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

NCT02223104 | Completed Phase 4

• 1 other identifier: OPM-G-H-1301
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Colostomy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Assessment of the condition of peristomal skin

  At V1 and V2 protocol visits (at day 0 and day 14)

• Acceptability of each pouch

  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)

Study Arms (2)

Sensura

ACTIVE COMPARATOR

Ostomy pouch

Device: Flexima Active

Flexima Active

EXPERIMENTAL

Ostomy pouch

Device: Sensura

Interventions

Flexima Active DEVICE

Sensura

Sensura DEVICE

Flexima Active

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• patient receiving or having received, within the last month, chemotherapy or radiotherapy
• 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

Sponsors & Collaborators

• BBraun Medical SAS: lead

Study Sites (1)

Bichat Hospital

Paris, France

Location

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2013
• First Posted: August 22, 2014
• Study Start: October 1, 2013
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: July 31, 2015

Record last verified: 2015-07

Locations

FR (1)