Trauma Injury Clinical Trial
Official title:
Reconstruction of Skin Substance Loss With Method of "Micro-grafts" Obtained by Mechanical Disintegration: Preliminary Study
The etiology of non-healing ulcers depends on both systemic and local factors. The introduction of advanced dressing, negative wound therapy and compression therapy have undoubtedly improved clinical outcomes. The principal aim of study was to demonstrate the efficacy of skin micrografts in the treatment of skin substance loss.
The principal aim of study was to evaluate the efficacy of skin micro-grafts obtained with
the system of mechanical disintegration in the reconstruction of skin substance loss in the
limbs.
The primary endpoint consists in evaluating, through a specific evaluation scale, the Wound
Bed Score (WBS) for skin substance loss at Time 0 (T0) and 30 days after the procedure (T30)
and to evaluate the increase of this score in this time frame set at 50%. The evaluation will
be carried out in double blind.
The secondary endpoints instead consist in the evaluation of the Wound Surface Area
Assessment to be carried out at T0 and T30.
In the evaluation of the quality of the resulting scars, through the Vancouver Scale (VS), 90
(T90) and 180 days (T180) after treatment and to evaluate the reduction of this score by 15%;
on the other in the evaluation of the progress of the Visual Analogic Scale (VAS)
administered to the patient at T0, 30, 90, 180.
The purpose of this minimally invasive treatment is to improve the quality of life of those
affected by these injuries, avoiding the use of prolonged advanced medications and / or more
invasive surgical procedures, thus speeding up healing and favoring the clinical outcome of
patients.
No chemical reagents or enzymes are used for the method. There is therefore no tissue
manipulation, in full compliance with the European directive 23/2004.
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