Using an Autologous Skin Cell Suspension Combined with a More Wide Meshed Autograft Reduces Donor Skin Requirements for Reconstruction of Full-thickness Skin Defects

Introduction: Donor site wounds created for autografting are associated with significant morbidity. The Autologous Cell Harvesting Device is used by a clinician at the point of care to prepare an autologous skin cell suspension (ASCS) with a donor-to-treatment site area ratio of 1:80. This study evaluates the safety and effectiveness of the use of ASCS for reconstructing nonthermal full-thickness skin defects (FTSDs).Methods:This was a multicenter, randomized, within-subject controlled study with blinded evaluators. Patients eligible for enrollment had acute, nonthermal FTSDs requiring autografting. Grafting strategies to achieve closure were devised to align with the investigators’ standard of care. Two comparably sized treatment areas on each patient were randomized to receive either the investigator’s pre-identified standard of care autograft (Control), or ASCS used in combination with an autograft more widely meshed than Control by a factor of 1. Non-inferiority of wound healing (100% healing by 8 weeks post-treatment) and superiority of donor skin reduction (donor-to-treatment site ratio comparison) for ASCS-treated wounds were evaluated as primary effectiveness endpoints.Results:Sixty-five patients across 18 centers were enrolled in this study, with FTSDs of both surgical (63%) and traumatic (37%) origin. ASCS treatment in combination with a more widely meshed autograft met both primary effectiveness endpoints, achieving non-inferior wound healing (p=0.005) and superior donor skin reduction (p