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

B. Braun

Status: Unknown

Conditions: Enterostomy

Treatments: Device: Flexima 3S; Device: New 2-piece ostomy appliance

Study type: Interventional

Funder types: Industry

Identifiers

NCT03572673

OPM-G-H-1705

Details and patient eligibility

About

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

Enrollment: 38 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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38 participants in 2 patient groups

Flexima 3S

Active Comparator group

Description:

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)

Treatment:

Device: Flexima 3S

New 2-piece ostomy appliance

Experimental group

Description:

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)

Treatment:

Device: New 2-piece ostomy appliance