Clinical trial NCT04030832: Reconstruction of Skin Substance Loss With "Micro-grafts" Obtained by Mechanical Disintegration
Official title: Reconstruction of Skin Substance Loss With Method of "Micro-grafts" Obtained by Mechanical Disintegration: Preliminary Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cutaneous Ulcer
Trauma Injury
Lead sponsor: Azienda Ospedaliero, Universitaria Ospedali Riuniti
Sponsor class: OTHER
First posted: 2019-07-24
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who attend the various regional hospitals through the emergency room or surgical clinic

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Full-thickness skin loss from a minimum size of 3x3 cm (9cm2) to a maximum size of 5x5 cm (25cm2);
* Loss of substance caused by abrasive-contusive traumas (loss of full-thickness skin substance) or by thermal burn (deep degree II), present for at least 15 days;
* Absence of clinical signs of infection assessed by two culture swabs performed at T0 (pre and post debridement);
* Pre-operative inflammatory index (VES, PCR) and b-hcg negative;
* Absence of exposure of osteo-cartilaginous structures, of noble structures (major arterial vessels, major nerve trunks, tendons without paratenon);
* Specific written informed consent

Exclusion Criteria:

* Smoking patients (≥ 10 cigarettes / day);
* Patients with type I or type II diabetes mellitus:
* Patients suffering vascular trophic ulcers;
* Patients with loss of substance at the level of the fingers and toes;
* Patients with loss of substance of the foot and the yarrow region;
* Patients with oncological pathologies in progress or in remission;
* Patients in therapy with immunosuppressive and corticosteroid drugs, anticoagulants, antiplatelet agents;
* Patients with autoimmune diseases including connectivitis;
* Patients with congenital, acquired and metabolic immunodeficiencies;
* Pregnant patients (ascertained with β-HCG) and breastfeeding.

Primary outcomes:
measure: Wound Bed Score values
timeFrame: change of baseline wound bed score values at day 30
Secondary outcomes:
measure: Spontaneous re-epithelialization.
timeFrame: Day 0 and Day 30
measure: Vancouver scale
timeFrame: Day 30, Day 90 and Day 180
Other outcomes:
Locations:
city: Ancona
country: Italy
facility: Azienda Ospedaliera Universitaria Ospedali Riuniti
state: AN
city: Milan
country: Italy
facility: IRCCS Policlinico San Donato
state: MI
city: Udine
country: Italy
facility: Università degli Studi di Udine
state: UD
city: Roma
country: Italy
facility: Università degli Studi di Roma "La Sapienza"
Study officials:
References:
citation: Greaves NS, Ashcroft KJ, Baguneid M, Bayat A. Current understanding of molecular and cellular mechanisms in fibroplasia and angiogenesis during acute wound healing. J Dermatol Sci. 2013 Dec;72(3):206-17. doi: 10.1016/j.jdermsci.2013.07.008. Epub 2013 Jul 30.
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