Regenerative medicine specialist AVITA Medical Limited (ASX: AVH) has initiated a pivotal trial for the treatment of pediatric scald injuries with enrolment of the first patient at the Arizona Burn Centre at Valleywise Medical Health Center in Phoenix, Arizona.
AVITA Medical Chief Executive Officer, Dr Mike Perry, said this 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 pediatric patients represents a shift in thinking as surgeons currently favour a delayed approach to avoid the additional trauma associated with conventional skin grafting,” Dr 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 pediatric 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.”
In the US, it is estimated that 30% of burn patients are within the ages of one to 15 years old, and approximately 45% of the pediatric burn injuries are from scald burns.
The standard of care for pediatric patients with second-degree burns, such as scald burns, is to apply dressings and assess the injury over time to determine if skin grafting is required.
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, discoloration 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 Centre.
“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.”
Dr Perry said the primary endpoint of this prospective multi-centre trial is to demonstrate that treatment of partial-thickness burn injuries with the RECELL System increases the incidence of healing at day 10 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 utilization will be investigated. Enrollment of 160 pediatric patients, ages one to 16 years old, is planned. This study utilizes an adaptive design with an interim analysis.
Healing will be evaluated by a clinician blinded to the treatment allocation. Additional data collected over the course of the 52-week study will include blinded evaluation of scar outcomes, evaluation of disease-specific quality of life, and healthcare resource utilisation.