Introduction
Limited donor site availability complicates the treatment of severe burn injuries. While cultured autologous skin grafting circumvents this limitation, time for culture can increase the risk of infection and mortality. The Autologous Cell Harvesting Device (ACHD) was developed to facilitate point-of-care preparation of autologous skin cell suspension (ASCS) with an expansion ratio of 1:80 to significantly reduce donor skin requirements for patients with severe burns.1
Methods
An uncontrolled, observational study was conducted under the U.S. FDA compassionate use program (IDE 15945 – NCT02992249). Pediatric and adult patients with life-threatening deep partial- or full-thickness burns were treated with ASCS alone, or in combination with a meshed autograft. Donor sites were also treated. Wound healing evaluation occurred at 1, 2, and 4 weeks, monthly until closure, up to 52 weeks.
Results
Patients (N=100) from 22 U.S. institutions, with a mean age of 29.9 years (range >1-74), were treated for a total of 675 injury sites and 514 donor sites. The mean total body surface area of burns was 54% (range 20-95%), and the mean Baux score was 89.7 (range 21-162), with 42% of patients having ≥1 risk factor for impaired healing. By 4 weeks post-treatment, 75.0% of injury sites and 88.1% of donor sites were healed (≥95% re-epithelialized). By 8 weeks, 93.6% of injury sites and 96.9% of donor sites were healed. No unanticipated device-related adverse events occurred.
Conclusions
ASCS is an important treatment option for achieving definitive closure of extensive, life-threatening burn wounds and associated graft donor sites.