Reconstruction of Skin Substance Loss With "Micro-grafts" Obtained by Mechanical Disintegration

Completed

• Conditions: Cutaneous Ulcer; Trauma Injury

• Registration Number: NCT04030832
• Lead Sponsor: Azienda Ospedaliero, Universitaria Ospedali Riuniti

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.

Study Timeline

• Study Start: 2017-10-01
• Primary Completion: 2018-10-01
• Study Completion: 2019-06-30
• Status Verified: 2019-07
• Study First Submitted: 2019-07-17
• Study First Submitted QC: 2019-07-23
• Last Update Submitted: 2019-07-23
• Study First Posted: 2019-07-24
• Last Update Posted: 2019-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Wound Bed Score values	change of baseline wound bed score values at day 30	Percentage of patients with change of the Wound Bed Score values higher than 50%, after 30 days,

Secondary Outcome Measures

Name	Time	Method
Vancouver scale	Day 30, Day 90 and Day 180	Percentage of patients with change of Vancouver scale values higher than 15%
Spontaneous re-epithelialization.	Day 0 and Day 30	Percentage of patients with spontaneous re-epithelialization of the total wound surface, after 30 days, as assessed by Wound Surface Area Assessment

Trial Locations

Locations (4)

Azienda Ospedaliera Universitaria Ospedali Riuniti; 🇮🇹 Ancona, AN, Italy

Università degli Studi di Roma "La Sapienza"; 🇮🇹 Roma, Italy

IRCCS Policlinico San Donato; 🇮🇹 Milan, MI, Italy

Università degli Studi di Udine; 🇮🇹 Udine, UD, Italy