StrataGraft® Skin Tissue as an Alternative to Autografting Full-thickness Complex Skin Defects
Condition: Trauma-related Wound; Burns; Skin Wound
MeSH terms: Wounds and Injuries
Intervention: StrataGraft Skin Tissue; Autograft
Intervention description: StrataGraft® skin tissue is provided as a suturable rectangular piece of stratified epithelial tissue composed of a living dermal matrix containing dermal fibroblasts overlaid with human epidermal keratinocytes (NIKS®).; The current standard of care procedure for the treatment of severe complex skin defects. The procedure involves the removal of a sheet of healthy skin from an uninjured site on the patient and using it to cover the original wound.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: See detailed description
Masking: None (Open Label)
Enrollment: 3.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Full-thickness; Acute trauma

Summary:

      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.
    

Eligibility criteria:

        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