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

This study is designed to evaluate the safety and efficacy of autologous engineered skin
substitute (ESS-W) compared to conventional split-thickness AG for the treatment of
extensive, deep partial- and full-thickness thermal burns. A matched and randomized burn
site format will be used to evaluate the successful graft take on excised deep partial- and
full-thickness burns when grafted with either 1) unmeshed ESS-W or 2) meshed AG (the current
standard treatment of split thickness AG).

This research study is divided into five study periods: (1) Screening Period of up to one
week and (2) Pre-Grafting Period, which will last approximately 35-45 days, (3) Grafting
Day(s), which are the day(s) on which grafts are applied (i.e., First Graft: Day 0 and the
optional subsequent Grafting Day i.e., Second Graft: Day 0), (4) Post Grafting Observation
Period, which begins with 28 days follow-up after each Grafting Day(s), and continues till
Post-Operative Month (POM) 6 from the last Grafting Day, and (5) Anecdotal Observation
Period

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 sensitivity to any of the animal products used
in preparation of ESS-W. These products include bovine blood, bovine collagen, bovine
collagenase, and porcine trypsin-versene.

- Has a documented history of allergy or sensitivity to glycosaminoglycan, the polymer
component of ESS-W.

- Has a documented ongoing condition which could delay wound healing such as
insulin-dependent diabetes mellitus, Cushing syndrome or disease, scurvy, chronic
hypothyroidism, congenital or acquired immunosuppressive condition, chronic renal
failure, or chronic hepatic dysfunction (Child-Pugh class B or C).

- Has a severe malnutrition or other concomitant illness which, in the opinion of the
Investigator, has the potential to significantly delay wound healing.