The Recell autologous cell harvesting device is designed to use the patient’s own skin cells to treat a variety of skin issues, including burns, reconstructive and cosmetic procedures, the Valencia, Calif.-based company said.
In the newly launched trial, investigators will compare use of the Recell device to the standard of care for approximately 90 patients under 18 years of age. Patients in the trial will be randomized to be treated with either the Recell system and Biobrane dressing, the dressing alone or the standard of care, silver impregnated silicone lined dressing.
The trial’s primary endpoint will be days to re-epithelization of burn injuries, while secondary endpoints will include pain, patient satisfaction and scarring, according to a press release.
Last month, Avita Medical said that it won FDA premarket approval for its Recell autologous cell harvesting device, now cleared for use in treating severe thermal burns in patients 18 and older, and that it plans to launch the device in the fourth quarter.