Reconstruction of Skin Substance Loss With "Micro-grafts" Obtained by Mechanical Disintegration (MG-1)
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|ClinicalTrials.gov Identifier: NCT04030832|
Recruitment Status : Completed
First Posted : July 24, 2019
Last Update Posted : July 24, 2019
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|Condition or disease|
|Cutaneous Ulcer Trauma Injury|
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 Type :||Observational|
|Actual Enrollment :||70 participants|
|Official Title:||Reconstruction of Skin Substance Loss With Method of "Micro-grafts" Obtained by Mechanical Disintegration: Preliminary Study|
|Actual Study Start Date :||October 1, 2017|
|Actual Primary Completion Date :||October 1, 2018|
|Actual Study Completion Date :||June 30, 2019|
- Wound Bed Score values [ Time Frame: 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,
- Spontaneous re-epithelialization. [ Time Frame: 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
- Vancouver scale [ Time Frame: Day 30, Day 90 and Day 180 ]Percentage of patients with change of Vancouver scale values higher than 15%
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|Ages Eligible for Study:||18 Years to 70 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Probability Sample|
- 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
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04030832
|Azienda Ospedaliera Universitaria Ospedali Riuniti|
|Ancona, AN, Italy, 60126|
|IRCCS Policlinico San Donato|
|Milan, MI, Italy|
|Università degli Studi di Udine|
|Udine, UD, Italy|
|Università degli Studi di Roma "La Sapienza"|
|Responsible Party:||Michele Riccio, Director, Azienda Ospedaliero, Universitaria Ospedali Riuniti|
|Other Study ID Numbers:||
|First Posted:||July 24, 2019 Key Record Dates|
|Last Update Posted:||July 24, 2019|
|Last Verified:||July 2019|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|