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

Open-label, Controlled, Randomized, Multicenter, Dose Escalation Study Evaluating the Safety, Tolerability, and Efficacy of Single or Multiple Applications of StrataGraft® Skin Tissue as an Alternative to Autografting Full-thickness Complex Skin Defects

About 20 participants will be enrolled in this trial if they have had an accident that damages both the dermal (outside) and epidermal (inside) layers of skin on up to 49% of their body.

This condition is called full-thickness complex skin defects resulting from acute traumatic skin loss.

Participants will be treated with StrataGraft skin tissue to evaluate it's safety and effectiveness for use in treating full-thickness complex skin defects.

The objective of this range-finding study was to assess the safety, tolerability, and efficacy of single or repeated application of StrataGraft skin tissue in full-thickness complex skin defects resulting from acute traumatic skin loss (eg, thermal burns or degloving injuries) requiring surgical excision and autografting.

Inclusion Criteria:

1. Men and women aged 18-65 years, inclusive

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. Complex skin defects of up to 49% Total Body Surface Area (TBSA) requiring excision and autografting

   • Total skin defect may consist of more than one wound area

5. Full-thickness complex skin defects requiring excision and autografting

6. Study treatment sites on the torso and limbs may be up to 200 cm2 in cohort 1 and 400 cm2 in cohort 2

7. For thermal burns only, first excision and grafting of treatment sites

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