Report of outcomes in burn patients enrolled in the Cultured epidermal autograft prospective Registry

Abstract

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 18children) 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.