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

Not Applicable

• Conditions: Enterostomy
• Interventions: Device: Flexima 3S; Device: New 2-piece ostomy appliance

• Registration Number: NCT03572673
• Lead Sponsor: BBraun Medical SAS

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-04-23
• Study Start: 2018-05-08
• Status Verified: 2018-06
• Study First Submitted QC: 2018-06-19
• Last Update Submitted: 2018-06-19
• Study First Posted: 2018-06-28
• Last Update Posted: 2018-06-28
• Primary Completion: 2019-04
• Study Completion: 2019-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 38

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Flexima 3S	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)
New 2-piece ostomy appliance	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)

Primary Outcome Measures

Name	Time	Method
Change from baseline in base plate wear time, on average every 5 days, up to 21 (±3) days, for each study period	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

Name	Time	Method
Assessment of the condition of peristomal skin	After base plate removal at protocol visit 1 (day 0) and visit 2 (at 21 (±3) days)	Using a standardized measuring ostomy skin tool
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	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.
Preference between Flexima® 3S and the new 2-piece ostomy appliance	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
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	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.
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)	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.
Safety: Adverse(s) Event(s)	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

Trial Locations

Locations (2)

Hospital Selayang; 🇲🇾 Batu Caves, Malaysia

Hospital Canselor Tuanku Muhriz; 🇲🇾 Kuala Lumpur, Malaysia