A Prospective, Multicenter, Pilot Trial Of A Novel Homologous Skin Construct On Deep Partial-Thickness And...

Split-thickness skin grafting (STSG) is the standard of care for treating deep burns. They often contract, have unpredictable cosmetic outcomes, lack dermal appendages, and result in painful, conspicuous donor sites. An autologous homologous skin construct (AHSC) has been shown to produce full-thickness skin architecture. This study examined the safety profile, engraftment, and quality of healing of a pilot group of AHSC-treated burn wounds. Following IRB approval and informed consent, patients with deep-partial/full-thickness burns requiring grafting underwent side-by-side treatment with AHSC and STSG. A 2 cm2 fullthickness harvest was processed into AHSC at an FDA-registered facility, returned within 48 hours, and applied to a 4 cm2 area alongside a STSG. AHSC donor site was closed primarily. Wounds were evaluated for healing with digital photography and investigator assessments for 90 days. All adverse events (AEs) were recorded. Eight patients with average 13.3% TBSA [range 2-58%] burn wounds were treated: 5 Caucasian and 3 African American with an average body mass index (BMI) of 26.8. Injury was due to predominantly flame burn, with additional injury from grease, scald, contact, friction and flash. Mean time between injury and AHSC treatment was 11 days [range 5-35 days]. All patients had adequate engraftment and complete epithelialization by the end of the study. Patients required one application of AHSC and no other additional surgical procedures at the application sites. The most common AEs for STSG-treated wounds included hypertrophic scarring and pruritus. One non-infected AHSC harvest site experienced a dehiscence. There were no other AEs related to AHSC treatment. AHSC treatment is feasible in deep partial and fullthickness burn wounds warranting additional investigation.