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

Inclusion Criteria

Subject-specific criteria:

1. Men and women aged ≥ 18 years

2. Written informed consent

3. Sufficient healthy skin identified and reserved as a donor site in the event that the
StrataGraft treatment site requires autografting

4. Clinical expectation that the study donor site will heal without grafting

5. Complex skin defects of 3-49% TBSA

- Total burn may consist of more than one area

Treatment site-specific criteria:

6. Thermal burn(s) with intact dermal elements for which excision and autografting are
clinically indicated

7. Total of both study treatment areas can be up to 2000 cm2

8. First excision and grafting of study treatment sites

9. Thermal burn(s) on the torso, arms, or legs

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