培养表皮自体移植前瞻性登记处登记的烧伤患者疗效报告

Shawn Fagan , Zaheed Hassan , Bounthavy Homsombath , Rajiv Sood , Kade Hardy , Beretta Craft-Coffman , Brett C. Hartman , Caryn Cramer , John Griswold
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引用次数: 0

摘要

培养表皮自体移植(CEA)是一种永久性皮肤替代物,适用于体表总面积(TBSA)≥30%的成人和儿童深层真皮烧伤或全厚度烧伤患者。2007年,CEA(Epicel®)作为人道主义使用设备(HUD)获得人道主义设备豁免(HDE),获准在美国用于成人,并于2016年获准用于儿童。2019 年,CEA 注册中心成立,目的是前瞻性地收集和分析 CEA 实际使用过程中的人口统计学、治疗和结果数据。在数据截止时(2022 年 6 月),有 68 名患者(50 名成人和 18 名儿童)完成了登记数据,直至出院,供本分析使用。成人和儿童患者烧伤的平均体表总面积(TBSA)分别为 58% 和 56%,每组患者中几乎一半都有吸入性损伤。约 74% 的成人和 67% 的儿童患者的总体表面积≥ 50%。总存活率为 87%(成人 84%,儿童 94%)。成人和儿童患者的 CEA 平均移植物吸收(移植)率分别为 81% 和 84%。这一前瞻性数据收集结果表明,采用 CEA 治疗严重烧伤患者的移植率和存活率都很高,与近期文献的结果基本一致。
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Report of outcomes in burn patients enrolled in the Cultured epidermal autograft prospective Registry

Cultured epidermal autograft (CEA) is a permanent skin replacement indicated for use in adult and pediatric patients with deep dermal or full thickness burns comprising a total body surface area (TBSA) ≥ 30 %. CEA (Epicel®) was approved for use in adults in the United States in 2007 as a Humanitarian Use Device (HUD) under a Humanitarian Device Exemption (HDE) and was approved for pediatric use in 2016. In 2019, a CEA Registry was established with an objective of prospective data collection and analysis of demographic, treatment, and outcome data for the real-world use of CEA. At the time of data cut–off (June 2022), 68 patients (50 adults and 18 children) had completed data in the registry, up through hospital discharge, for this analysis. Mean total body surface area (TBSA) of the burn was 58 % in adults and 56 % in pediatric patients, and almost half had inhalation injury in each group. Approximately 74 % of adults and 67 % of pediatric patients had TBSA ≥ 50 %. Overall survival was 87 % (84 % adults, 94 % pediatric). Mean % graft take (engraftment) of CEA was 81 % in adults and 84 % in pediatric patients. Outcomes from this prospective collection of data in severely burned patients treated with CEA demonstrate favorable engraftment and survival rates and are in general agreement with recent literature.

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