Clinical trial NCT02507726: Multicenter and Open Pilot Clinical Study on the Safety of a New One-piece Convex Appliance in Patients With Enterostomy
Official title: Multicenter and Open Pilot Clinical Study on the Safety of a New One-piece Convex Appliance in Patients With Enterostomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Enterostomy
Lead sponsor: BBraun Medical SAS
Sponsor class: INDUSTRY
First posted: 2015-07-24
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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

Eligibility criteria: 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

Primary outcomes:
measure: Flexima® Active Soft Convex ostomy appliance performance description in term of level of leakage under the skin protector
timeFrame: 14 +- 3 days
Secondary outcomes:
measure: Peristomal skin evaluation with DET score scale
timeFrame: baseline and 14 +- 3 days
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: baseline and 14 +- 3 days
measure: Investigational product wear time
timeFrame: 14 +- 3 days
measure: Investigational product adhesivity as measured by a Likert scale score (1-4)
timeFrame: 14 +- 3 days
measure: Investigational product flexibility as measured by a Likert scale score (1-4)
timeFrame: 14 +- 3 days
measure: Investigational product conformability as measured by a Likert scale score (1-4)
timeFrame: 14 +- 3 days
measure: Convex ring suppleness of the Investigational product as measured by a Likert scale score (1-4)
timeFrame: 14 +- 3 days
measure: Connection of the Investigational Product belt to the belt hear as measured by a Likert scale score (1-4)
timeFrame: 14 +- 3 days
measure: Residues on the skin after each Investigational Product removal as measured by a Likert scale score (1-4)
timeFrame: 14 +- 3 days
measure: Ease of Investigational Product handling as measured by a Likert scale score (1-4)
timeFrame: 14 +- 3 days
measure: Investigational Product wearing comfort as measured by a Likert scale score (1-4)
timeFrame: 14 +- 3 days
measure: Investigational Product leakage prevention as measured by a Likert scale score (1-4)
timeFrame: 14 +- 3 days
measure: Feeling of Investigational Product security as measured by a Likert scale score (1-4)
timeFrame: 14 +- 3 days
measure: Investigational Product overall satisfaction as measured by a Likert scale score (1-4)
timeFrame: 14 +- 3 days
measure: Use of Investigational Product in the future as measured by a Likert scale score (1-2)
timeFrame: 14 +- 3 days
Other outcomes:
Locations:
city: Dijon
country: France
facility: Patrick RAT
Study officials:
affiliation: University Hospital of Dijon
name: Patrick RAT, MD
role: PRINCIPAL_INVESTIGATOR
References: