Oral Presentation ANZBA Annual Scientific Meeting 2024

Donor Site Burden Reduction: US Multicenter Randomized Controlled Trials Establishing Effectiveness of Autologous Skin Cell Suspension in Burn Treatment  (21007)

Jeffrey E Carter 1 , Andrew Quick 2
  1. University Medical Center, LSU Health School of Medicine, New Orleans, LA, USA
  2. AVITA Medical, LLC, Valencia, CA, USA

Introduction  
Although autografting is considered standard treatment for severe thermal burns, it is often associated with donor site morbidity. The Autologous Cell Harvesting Device (ACHD) is a point-of-care technology enabling clinicians to prepare autologous skin cell suspension (ASCS) for the treatment of burn wounds at a 1:80 expansion ratio.1 To demonstrate safety and effectiveness, two multicenter randomized controlled trials (RCTs) were conducted in the United States treating deep partial- (DPT) and full-thickness (FT) burns.2,3  

Methods  

Trial 1 evaluated DPT burns treated with 2:1 meshed split-thickness skin graft (mSTSG) or ASCS (within-subject control, N=101). Trial 2 included mixed-depth burn wounds (inclusive of FT) randomized to receive the investigator’s standard autograft or ASCS applied over an autograft more widely meshed than the control by a factor of 1 (i.e., 2:1 vs. 3:1+ASCS, within-subject control, N=30).  

Primary endpoints included incidence of wound closure (Trial 1/2), donor site healing (Trial 1), and donor skin required for definitive closure (Trial 2).  Additional treatment and donor site outcomes were assessed, including pain, scarring, re-epithelialization, and safety. Follow-up occurred over 52 weeks. 

Results   
Collectively, ASCS provided robust wound closure comparable to controls, with significantly reduced donor skin requirements (DPT:97.5%, FT:32%).  Donor site healing was significantly improved, as were pain and aesthetic outcomes.  No differences were noted in the rate or severity of safety events. 

Conclusions   
Data from two RCTs demonstrate the use of ASCS as a valid treatment strategy to significantly reduce burden of donor sites in patients with thermal injuries without compromising healing outcomes. 

  1. AVITA Medical (2024) RECELL® Instructions for Use. Available at: https://avitamedical.com/products-recell/instructions-for-use/.
  2. Holmes IV, J.H. et al. (2018). ‘A Comparative Study of the ReCell® Device and Autologous Spit-Thickness Meshed Skin Graft in the Treatment of Acute Burn Injuries’, Journal of Burn Care and Research, 39(5), pp. 694-702. doi:10.1093/jbcr/iry029.
  3. Holmes IV, J.H., et al. (2019). ‘Demonstration of the safety and effectiveness of the RECELL® System combined with split-thickness meshed autografts for the reduction of donor skin to treat mixed-depth burn injuries’, Burns, 45(4), pp. 772-782. doi:10.1016/j.burns.2018.11.002.