AVITA Medical will enrol 160 paediatric patients, aged between one and 16 years, and use an adaptive design with an interim analysis for the study
UK-based regenerative medicine provider AVITA Medical has enrolled the first patient into a clinical trial of its RECELL System for the treatment of pediatric scald injuries.
The company is conducting the clinical trial at the Arizona Burn Centre of Valleywise Medical Health Centre in Phoenix, Arizona. Biomedical advanced research and development authority (BARDA) is offering funding for the development of the RECELL System.
Arizona Burn Center director Kevin Foster said: “Second-degree burn injuries among children are often the result of an accident, such as a child grabbing and tipping over a pot of boiling water, causing a scald burn of varying depths across the body.
“We typically dress the injury, then watch it for 10-14 days to determine if the wound requires autografting. We are eager to evaluate the RECELL System as an early treatment option as it may speed up the healing process as well as reduce the frequency with which we turn to conventional autografting for treatment of pediatric scalds.”
AVITA Medical will enrol 160 paediatric patients, aged between one and 16 years
Currently, the standard of care for paediatric patients with second-degree burns include application of dressings and following up the injury over time to determine whether skin grafting is needed.
Skin grafting may lead to scar formation in the area of injury and involves the harvesting of donor skin, resulting in an additional wound to the patient, along with associated pain, delayed healing, risk of infection, need for multiple procedures, discoloration and scarring.
AVITA said that the study is aimed at showing the potential of RECELL System in treating the partial-thickness burn injuries within 72-hours, and increasing the incidence of healing by 10 days, compared to a standard wound dressing.
In addition, the study will investigate the effects of both treatments on time to healing, the incidence of conventional autografting, pain, itching, scarring, health-related quality of life and resource utilisation.
The company is expected to enrol 160 paediatric patients, aged between one and 16 years, and use an adaptive design with an interim analysis for the study.
The primary endpoint of the study is showing that treatment of partial-thickness burn injuries with the RECELL System would increase the incidence of healing at day 10 compared with a standardised wound dressing. A clinician blinded to the treatment allocation will evaluate the healing.
AVITA Medical chief executive officer Mike Perry said: “The immediate treatment of scald injuries in pediatric patients represents a shift in thinking as surgeons currently favor a delayed approach to avoid the additional trauma associated with conventional skin grafting.
“With the commencement of this pivotal trial, we intend to demonstrate that treatment with the RECELL System within the first three days of a pediatric burn improves healing and decreases the need for autografting.”