Bosque Brandon A, Dowling Shane G, May Barnaby C H, Kaufman Richard, Zilberman Igor, Zolfaghari Nooshin, Que Howie, Longobardi James, Skurka Joseph, Geiger James E, Melin M Mark
*Aroa Biosurgery, Research and Clinical Development, San Diego, CA.
†Ankle and Foot Centers of America, Roswell, GA.
J Am Podiatr Med Assoc. 2023 May-Jun;113(3). doi: 10.7547/22-081.
Chronic lower-extremity defects may lead to major amputations and have severe consequences on patient quality of life and mortality. Dermal matrices have become part of the reconstructive ladder and are often deployed in these scenarios to quickly build neodermis, especially in volumetric defects over exposed bone and tendon initially, to allow for subsequent closure by means of split-thickness skin grafting (STSG) or secondary intention. Ovine forestomach matrix (OFM) is a decellularized extracellular matrix (ECM) bioscaffold available in both sheet and particulate forms that can be used as a dermal matrix in various soft-tissue reconstruction procedures.
This retrospective case series evaluated the use of OFM products in the surgical reconstruction of 50 cases (n = 50) comprised of challenging lower-extremity defects from seven healthcare centers. Patient records were reviewed to identify comorbidities, defect cause, defect size, presence of exposed structures, Centers for Disease Control and Prevention contamination score, Wagner grade, OFM graft use, time to 100% granulation tissue, STSG use, overall time to heal, and postoperative complications. The primary study outcomes were time (days) to 100% granulation tissue formation, with secondary outcomes including overall time to wound closure (weeks), STSG take at 1 week, and complications.
The results of this case series demonstrate OFM as a clinically effective treatment in the surgical management of complex lower-extremity soft-tissue defects with exposed structures in patients with multiple comorbidities. One application of OFM products was effective in regenerating well-vascularized neodermis, often in the presence of exposed structures, with a mean time to 100% granulation of 26.0 ± 22.2 days.
These data support the use of OFM as a safe, cost-effective, and clinically effective treatment option for coverage in complex soft-tissue wounds, including exposed vital structures, and to shorten the time to definitive wound closure in complicated patient populations.
慢性下肢缺损可能导致大截肢，并对患者的生活质量和死亡率产生严重影响。真皮基质已成为重建阶梯的一部分，常用于此类情况以快速构建新真皮，特别是最初用于覆盖暴露骨骼和肌腱的大面积缺损，以便随后通过断层皮片移植（STSG）或二期愈合进行闭合。羊前胃基质（OFM）是一种脱细胞细胞外基质（ECM）生物支架，有片状和颗粒状两种形式，可在各种软组织重建手术中用作真皮基质。
本回顾性病例系列评估了OFM产品在7个医疗中心对50例具有挑战性的下肢缺损患者进行手术重建中的应用。回顾患者记录以确定合并症、缺损原因、缺损大小、暴露结构的存在、疾病控制与预防中心污染评分、瓦格纳分级、OFM移植物使用情况、达到100%肉芽组织形成的时间、STSG使用情况、总体愈合时间和术后并发症。主要研究结果是达到100%肉芽组织形成的时间（天），次要结果包括伤口闭合的总体时间（周）、1周时STSG的成活情况和并发症。
本病例系列结果表明，OFM在合并多种疾病且有暴露结构的复杂下肢软组织缺损的手术治疗中是一种临床有效的治疗方法。OFM产品单次应用通常能在存在暴露结构的情况下有效再生血管丰富的新真皮，达到100%肉芽组织形成的平均时间为26.0±22.2天。
这些数据支持将OFM作为一种安全、经济有效且临床有效的治疗选择，用于覆盖复杂软组织伤口，包括暴露的重要结构，并缩短复杂患者群体确定性伤口闭合的时间。
