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

Enterostomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03572673
• Other study ID #: OPM-G-H-1705
• Status: Recruiting
• Phase: N/A
• Start date: May 8, 2018
• Est. completion date: April 2019

Study information

• Verified date: June 2018
• Source: BBraun Medical SAS
• Contact: Aude Michaud
• Phone: +33632542788
• Email: aude.michaud[@]bbraun.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 38
• Est. completion date: April 2019
• Est. primary completion date: April 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Enterostomy

Intervention

Device:
• Flexima 3S
Flexima 3S (2-piece appliance) with drainable pouch
• New 2-piece ostomy appliance
New 2-piece ostomy appliance with drainable pouch

Locations

Country	Name	City	State
Malaysia	Hospital Selayang	Batu Caves
Malaysia	Hospital Canselor Tuanku Muhriz	Kuala Lumpur

Sponsors (1)

Lead Sponsor	Collaborator
BBraun Medical SAS

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Assessment of the condition of peristomal skin	Using a standardized measuring ostomy skin tool	After base plate removal at protocol visit 1 (day 0) and visit 2 (at 21 (±3) days)
Secondary	Assessment of the main reason of base plate removal	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
Secondary	Assessment of acceptability	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)
Secondary	Assessment of use of accessories	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
Secondary	Preference between Flexima® 3S and the new 2-piece ostomy appliance	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
Secondary	Safety: Adverse(s) Event(s)	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