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

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

Study Overview

• Status: Completed
• Conditions: Enterostomy
• Intervention / Treatment: Device: Flexima Active soft convexe

Detailed 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

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Dijon, France, 21000
    • Patrick RAT

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Flexima Active Soft convexe; Flexima Active soft convexe (1 to 3 appliances per day)	Device: Flexima Active soft convexe; The Investigational Device will be used during 14 +- 3 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Flexima® Active Soft Convex ostomy appliance performance description in term of level of leakage under the skin protector	14 +- 3 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peristomal skin evaluation with DET score scale		baseline and 14 +- 3 days
Number of Participants with Adverse Events as a Measure of Safety and Tolerability		baseline and 14 +- 3 days
Investigational product wear time	The patient will complete his patient diary after each Investigational Product removal	14 +- 3 days
Investigational product adhesivity as measured by a Likert scale score (1-4)		14 +- 3 days
Investigational product flexibility as measured by a Likert scale score (1-4)		14 +- 3 days
Investigational product conformability as measured by a Likert scale score (1-4)		14 +- 3 days
Convex ring suppleness of the Investigational product as measured by a Likert scale score (1-4)		14 +- 3 days
Connection of the Investigational Product belt to the belt hear as measured by a Likert scale score (1-4)		14 +- 3 days
Residues on the skin after each Investigational Product removal as measured by a Likert scale score (1-4)		14 +- 3 days
Ease of Investigational Product handling as measured by a Likert scale score (1-4)		14 +- 3 days
Investigational Product wearing comfort as measured by a Likert scale score (1-4)		14 +- 3 days
Investigational Product leakage prevention as measured by a Likert scale score (1-4)		14 +- 3 days
Feeling of Investigational Product security as measured by a Likert scale score (1-4)		14 +- 3 days
Investigational Product overall satisfaction as measured by a Likert scale score (1-4)		14 +- 3 days
Use of Investigational Product in the future as measured by a Likert scale score (1-2)		14 +- 3 days

Collaborators and Investigators

• Sponsor: BBraun Medical SAS
• Investigators: Principal Investigator: Patrick RAT, MD, University Hospital of Dijon

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (Actual): September 1, 2016
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: July 3, 2015
• First Submitted That Met QC Criteria: July 23, 2015
• First Posted (Estimate): July 24, 2015

Study Record Updates

• Last Update Posted (Estimate): September 23, 2016
• Last Update Submitted That Met QC Criteria: September 22, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: OPM-G-H-1501