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Study to Evaluate the Performance of a New 2-piece Ostomy Appliance vs. Flexima® 3S in Patients With Enterostomy

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ClinicalTrials.gov Identifier: NCT03572673
Recruitment Status : Unknown
Verified June 2018 by BBraun Medical SAS.
Recruitment status was:  Recruiting
First Posted : June 28, 2018
Last Update Posted : June 28, 2018
Sponsor:
Information provided by (Responsible Party):
BBraun Medical SAS

Study Description
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Brief Summary:
To compare the performance of the comparator Flexima 3S appliance to a new 2-piece appliance in patients with enterostomy.

Condition or disease Intervention/treatment Phase
Enterostomy Device: Flexima 3S Device: New 2-piece ostomy appliance Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Randomized Controlled Multicenter Study to Evaluate the Performance of a New 2-piece Ostomy Appliance vs. Flexima® 3S in Patients With Enterostomy
Actual Study Start Date : May 8, 2018
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ostomy

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Flexima 3S
Flexima 3S is a 2-piece ostomy appliance composed with an adhesive base plate and a drainable pouch for collecting stools (1 base plate for 5 days and 1 pouch for 5 days)
 Device: Flexima 3S
Flexima 3S (2-piece appliance) with drainable pouch
Other Name: Class 1 appliance for patients having an enterostoma
Experimental: New 2-piece ostomy appliance
New 2-piece appliance is a 2-piece ostomy appliance composed with an adhesive base plate and a drainable pouch for collecting stools (1 base plate for 5 days and 1 pouch for 5 days)
 Device: New 2-piece ostomy appliance
New 2-piece ostomy appliance with drainable pouch
Other Name: Class 1 appliance for patients having an enterostoma


Outcome Measures
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Primary Outcome Measures :
  1. Change from baseline in base plate wear time, on average every 5 days, up to 21 (±3) days, for each study period [ Time Frame: On average every 5 days, up to 21 (±3) days for each period ]
    For each base plate, the wear time will be evaluated during 21 (±3) days


Secondary Outcome Measures :
  1. Assessment of the condition of peristomal skin [ Time Frame: After base plate removal at protocol visit 1 (day 0) and visit 2 (at 21 (±3) days) ]
    Using a standardized measuring ostomy skin tool

  2. Assessment of the main reason of base plate removal [ Time Frame: From date of randomization, on average every 5 days, after each base plate removal, up to 21 (±3) days for each study period ]
    After each base plate removal, the patient will describe on a 7-point scale the main reason of base plate removal ("habit", "hygiene", "leakage under the base plate", "unsticking of the base plate periphery", "unsticking of the base plate, not only on the periphery", "ask for the study but the base plate could stay longer in place", "other, to specify". No value is considered as the better outcome, it's only descriptive value.

  3. Assessment of acceptability [ Time Frame: At the end of each study period (21 (±3) days), at visit 2 (21 (±3) days) and at visit 3 (42 (±6) days) ]
    At the end of each study period (21 (±3) days), the patient will assess on a 4-point scale each parameter of acceptability ("very good", "good", "bad", "very bad". The "very good" value is considered as the better outcome.

  4. Assessment of use of accessories [ Time Frame: From date of randomization, on average every 5 days, after each base plate removal, up to 21 (±3) days for each study period ]
    After each base plate removal, the patient will describe on a 8-point scale the use of accessories ("none", "protective spray", "powder", "paste", "ring", "adhesive remover", "belt", "other, to specify". No value is considered as the better outcome, it's only descriptive value.

  5. Preference between Flexima® 3S and the new 2-piece ostomy appliance [ Time Frame: At the end of the study, at 42 (±6) days ]
    At the end of the study, the patient will notify the preference between Flexima® 3S and the new 2-piece appliance

  6. Safety: Adverse(s) Event(s) [ Time Frame: From date of randomization until the date of first adverse event, assessed up to 42 (±6) days ]
    Description of all adverse event related or not to the devices studied


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patient having a colostomy or an ileostomy for at least 1 month
  • patient currently using a flat appliance
  • patient wearing his appliance, on average, at least 5 days
  • patient with a stoma's diameter less than 65 mm
  • patient who agrees to participate in the evaluation and who have signed the inform consent
  • patient having a mental capacity to participate to the study (i.e. to understand the study and to answer to the questions)

Exclusion Criteria:

  • Patient currently suffering from peristomal skin complications (bleeding or red and broken skin at the time of inclusion)
  • Patient receiving or having received, within the last month, chemotherapy or corticotherapy
  • Patient already participating in another clinical study or who have previously participated in this investigation
  • Pregnant or breast-feeding woman
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03572673


Contacts
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Contact: Aude Michaud +33632542788 aude.michaud@bbraun.com

Locations
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Malaysia
Hospital Selayang Recruiting
Batu Caves, Malaysia, 68100
Contact: Fitjerald Henry, Dr    +6012-3730057    geraldh260311@gmail.com   
Hospital Canselor Tuanku Muhriz Recruiting
Kuala Lumpur, Malaysia, 56000
Contact: Ismail Sagap, Pr    +6019-3211261    drisagap@yahoo.com   
Sponsors and Collaborators
BBraun Medical SAS
More Information
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Responsible Party: BBraun Medical SAS
ClinicalTrials.gov Identifier: NCT03572673    
Other Study ID Numbers: OPM-G-H-1705
First Posted: June 28, 2018    Key Record Dates
Last Update Posted: June 28, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No