109 Demonstration of the Safety and Effectiveness of Autologous Skin Cell Suspension Combined with Meshed Skin Grafts for the Reduction of Donor Area in the Treatment of Acute Burns

Split-thickness autografts (STAG) are the standard of care for definitive coverage of burns requiring grafting. However, STAG are often complicated by scarring, dyspigmentation, and limited donor skin. Cell suspension systems are potential alternatives/adjuncts to STAG. ReCell® is a device for point-of-care preparation and application of non-cultured, autologous skin cells that provides an expansion ratio of 80:1. Currently, ReCell® is limited by US law to investigational use only. We present the results of the confirmatory FDA approval trial for ReCell®. This was a prospective, randomized, within-patient controlled, GCP-compliant, FDA IDE trial in patients >4 yoa who sustained 5–50% TBSA thermal burns requiring STAG. Comparable burns, including 3rd degree, measuring >300 cm2 were randomized to either treatment with widely meshed STAG+ReCell® over-spray or STAG alone meshed at the surgeon’s discretion (control). The surgeon chose a meshing ratio ≤3:1 for the control before randomization, and then the ReCell® wound was autografted with the next higher ratio and over-sprayed. Co-primary effectiveness endpoints evaluated the relative reduction in donor area (superiority) and recipient site healing at 8 weeks (non-inferiority) between the ReCell® and control wounds. Secondary effectiveness endpoints included subject satisfaction and POSAS scores. Safety endpoints included infection, pain, durability, scarring, and adverse events. Data were analysed by intention-to-treat (ITT) and per-protocol (PP) populations, as appropriate. A total of 30 subjects across 6 US Burn Centers were enrolled (n=30 ITT, n=26 PP). The ReCell® and control wounds were similar in size (555 ± 378 vs. 528 ± 312 cm2, p=NS), but mean donor areas were significantly reduced with ReCell® use (271 ± 124 vs. 368 ± 150 cm2, p<0.001). The superiority effectiveness endpoint was met for ReCell® wounds in the ITT population, demonstrating a significant reduction in donor skin required, and the non-inferiority effectiveness endpoint was met in the PP population for ReCell® vs. control healing. Secondary effectiveness endpoints were similar between ReCell® and control wounds. No demonstrable safety signal was generated. ReCell® is an autograft sparing technology that can be used safely as an adjunct to STAG for treating acute thermal burns that require grafting, with a significant reduction in the amount of donor skin, equivalent wound closure, and comparable scarring outcomes when compared to conventional STAG. ReCell® allows the burn surgeon to “graft” a burn with less skin than with conventional STAG, resulting in comparable healing and scarring outcomes.