Multicenter and Open Pilot Clinical Study on the Safety of a New One-piece Convex Appliance in Patients With Enterostomy

B. Braun

Status: Completed

Conditions: Enterostomy

Treatments: Device: Flexima Active soft convexe

Study type: Interventional

Funder types: Industry

Identifiers

NCT02507726

OPM-G-H-1501

Details and patient eligibility

About

This study evaluates the performance of a new 1-piece ostomy convex appliance in patients with enterostomy.

Full description

Primary outcome Measure:

To describe Investigational Device performance in term of level of leakage under the skin protector

Secondary Outcome Measure:

• Assessment of the condition of peristomal skin
• Assessment of other performance criteria
• Assessment of AEs for each patient

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patient is at least 18 years old,
• patient having a colostomy or an ileostomy for at least 1 month,
• patient having a stoma's diameter inferior to 45 mm,
• patient having a flat or flushed or slightly retracted stoma,
• patient using currently a one-piece soft convex or standard ostomy appliance with closed or drainable bags,
• patient using a minimum of 1 product per day with closed pouches or minimum 1 product per two days with drainable pouches
• patient capable to apply and remove the pouch himself or with the help of a caregiver (except health care professional)
• patient having a mental capacity to participate to the study (i.e. to understand the study and to answer to the questions)
• patient agreeing to test investigational product during 14(±3) days.
• patient covered by social security

Exclusion criteria

• patient experiencing repeated leakages with his current appliance,
• patient receiving or having received, within the last month, chemotherapy or radiotherapy or corticotherapy,
• patient having a deeply retracted stoma,
• patient currently suffering from peristomal skin complications (bleeding or severe irritation or red and broken skin at the time of inclusion),
• patient already participating in another clinical study or who have previously participated in this investigation,
• pregnant or breast-feeding woman

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Flexima Active Soft convexe

Experimental group

Description:

Flexima Active soft convexe (1 to 3 appliances per day)

Treatment:

Device: Flexima Active soft convexe