Spray On Skin
“The US Food and Drug Administration (FDA) has approved a premarket approval application for spray-on skin cell device for adult patients with severe thermal burns.
The RECELL Autologous Cell Harvesting Device, from global regenerative medicine company AVITA Medical, has been approved for burn patients aged 18 years and older. As a direct-care system evidenced to treat burns in as little as 30 minutes, the RECELL system vies to limit the rate of required donor skin in severe thermal burn treatments.
The device, which uses a small amount of the patient’s own skin to prepare for the spray-on therapy, was approved on the strength of a pair of randomized, controlled clinical trials demonstrating the treatment of acute burn wounds. In the first trial, RECELL System was compared versus conventional split-thickness autografts in patients with deep second-degree burn injuries. Patients treated with the RECELL Systems were required to donate 97.5% less skin than standard-of-care, and reported statistically significant reduction in patient-reported pain, increases in satisfaction, and improved outcomes in donor scars. Though the patients needed to donate substantially less skin to treatment with the RECELL System, their burn sites achieved comparable definitive closure to standard-of-care.
FDA approval was based on the results of two randomized, controlled clinical trials comparing the treatment of burn patients with the RECELL System against the standard of care. The first controlled trial compared treatment with the RECELL System versus treatment with conventional split-thickness autografts in patients with deep partial-thickness (second-degree) burn injuries.
During the pivotal trial, the patient donor skin required to be harvested to treat burn sites with the RECELL System was 97.5% less than the amount harvested to treat burn sites using standard of care resulting in a statistically significant reduction in patient-reported pain, increased patient satisfaction and improved donor scar outcomes. Despite the statistically significant reduction in donor skin required to treat with the RECELL System, burn sites treated with RECELL achieved definitive closure comparable to the burn sites treated with standard of care. “