Safety and efficacy of bio-engineered, autologous dermo-epidermal skin grafts in reconstructive surgery: 1-year results of a prospective, randomized, intra-patient controlled, multicenter phase II clinical trial

Extensive full-thickness defects remain challenging to reconstruct, as various techniques used, such as split-thickness skin grafts, often result in donor site morbidity and functional and cosmetic scar sequelae. This study evaluated the safety and efficacy of denovoSkin™-a bio-engineered autologous dermo-epidermal skin graft consisting of patient-derived epidermal and dermal cells cultured within an extracellular matrix-compared to autologous split thickness skin grafts (STSG). Twenty-three patients (mean age 37.4 years; 65% male; 70% post-burn scars), received both denovoSkin™ and STSG on comparable wound areas. At 3 months, scar quality was significantly better for denovoSkin™ than for STSG (POSAS observer total score 23.4 vs 27.9; <i>p</i> = 0.008), with benefits maintained at 12 months. Elasticity parameters also consistently favored denovoSkin™, and the ratio of covered surface area to donor site was markedly higher (8.5 vs 0.9; <i>p</i> < 0.001). DenovoSkin™ is a safe and effective treatment for full-thickness skin defects, providing favorable long-term skin quality. <b>Clinical Trial Registration:</b> Clinicaltrials.gov NCT03394612.