Status:
COMPLETED
Reconstruction of Skin Substance Loss With "Micro-grafts" Obtained by Mechanical Disintegration
Lead Sponsor:
Azienda Ospedaliero, Universitaria Ospedali Riuniti
Conditions:
Cutaneous Ulcer
Trauma Injury
Eligibility:
All Genders
18-70 years
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 ...
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 prima...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 30 2019
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT04030832
Start Date
October 1 2017
End Date
June 30 2019
Last Update
July 24 2019
Active Locations (4)
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1
Azienda Ospedaliera Universitaria Ospedali Riuniti
Ancona, AN, Italy, 60126
2
IRCCS Policlinico San Donato
Milan, MI, Italy
3
Università degli Studi di Udine
Udine, UD, Italy
4
Università degli Studi di Roma "La Sapienza"
Roma, Italy