StrataGraft Safety, Tolerability and Efficacy in Pediatric Subjects

Exclusion Criteria

• •Is pregnant or breastfeeding
• •Receiving treatment to suppress the immune system and/or systemic corticosteroids (inhaled corticosteroids are permitted)
• •A known history of malignancy
• •Pre-admission insulin-dependent diabetes
• •Concurrent trauma, conditions, and/or personal situations that, in the opinion of the investigator, may compromise the participant's safety or the study objectives
• •A burn injury that occurred ≥ 14 days prior to planned StrataGraft application Is expected to survive less than 12 months
• •Is participating in another interventional trial, or did within 90 days before enrollment
• •A proposed study treatment site that has been previously excised or autografted; located adjacent to an undebrided/unexcised burn area; demonstrates signs and symptoms of wound infection, per judgement of the clinical investigator; lies across joints or is located on the feet (i.e., distal to the malleolus), hands (distal to the wrist), face, neck, buttocks, perineum, or genitalia