Randomized Controlled Multicenter Study to Evaluate the Performance of Flexima® Active vs. Sensura® in Patients With Colostomy
NCT ID: NCT02223104
Last Updated: 2015-07-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
70 participants
INTERVENTIONAL
2013-10-31
2014-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Sensura
Ostomy pouch
Flexima Active
Flexima Active
Ostomy pouch
Sensura
Interventions
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Flexima Active
Sensura
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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BBraun Medical SAS
INDUSTRY
Responsible Party
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Locations
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Bichat Hospital
Paris, , France
Countries
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Other Identifiers
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OPM-G-H-1301
Identifier Type: -
Identifier Source: org_study_id