AVITA Medical has announced the initiation of a study into soft tissue reconstruction with the enrolment of the first patient at the Arizona Burn Center (Valleywise Medical Health Center, Phoenix, USA). According to a statement, this study will evaluate the safety and effectiveness of the RECELL System when used as an adjunct to meshed autografts in patients undergoing reconstruction of skin defects not associated with a burn injury.
“The commencement of this pivotal trial is an important milestone for AVITA and a critical step toward making the RECELL System broadly available to help patients heal from traumatic or soft tissue wounds with the use of less donor skin than the standard of care,” said Mike Perry, AVITA Medical chief executive officer.
Skin grafting is the standard of care for full-thickness, soft tissue reconstruction, including post-trauma and post-surgical skin reconstruction. Skin grafting requires the harvesting 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 donor site wounds.
While skin grafting is commonly associated with burn treatment, in 2017 approximately 80% of acute wounds that required skin grafting were non-burn related injuries accounting for more than 200,000 procedures in the USA
“We routinely treat acute non-burn wounds using conventional skin grafting, but that approach results in a donor site wound that adds to the patient’s pain and to the cost of their care,” said Kevin Foster, director of the Arizona Burn Center.
“We are eager to evaluate use of the RECELL System as a way to reduce the amount of donor skin required. In burn care, where RECELL is currently FDA-approved, clinical and health economic benefits have been demonstrated. Relative to burn treatment, autografting for non-burn injuries occurs far more frequently, so this has the potential to be a significant treatment advancement for a large number of patients.”
The prospective multicentre trial of at least 65 patients will compare 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 study’s two primary effectiveness endpoints are:
- Superior donor skin sparing, evaluated by comparing the actual expansion ratios of donor skin used to treat the wounds
- Non-inferior incidence of healing by eight weeks post treatment
Healing will be evaluated by a qualified clinician blinded to the treatment allocation. Additional long-term safety and effectiveness data collected over the course of the 52-week study will include blinded evaluation of scar outcomes and patient treatment preference.
The pivotal studies leading to the RECELL System’s FDA premarket approval for the treatment of acute thermal burns demonstrated that the RECELL System treated burns using 97.5% less donor skin when used alone in second-degree burns, and 32% less donor skin when used with autograft for third-degree burns.
Despite the statistically significant reduction in donor skin required to treat burn patients with the RECELL System, burn wounds treated with the RECELL System achieved healing comparable to the burn wounds treated with standard of care.