PDF(Pubmed)
Abstract：
Despite differing etiologies, acute thermal burn injuries and full-thickness (FT) skin defects are associated with similar therapeutic challenges. When not amenable to primary or secondary closure, the conventional standard of care (SoC) treatment for these wound types is split-thickness skin grafting (STSG). This invasive procedure requires adequate availability of donor skin and is associated with donor site morbidity, high healthcare resource use (HCRU), and costs related to prolonged hospitalization. As such, treatment options that can facilitate effective healing and donor skin sparing have been highly anticipated. The RECELL® Autologous Cell Harvesting Device facilitates preparation of an autologous skin cell suspension (ASCS) for the treatment of acute thermal burns and FT skin defects. In initial clinical trials, the approach showed superior donor skin-sparing benefits and comparable wound healing to SoC STSG among patients with acute thermal burn injuries. These findings led to approval of RECELL for this indication by the US Food and Drug Administration (FDA) in 2018. Subsequent clinical evaluation in non-thermal FT skin wounds showed that RECELL, when used in combination with widely meshed STSG, provides donor skin-sparing advantages and comparable healing outcomes compared with SoC STSG. As a result, the device received FDA approval in June of 2023 for treatment of FT skin defects caused by traumatic avulsion or surgical excision or resection. Given that health economic advantages have been demonstrated for RECELL ± STSG versus STSG alone when used for burn therapy, it is prudent to examine similarities in the burn and FT skin defect treatment pathways to forecast the potential health economic advantages for RECELL when used in FT skin defects. This article discusses the parallels between the two indications, the clinical outcomes reported for RECELL, and the HCRU and cost benefits that may be anticipated with use of the device for non-thermal FT skin defects.
摘要：
尽管病因不同，急性热烧伤和全厚度（FT）皮肤缺损与类似的治疗挑战有关。当不适合主要或次要关闭时，这些伤口类型的常规护理标准(SoC)治疗是分层厚度皮肤移植(STSG)。这种侵入性手术需要供体皮肤的足够可用性，并且与供体部位的发病率有关。高医疗保健资源使用(HCRU)，以及与长期住院有关的费用。因此，可以促进有效愈合和供体皮肤保留的治疗选择已被高度预期。RECELL®自体细胞收获装置有助于制备用于治疗急性热烧伤和FT皮肤缺损的自体皮肤细胞悬浮液(ASCS)。在最初的临床试验中，该方法在急性热烧伤患者中显示出较好的供体皮肤保护益处和与SoCSTSG相当的伤口愈合.这些发现导致2018年美国食品和药物管理局（FDA）批准了RECell的这一适应症。随后的非热FT皮肤伤口的临床评估显示，当与广泛网格的STSG结合使用时，与SoCSTSG相比，提供供体皮肤保护优势和可比的愈合效果。因此,该装置于2023年6月获得FDA批准,用于治疗由创伤性撕脱或手术切除或切除引起的FT皮肤缺损.鉴于已证明RECell±STSG与单独用于烧伤治疗时的STSG具有健康经济优势，谨慎的做法是检查烧伤和FT皮肤缺损治疗途径的相似性,以预测用于FT皮肤缺损时RECell的潜在健康经济优势.本文讨论了两种适应症之间的相似之处，RECell报告的临床结果，以及HCRU和使用该装置可预期的非热FT皮肤缺损的成本效益。
