124 Autologous Skin Cell Suspension Achieves Closure of Donor Site Wounds Facilitating Early Re-harvesting for Large TBSA burn Injuries

Abstract

Abstract Introduction Management of extensive burn injuries is complicated often resulting in significant morbidity and mortality. Current standard of care includes use of split-thickness skin grafts (STSG) to obtain definitive closure; however, this treatment is often limited by donor site availability, which requires repeated re-harvesting of donor sites to obtain definitive closure in large total body surface area injuries. Additionally, this limitation often leads to increased risk of infection, hypertrophic scarring, and extended hospital length of stay. Autologous skin cell suspension (ASCS) prepared using the autologous cell harvesting device is an FDA approved point-of-care regenerative medicine technology that significantly reduces donor skin requirements to achieve definitive closure in acute thermal burn injuries across small and large burns. A prospective uncontrolled observational study (IDE 15945—NCT02992249) was conducted in which patients with life-threatening burn injuries were treated with ASCS. In this study, clinical outcomes were evaluated when ASCS was used in combination with wide meshed autografts for burn site treatment. Within the study, a subset of donor sites was also treated with ASCS and the purpose of the current work was to evaluate the clinical outcomes obtained to better understand impact on healing times and effect of re-harvesting in this compromised patient population. Methods ASCS was applied to the donor site after harvesting of split-thickness skin grafts. Clinical outcomes out to one year were evaluated, including the percentage of re-epithelialization, long-term cosmetic outcomes, and adverse events. Results Subjects (n=96) from 22 burn centers received ASCS as part of their donor site treatment regimen (n=528). Mean subject baseline demographics were: 30.2 years of age, 54.0 ± 17.4% TBSA injury, and 89.4 ± 32.9 Baux score with 37% of subjects having a score greater than 100. Percentage of donor sites healed, defined as >95% re-epithelialization, was 37.1% and 82.7% after week 1 and week 2, respectively. Approximately 20% of the donor sites treated with ASCS were re-harvested multiple times following initial healing (up to four times). Of these donor sites 39.3% (n=84), 81.0% (n=79), and 85.7% (n=77) were healed by week 1, week 2, and week 4, respectively. Scar assessments conducted on 427 donor sites after one year showed the majority had matched or mildly mismatched color, pigment, and texture. Safety analyses of adverse events (AEs) following ASCS treatment were unlikely or unrelated to the device. Conclusions This study demonstrates successful use of ASCS to achieve closure of donor site wounds in patients with extensive burn injuries.