Residues on the skin after pouch removal, Filter performance (odours neutralization, limitation of ballooning of the bag), Security feeling with skin protector, Overall security feeling, Overall satisfaction with skin protector, Overall satisfaction with the appliance	At each protocol visit (day 0, day 14 and day 28)
Preference between Flexima® Active and Sensura®		At each protocol visits (at day 0, day 14 and day 28)
Assessment of the quality of life with Stoma-QoL questionnaire		At each protocol visits (at day 0, day 14 and day 28)
Adverse(s) Event(s)		At each protocol visits (at day 0, day 14 and day 28)

Collaborators and Investigators

• Sponsor: BBraun Medical SAS

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): October 1, 2014

Study Registration Dates

• First Submitted: October 25, 2013
• First Submitted That Met QC Criteria: August 21, 2014
• First Posted (Estimate): August 22, 2014

Study Record Updates

• Last Update Posted (Estimate): July 31, 2015
• Last Update Submitted That Met QC Criteria: July 30, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: OPM-G-H-1301