Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Avita Medical
With
United States Department of Defense
Royal Perth Hospital
MedDRA Assistance Inc
BioStat International, Inc.
Age
18–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
The subject requires primary skin grafting as a result of an acute thermal burn injury
The area of the burn injury is at least 200cm2 (1% TBSA in adults) if a contiguous wound, or at least 100cm2 for each of 2 noon-contiguous wounds
The area of total burn injury is 1-20% TBSA
The burn injured area can be divided into two treatment areas ( control and treatment) with 100-320cm2 area for each treatment type
The study treatment area is a second degree burn injury
The subject is between 18-65 years of age
The subject is willing to complete all follow-up evaluations required by the study protocol
The subject is to abstain from any other treatment of the wound(s) for the duration of the study unless medically necessary
The subject agrees to abstain from enrollment in any other clinical trial for the duration of the study
The subject and/or guardian are able to read and understand instructions and give informed, voluntary, written consent
The subject is able and willing to follow the protocol requirements
You may not be if
The subject's burn injuries were caused by chemicals, electricity, and/or radioactive substances
The total subject burn injury is less than 1% or more than 20% TBSA
The subject has a microbiologically proven pre-existing local or systemic bacterial infection
The subject has been receiving a systemic antibiotic for more than 48 hours prior to grafting
The subject is known to have a pre-existing condition that may interfere with wound healing ( e.g. malignancy, diabetes, or autoimmune disease)
The subject is unable to follow the protocol
The subject is taking medication known to have an effect on wound healing or skin pigmentation ( e.g. systemic corticosteroids, retinoids, etc)
The subject has other concurrent conditions that in the opinion of the investigator may compromise patient safety or study objectives
The subject has a known hypersensitivity to Trypsin or Compound sodium Lactate for Irrigation (Hartmann's) solution
Clareo Health | A Multicenter Comparative Study of the ReCell Device and Autologous Split-thickness Meshed Skin Graft in the Treatment of Acute Burn Injuries
