Regenerative medicine company Avita Medical (ASX: AVH) has commenced what it calls a “pivotal trial” for the treatment of paediatric scald injuries, seeking to demonstrate that its RECELL treatment can safely and effectively increase the incidence of healing when compared to a standard wound dressing.
The new study is Avita’s second in as many days after the company announced a trial into RECELL and its ability to conduct soft tissue reconstruction earlier this week.
In today’s announcement, Avita said the Arizona Burn Center at Valleywise Medical Health Center in Phoenix had enrolled its first patient with the primary endpoint of the trial being to demonstrate that the RECELL system can improve healing after 10 days.
Additionally, the effects of both treatments on time of healing, the incidence of conventional autografting, pain, itching, scarring, health-related quality of life and resource utilisation will also be investigated as part of the research.
Avita has said its scald injury study will include about 160 paediatric patients, aged between one and 16 years old with healing to 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.
Meanwhile, the soft tissue reconstruction trial will include at least 65 patients, comparing the clinical performance of conventional skin grafting to the use of the RECELL system in combination with more widely meshed autografts on acute full-thickness non-burn skin defects.
“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,” said Dr Mike Perry, chief executive officer of Avita.
Avita’s RECELL system is a device that produces a suspension of what the company calls “Spray-On Skin Cells” using a small sample of the patient’s own skin. This suspension contains the cells necessary to regenerate the outer layer of natural, healthy skin and is prepared and applied at the point-of-care in 30 minutes.
Speaking about the potential outcome of the trial, Dr Perry said that Avita intends to demonstrate the efficacy of the RECELL system and its capabilities within the first three days of a paediatric burn.
Most importantly, Avita wants to prove that the system improves healing and decreases the need for autografting – often a counterproductive procedure that leads to scarring and further complications for burns patients.
According to official statistics from the US, around 30% of all burn patients are under the age of 15, with 45% of paediatric burn injuries derived from scald burns.
Burns are caused by dry heat such as by an iron or fire, while scalds are caused by something wet, such as hot water or steam.
The standard of care for paediatric 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.
According to Avita, significant pain, delayed healing, risk of infection, the need for multiple procedures, discolouration and scarring are all associated with skin graft donor site wounds.
“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 paediatric scalds,” said Dr Kevin Foster, director of the Arizona Burn Center at Valleywise Health Medical Center.