96 Treatment of Donor Sites in Large TBSA Burn Injuries with an Autologous Skin Cell Suspension Supports Early Reharvesting

Abstract

Abstract Introduction Treatment of large TBSA burn injuries is often limited by donor site availability and requires reharvesting to obtain definitive closure. Patients with severe injuries may have delayed closure compared to uncompromised patients that typically have their donor sites healed in 7–14 days. Autologous skin cell suspension (ASCS) can be prepared to treat burn wounds at the point-of-care. The safety and effectiveness have not yet been established for use in the treatment of donor sites. This study presents the use of ASCS for the treatment of donor sites in patients with life-threatening burn injuries that were enrolled in a prospective uncontrolled observational study (IDE 15945—NCT02992249). Methods ASCS was applied to the donor site after harvesting of STSGs. Clinical outcomes out to one year were evaluated including percentage of re-epithelialization, long-term cosmetic outcomes, and adverse events. Results Ninety-six subjects from 22 burn centers had their donor sites treated with ASCS as part of their treatment regimen. The average subject age was 30.1 and the average TBSA injury was 53.7 ±17.3%. The mean Baux score was 89.2 with 36% of subjects having a score greater than 100. Collectively, 528 donor sites were individually treated. In this compromised patient population 37.5% were ≥95% re-epithelialized by week 1 (n=435), and by week 2, 82.7% of the donor sites were ≥95% re-epithelialized (n=434), regardless of how many times they were harvested. Approximately 19% of the donor sites treated with ACSC were reharvested multiple times following initial healing (15% two times, 2.3% three times, and 7 donor sites were harvested 4 times) and retreated. Of donor sites harvested more than once, 39.3% (n=84), 81% (n=79), and 85.7% (n=77) of sites were ≥ 95% re-epithelialized by week 1, 2 and 4, respectively. One-year data was available for 427 donor sites and the majority had matched or mildly mismatched color, pigment, and texture. Adverse events included one site with a hematoma, one patient with donor sites that had fragile skin loss secondary to traumatic friction, one patient with active bleeding, two patients with anemia secondary to donor site bleeding, one patient with delayed closure due to mild infection of staph species. All AEs were unlikely or unrelated to the device. Conclusions ASCS has been successfully used to achieve closure of donor site wounds without significant safety risk in patients with extensive burn injuries. Applicability of Research to Practice Application of ASCS for donor site healing may be particularly relevant for patients with large burn injuries requiring subsequent reharvesting to achieve definitive closure.