This study evaluates the performance of a new 1-piece ostomy convex appliance in patients with enterostomy.
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
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
The Investigational Device will be used during 14 +- 3 days.
Patrick RAT
Dijon, France
Flexima® Active Soft Convex ostomy appliance performance description in term of level of leakage under the skin protector
Time frame: 14 +- 3 days
Peristomal skin evaluation with DET score scale
Time frame: baseline and 14 +- 3 days
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: baseline and 14 +- 3 days
Investigational product wear time
The patient will complete his patient diary after each Investigational Product removal
Time frame: 14 +- 3 days
Investigational product adhesivity as measured by a Likert scale score (1-4)
Time frame: 14 +- 3 days
Investigational product flexibility as measured by a Likert scale score (1-4)
Time frame: 14 +- 3 days
Investigational product conformability as measured by a Likert scale score (1-4)
Time frame: 14 +- 3 days
Convex ring suppleness of the Investigational product as measured by a Likert scale score (1-4)
Time frame: 14 +- 3 days
Connection of the Investigational Product belt to the belt hear as measured by a Likert scale score (1-4)
Time frame: 14 +- 3 days
Residues on the skin after each Investigational Product removal as measured by a Likert scale score (1-4)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 14 +- 3 days
Ease of Investigational Product handling as measured by a Likert scale score (1-4)
Time frame: 14 +- 3 days
Investigational Product wearing comfort as measured by a Likert scale score (1-4)
Time frame: 14 +- 3 days
Investigational Product leakage prevention as measured by a Likert scale score (1-4)
Time frame: 14 +- 3 days
Feeling of Investigational Product security as measured by a Likert scale score (1-4)
Time frame: 14 +- 3 days
Investigational Product overall satisfaction as measured by a Likert scale score (1-4)
Time frame: 14 +- 3 days
Use of Investigational Product in the future as measured by a Likert scale score (1-2)
Time frame: 14 +- 3 days