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

A Phase III Open-label, Controlled, Randomized, Multicenter Study Evaluating the Efficacy and Safety of StrataGraft Skin Tissue in Promoting Autologous Skin Tissue Regeneration of Complex Skin Defects Due to Thermal Burns That Contain Intact Dermal Elements and for Which Excision and Autografts Are Clinically Indicated

About 70 participants will be enrolled. They will have complex skin defects because of burns caused by heat.

The burns will:

• be on 3-49% of the participant's total body surface area (TBSA)
• require surgery for skin replacement
• include intact dermal elements

The burns are called deep, partial-thickness thermal burns because the skin was damaged by heat but still has some dermis that was not damaged.

The dermis is the layer of skin under the outer layer (epidermis). It is the thickest layer of the skin that provides strength and flexibility to the skin.

All patients will receive both treatments, but on different areas of their burns. Their wounds will not be compared to other patients. One treatment area on their own body will be compared to the other one.

This will help to find out if StrataGraft is safe and effective for deep partial thickness burns. It will also see if StrataGraft might help healing enough to use it instead of the patient's own healthy skin to repair the damage.

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