UK-based regenerative medicine company AVITA Medical has enrolled the first patient for its pivotal study to evaluate the RECELL system for the treatment of paediatric scald injuries.
The study aims to establish that treatment of partial-thickness burn injuries using the RECELL system, within 72-hours, can effectively aggregate the chances of healing at day ten, compared with a standard wound dressing.
The patient for the prospective multi-centre trial enrolled at the Arizona Burn Center at Valleywise Medical Health Center in Phoenix, Arizona, US.
AVITA Medical CEO Dr Mike Perry said: “With the commencement of this pivotal trial, we intend to demonstrate that treatment with the RECELL System within the first three days of a paediatric burn improves healing and decreases the need for autografting.
“Building on the success surgeons have had in treating burns in adult patients, we look forward to potentially expanding the use of the RECELL System to benefit pediatric patients with burns and are pleased to progress toward this with the commencement of this pivotal trial.”
AVITA Medical’s trial aims to evaluate the effects of both treatments on time to healing, the incidence of conventional autografting, itching, pain, scarring, as well as health-related quality of life and resource.
The trial will enrol 160 paediatric patients between the ages of one and 16 years. It uses an adaptive design with an interim analysis.
The standard of care provided for pediatric patients with scald burns includes dressing and examining the injury over time to decide if skin grafting is required, whereas the RECELL system expedites the healing.
In the US, an estimated 30% of burn patients are within the ages of one to 15 years old.