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

NCT03572673 | Unknown

• 1 other identifier: OPM-G-H-1705
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Enterostomy

Outcome Measures

Primary Outcomes (1)

• Change from baseline in base plate wear time, on average every 5 days, up to 21 (±3) days, for each study 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 Outcomes (6)

• Assessment of the condition of peristomal skin

  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

  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

  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

  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

  At the end of the study, at 42 (±6) days

Study Arms (2)

Flexima 3S

ACTIVE COMPARATOR

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

New 2-piece ostomy appliance

EXPERIMENTAL

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

Interventions

Flexima 3S DEVICE

Flexima 3S (2-piece appliance) with drainable pouch

Also known as: Class 1 appliance for patients having an enterostoma

Flexima 3S

New 2-piece ostomy appliance DEVICE

New 2-piece ostomy appliance with drainable pouch

Also known as: Class 1 appliance for patients having an enterostoma

New 2-piece ostomy appliance

Eligibility Criteria

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

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• BBraun Medical SAS: lead

Study Sites (2)

Hospital Selayang

Batu Caves, 68100, Malaysia

RECRUITING

Hospital Canselor Tuanku Muhriz

Kuala Lumpur, 56000, Malaysia

RECRUITING

Central Study Contacts

Aude Michaud

CONTACT

+33632542788; aude.michaud@bbraun.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2018
• First Posted: June 28, 2018
• Study Start: May 8, 2018
• Primary Completion: April 1, 2019
• Study Completion: April 1, 2019
• Last Updated: June 28, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

MY (2)