StrataGraft® Skin Tissue in the Promotion of Autologous Skin Regeneration of Complex Skin Defects Due to Thermal Burns That Contain Intact Dermal Elements

Exclusion Criteria

• •Subject-specific criteria:
• •1. Pregnant women
• •2. Prisoners
• •3. Subjects receiving systemic immunosuppressive therapy
• •4. Subjects with a known history of malignancy
• •5. Preadmission insulin-dependent diabetic subjects
• •6. Subjects with concurrent conditions that in the opinion of the investigator may compromise subject safety or study objectives
• •7. Expected survival of less than three months
• •8. Participation in the treatment group of an interventional study within 90 days prior to enrollment
• •Treatment site-specific criteria:
• •9. Full-thickness burns
• •10. Chronic wounds
• •11. The face, head, neck, hands, feet, buttocks, and area over joints
• •12. Treatment sites immediately adjacent to unexcised eschar
• •13. Clinical or laboratory determination of infection at the anticipated treatment sites