The primary objective of this post market clinical follow-up (PMCF) investigation is to evaluate performance and safety of Exufiber when used as intended in Stage II-IV pressure ulcers (PU).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
21
Dermatologie Campus Kennedylaan
Kortrijk, Kortrijk, Belgium
Dep. of Plastic Surgery UZ Bruzzel
Brussels, Belgium
University Hospital Gent, Belgium
Ghent, Belgium
Töölö Hospital
Helsinki, Finland
Number of Participants With Worsening in Peri-Skin Wound.(Maceration From Baseline to 6 Weeks)
the subjects will be measured by the following variables; maceration,
Time frame: 6 weeks
Evaluate the Level of Pain at Week 6 Changes in Wound Status, Clinician's and Subject's Opinion, and Technical Performance
Pain during product removal at week 6, measured by Visual Analog scale.This will be measured by the following variables; visual analog scale, 0=no pain, 100= worst pain, scale from 0-100 mm
Time frame: 6 weeks
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