498 Healing of Donor Sites with an Autologous Skin Cell Suspension for Large TBSA Burn Injuries: A Prospective Evaluation

Current treatment for burn injuries is the use of split-thickness skin grafts (STSG), however this treatment is often limited by donor site availability and requires reharvesting of donor sites to obtain definitive closure. In uncompromised patients it can take 7-14 days to heal, and for patients with severe injuries, this time can be delayed. The RECELL® System is a point-of-care device that allows for the preparation and application of non-cultured, autologous skin cells; however the safety and effectiveness has not been established for use in the treatment of donor sites. This study presents the use of autologous skin cell suspension (ASCS), prepared using the RECELL® System for the treatment of donor sites in patients enrolled in a prospective uncontrolled observational study (IDE 15945—NCT02992249) with life-threatening burn injuries. Following harvesting of STSGs, ASCS was applied to the donor site. Clinical outcomes were evaluated up to one year including percentage of re-epithelialization, long-term cosmetic outcomes, and adverse events. Seventy-three patients from 15 burn centers had their donor sites treated with ASCS as part of their treatment regimen. The average subject age was 29 and the average TBSA injury was 54.1 ±16.5%. The mean Baux score was 84.3 with 32% of subjects having a score greater than 100. Collectively, 430 donor sites were individually treated. In this compromised patient population 45.5% were ≥95% re-epithelialized by week 1 (n=345), and by week 2, 91% of the donor sites were ≥95% re-epithelialized (n=277), regardless of times harvested. Approximately 20% of the donor sites treated with ACSC were reharvested multiple times following initial healing (3.5% three times, and two donor sites were harvested four times) and retreated. Of donor sites harvested more than once, 51.6% (n=62), 84.6% (n=66), and 96.4% (n=55) of sites were ≥ 95% re-epithelialized by week 1, 2 and 4, respectively. One-year data was available for 300 donor sites and the majority had matched or mildly mismatched color, pigment, and texture. Adverse events included one site with a hematoma and one patient with donor sites that had fragile skin loss secondary to traumatic friction. There were no other instances of infection or delayed healing. ASCS has been successfully used to achieve closure of donor site wounds without infection or delayed healing in patients with extensive burn injuries. Application of ASCS for donor site healing may be particularly applicable for patients requiring subsequent reharvesting to achieve definitive closure.