This investigation is a Post Marketing Follow-Up Study for Mepilex XT conducted as part of Mölnlycke Health Care's quality system. The primary objective is to evaluate the performance of the dressing when used as intended on exuding Venous Leg Ulcers (VLUs) in the inflammatory and granulating stages of the wound healing process.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Experimental arm
Nemocnice Podlesí a.s.
Třinec, Konská 453, Czechia
Nemocnice Jihlava
Jihlava, Vrchlického, Czechia
The General University Hospital in Prague
Prague, Czechia
Changes From Baseline in Condition of the Peri Wound Skin
Deteriorationin of skin condition , Mepilex XT and Standard care (%)
Time frame: 16 weeks
Pain Scores on the Visual Analog Scale
Pain at baseline visit, compared with pain at week 16. VAS scale, minimum pain = 0, maximum pain = 100.
Time frame: 16 weeks
Users Feedback After Handling or Use as a Measure of Performance.
Investigator/Nurse and Subject evaluation of performance of the primary dressing ( n) Scale= Good , Very Good, Poor, Very Poor 1Ease of application, 2 Ease of removal, 3 Ability to retain exudate, 4 Adherence to healthy skin, 5 Confomability to be repositioned , 6 Overall satisfaction, 7 Dressing sticking to wound bed, 8 Presence of residues on the wound bed. 9 Presence of residues on the healthy skin. 10 Overall evaluation of change in periwound skin condition.
Time frame: 16 weeks
Measure of Actual Dressing Cost and Cost of Care, as Input for Health Economics Calculations.
Time frame: 16 weeks
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