CompletedNCT02223104Updated Jul 31, 2015

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

A Phase 4 interventional study of Flexima Active and Sensura in Colostomy, sponsored by BBraun Medical SAS. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-07-31.

Sponsored by BBraun Medical SAS · Phase 4, Interventional, and Treatment

Phase: Phase 4
Study type: Interventional
Enrollment: 70
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study summary

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

Conditions studied

Colostomy

In context

Lead sponsor

BBraun Medical SAS is the lead sponsor of 13 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

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

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 design

Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover assignment
Masking: None (open label)
Enrollment: 70 participants (actual)

Study arms

Active comparator
Sensura
Ostomy pouch
Device: Flexima Active
Experimental
Flexima Active
Ostomy pouch
Device: Sensura

Interventions

DeviceFlexima Active
DeviceSensura

What researchers measure

Primary outcomes

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".
Time frame: Up to one day for closed pouches and up to two days for drainable pouches.

Secondary outcomes

Assessment of the condition of peristomal skin
Time frame: 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
Time frame: At each protocol visit (day 0, day 14 and day 28)
Preference between Flexima® Active and Sensura®
Time frame: At each protocol visits (at day 0, day 14 and day 28)
Assessment of the quality of life with Stoma-QoL questionnaire
Time frame: At each protocol visits (at day 0, day 14 and day 28)
Adverse(s) Event(s)
Time frame: At each protocol visits (at day 0, day 14 and day 28)

Study locations

1 site

Bichat Hospital
Paris, France

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jul 31, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02223104
Lead sponsor: BBraun Medical SAS
Responsible party: Sponsor
First posted: Aug 22, 2014
Start date: Oct 2013
Primary completion: Oct 2014
Completion: Oct 2014
Last update: Jul 31, 2015

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2015. You cannot join it, but the record below documents what was studied.

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