AVITA Medical initiates new trial in paediatric scald injuries

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Regenerative medicine company AVITA Medical (ASX:AVH) has announced the initiation of a trial for the treatment of paediatric scald injuries with an enrollment of the first patient at the Arizona Burn Center at Valleywise Medical Health Center in Phoenix.

The company said the study seeks to demonstrate that treatment with the RECELL System of partial-thickness burn injuries within 72-hours can safely and effectively increase the incidence of healing at day 10 when compared to a standard wound dressing.

“The immediate treatment of scald injuries in paediatric patients represents a shift in thinking as surgeons currently favour 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,” said Dr Mike Perry, AVITA Medical Chief Executive Officer.

“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.”

It is estimated that 30 per cent of burn patients in the US are aged between 1 and 15 and approximately 45 per cent of the paediatric burn injuries are from scalds.

The standard of care for pediatric patients with second-degree burns, such as scalds, is to apply dressings and assess the injury over time to determine if skin grafting is required.

Yet skin grafting results in scar formation in the area treated and involves the harvesting of substantial amounts of donor skin, resulting in an additional wound to the patient. Significant pain, delayed healing, risk of infection, the need for multiple procedures, discolouration and scarring are all associated with skin graft donor site wounds.

“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,” said Dr Kevin Foster, Director of the Arizona Burn Center at Valleywise Health Medical Center.

“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.”

The trial's primary endpoint is to demonstrate that treatment of partial-thickness burn injuries with the RECELL System increases the incidence of healing at day ten compared with a standardised wound dressing. Additionally, 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 will be investigated.