Safety and Efficacy Study of Autologous Engineered Skin Substitute to Treat Partial- and Full-Thickness Burn Wounds

Inclusion Criteria: * Has deep partial or full-thickness thermal burns ≥50% of the TBSA and fulfills the total grafting area requirement ranging from 288 cm2 up to 5,600 cm2, divided between two (or more) recipient sites. * Is expected to require multiple skin grafting procedures. * Is ≥18 years and ≤40 years of age at the time of enrollment. * Females of childbearing potential must have a negative pregnancy test prior to enrollment and agree to use appropriate birth control methods during the pre-grafting period and for three months following the last Grafting Day. * Subject (or a legally authorized representative (LAR)) has provided written informed consent for study participation and procedures to be performed. Exclusion Criteria: * Has a current diagnosis of septic shock or Multiple Organ Dysfunction Syndrome, which in the opinion of the Investigator would put the potential subject at risk of serious morbidity or death by participating in the study. * Has a current diagnosis of an invasive burn wound infection in unexcised burn wound. * Is pregnant. * Is a prisoner at the time of obtaining written informed consent. * Has a documented history of allergy or sensitivity to any of the antimicrobials or reagents used in preparation and application of ESS-W including the irrigation solution used before and after grafting. These include aminoglycosides, polymyxin B, mupirocin, ciprofloxacin, amphotericin B, hydrocortisone, and insulin. * Has a documented history of allergy or…