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

June 19, 2018 updated by: BBraun Medical SAS

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

38

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Malaysia
      • Batu Caves, Malaysia, 68100
        • Recruiting
        • Hospital Selayang
        • Contact:
      • Kuala Lumpur, Malaysia, 56000
        • Recruiting
        • Hospital Canselor Tuanku Muhriz
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Class 1 appliance for patients having an enterostoma

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
On average every 5 days, up to 21 (±3) days for each period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
After base plate removal at protocol visit 1 (day 0) and visit 2 (at 21 (±3) days)
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.
From date of randomization, on average every 5 days, after each base plate removal, up to 21 (±3) days for each study period
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.
At the end of each study period (21 (±3) days), at visit 2 (21 (±3) days) and at visit 3 (42 (±6) days)
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.
From date of randomization, on average every 5 days, after each base plate removal, up to 21 (±3) days for each study period
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
At the end of the study, at 42 (±6) days
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
From date of randomization until the date of first adverse event, assessed up to 42 (±6) days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

BBraun Medical SAS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 8, 2018

Primary Completion (Anticipated)

April 1, 2019

Study Completion (Anticipated)

April 1, 2019

Study Registration Dates

First Submitted

April 23, 2018

First Submitted That Met QC Criteria

June 19, 2018

First Posted (Actual)

June 28, 2018

Study Record Updates

Last Update Posted (Actual)

June 28, 2018

Last Update Submitted That Met QC Criteria

June 19, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • OPM-G-H-1705

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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