Reconstruction of Skin Substance Loss With "Micro-grafts" Obtained by Mechanical Disintegration
NCT ID: NCT04030832
Last Updated: 2019-07-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
70 participants
OBSERVATIONAL
2017-10-01
2019-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
70 Years
ALL
No
Sponsors
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Azienda Ospedaliero, Universitaria Ospedali Riuniti
OTHER
Responsible Party
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Michele Riccio
Director
Locations
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Azienda Ospedaliera Universitaria Ospedali Riuniti
Ancona, AN, Italy
IRCCS Policlinico San Donato
Milan, MI, Italy
Università degli Studi di Udine
Udine, UD, Italy
Università degli Studi di Roma "La Sapienza"
Roma, , Italy
Countries
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References
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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.
Trovato L, Monti M, Del Fante C, Cervio M, Lampinen M, Ambrosio L, Redi CA, Perotti C, Kankuri E, Ambrosio G, Rodriguez Y Baena R, Pirozzi G, Graziano A. A New Medical Device Rigeneracons Allows to Obtain Viable Micro-Grafts From Mechanical Disaggregation of Human Tissues. J Cell Physiol. 2015 Oct;230(10):2299-303. doi: 10.1002/jcp.24973.
Marcarelli M, Trovato L, Novarese E, Riccio M, Graziano A. Rigenera protocol in the treatment of surgical wound dehiscence. Int Wound J. 2017 Feb;14(1):277-281. doi: 10.1111/iwj.12601. Epub 2016 Apr 29.
Baglioni E, Trovato L, Marcarelli M, Frenello A, Bocchiotti MA. Treatment of Oncological Post-surgical Wound Dehiscence with Autologous Skin Micrografts. Anticancer Res. 2016 Mar;36(3):975-9.
Svolacchia F, De Francesco F, Trovato L, Graziano A, Ferraro GA. An innovative regenerative treatment of scars with dermal micrografts. J Cosmet Dermatol. 2016 Sep;15(3):245-53. doi: 10.1111/jocd.12212. Epub 2016 Jan 30.
De Francesco F, Graziano A, Trovato L, Ceccarelli G, Romano M, Marcarelli M, Cusella De Angelis GM, Cillo U, Riccio M, Ferraro GA. A Regenerative Approach with Dermal Micrografts in the Treatment of Chronic Ulcers. Stem Cell Rev Rep. 2017 Feb;13(1):139-148. doi: 10.1007/s12015-016-9692-2.
Falanga V, Saap LJ, Ozonoff A. Wound bed score and its correlation with healing of chronic wounds. Dermatol Ther. 2006 Nov-Dec;19(6):383-90. doi: 10.1111/j.1529-8019.2006.00096.x.
Qi X, Ding L, Huang W, Wen B, Guo X, Zhang J. An improved automated type-based method for area assessment of wound surface. Wound Repair Regen. 2017 Jan;25(1):150-158. doi: 10.1111/wrr.12495. Epub 2017 Jan 25.
Baryza MJ, Baryza GA. The Vancouver Scar Scale: an administration tool and its interrater reliability. J Burn Care Rehabil. 1995 Sep-Oct;16(5):535-8. doi: 10.1097/00004630-199509000-00013.
Jimi S, Kimura M, De Francesco F, Riccio M, Hara S, Ohjimi H. Acceleration Mechanisms of Skin Wound Healing by Autologous Micrograft in Mice. Int J Mol Sci. 2017 Aug 2;18(8):1675. doi: 10.3390/ijms18081675.
Other Identifiers
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MICROINNESTI-1
Identifier Type: -
Identifier Source: org_study_id
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