StrataGraft® Skin Tissue as an Alternative to Autografting Full-thickness Complex Skin Defects

Exclusion Criteria

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