Melandri Davide, Marongiu Francesco, Carboni Andrea, Rubino Corrado, Razzano Sergio, Purpura Valeria, Minghetti Paola, Bondioli Elena
M Bufalini Hospital, Cesena, Italy.
Azienda USL della Romagna, Italy.
Int J Low Extrem Wounds. 2020 Mar;19(1):78-85. doi: 10.1177/1534734619884422. Epub 2019 Nov 4.
The closure of wounds associated with soft tissue defects is surgically challenging, frequently requiring extensive plastic surgery and free flaps. The combination of ADM and STSG is an innovative method used to cover such wounds. The human-derived ADMs (H-ADMs) are the most described in the literature but according to European legislations, Companies H-ADMs outside the EC are not allowed to commercialize them in Europe, H-ADMs being "human products" and not "medical devices", so being ruled by European legislations on transplants. The Skin Bank of the Bufalini Hospital (Cesena, Italy) obtained in 2009 the approval for the production and distribution of the first human cadaver-donor derived ADM from the Italian National Transplant Center and National Health Institute, we called with the Italian acronym M.O.D.A. (Matrice Omologa Dermica Acellulata). We present here the first use of a new H-ADM for treatment of distal lower extremity wounds with exposed tendons managed in one-stage pocedure with STSG. The excellent performance suggests that in cases where autologous tissue is unavailable or undesirable, the use of M.O.D.A. in one-stage procedure represents a promising alternative for covering wounds associated with tendons exposition.
与软组织缺损相关的伤口闭合在手术上具有挑战性,通常需要进行广泛的整形手术和游离皮瓣移植。脱细胞真皮基质(ADM)与自体薄皮片(STSG)联合使用是一种用于覆盖此类伤口的创新方法。文献中对人源ADM(H-ADM)的描述最多,但根据欧洲法规,欧盟以外公司生产的H-ADM在欧洲不允许商业化,因为H-ADM是“人类产品”而非“医疗器械”,因此受欧洲移植法规的约束。意大利切塞纳市布法利尼医院的皮肤库于2009年获得了意大利国家移植中心和国家卫生研究所的批准,可生产和分发首个源自人类尸体供体的ADM,我们用意大利首字母缩写M.O.D.A.(无细胞真皮同源基质)来称呼它。在此,我们展示了一种新型H-ADM首次用于治疗伴有肌腱外露的下肢远端伤口,采用与自体薄皮片联合的一期手术方法。出色的治疗效果表明,在自体组织不可用或不理想的情况下,一期手术中使用M.O.D.A.是覆盖伴有肌腱外露伤口的一种有前景的替代方法。