Ann: Randomized Controlled Clinical Study of RECELL System, page-7

Is it a study or trial?

'Valencia, Calif., USA, and Melbourne, Australia, 25 October 2018 — AVITA Medical (ASX: AVH, OTCQX:AVMXY), a global regenerative medicine company, today announced that the commencement of arandomized, controlled clinical study of the RECELL® Autologous Cell Harvesting Device (RECELL® System) inthe treatment of significant superficial partial- and mid-thickness pediatric burns, including scald injuries. Theclinical trial is being conducted by the Queensland University of Technology (QUT) in collaboration with thePegg Leditschke Children’s Burns Centre at Lady Cilento Children’s Hospital in Brisbane, QLD. Treatment ofchildren in the trial has commenced. The pediatric clinical trial is being led Dr Bronwyn Griffin, Child HealthResearch Centre, QUT, and Professor Roy Kimble, Roy M Kimble, Lady Cilento Children’s Hospital ·Department of Paediatric Surgery.The protocol for the clinical trial was presented last week at the Australian & New Zealand Burn AssociationAnnual Scientific Meeting in Brisbane by Dr. Anjana Bairagi, Honorary Research Fellow ( Paediatric Surgery )at the Children’s Burns Centre at Lady Cilento Children’s Hospital. The current standard of care for childrenwith partial-thickness burns is cleaning of the wound followed by a dressing application. Limitations of thestandard of care include delay in healing of the burn injury, scarring, and pain. The clinical trial will includeapproximately 90 patients under 18 years old. Patients will be randomized into one of three groups and willbe treated either with the RECELL System and Biobrane® dressing, the Biobrane dressing alone, or standardcare (silver impregnated silicone lined dressing). The primary endpoint will be days to re-epithelization of theburn injury. Secondary endpoints include pain, patient satisfaction and scarring.'