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

NCT04030832 | Completed

• 1 other identifier: MICROINNESTI-1
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 4

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.

Conditions

Cutaneous Ulcer; Trauma Injury

Outcome Measures

Primary Outcomes (1)

• Wound Bed Score values

  Percentage of patients with change of the Wound Bed Score values higher than 50%, after 30 days,

  change of baseline wound bed score values at day 30

Secondary Outcomes (2)

• Spontaneous re-epithelialization.

  Day 0 and Day 30

• Vancouver scale

  Day 30, Day 90 and Day 180

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients who attend the various regional hospitals through the emergency room or surgical clinic

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Azienda Ospedaliero, Universitaria Ospedali Riuniti: lead

Study Sites (4)

Azienda Ospedaliera Universitaria Ospedali Riuniti

Ancona, AN, 60126, Italy

Location

IRCCS Policlinico San Donato

Milan, MI, Italy

Location

Università degli Studi di Udine

Udine, UD, Italy

Location

Università degli Studi di Roma "La Sapienza"

Roma, Italy

Location

Related Publications (10)

• 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.

  PMID: 23958517 RESULT

• 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.

  PMID: 25728337 RESULT

• 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.

  PMID: 27126653 RESULT

• 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.

  PMID: 26976986 RESULT

• 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.

  PMID: 26825041 RESULT

• 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.

  PMID: 27738884 RESULT

• 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.

  PMID: 17199681 RESULT

• 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.

  PMID: 27859908 RESULT

• 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.

  PMID: 8537427 RESULT

• 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.

  PMID: 28767054 RESULT

MeSH Terms

Conditions

Skin Ulcer; Accidental Injuries

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Wounds and Injuries

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: July 17, 2019
• First Posted: July 24, 2019
• Study Start: October 1, 2017
• Primary Completion: October 1, 2018
• Study Completion: June 30, 2019
• Last Updated: July 24, 2019

Record last verified: 2019-07

Locations

IT (4)