StrataGraft® Skin Tissue in the Promotion of Autologous Skin Regeneration of Complex Skin Defects Due to Thermal Burns That Contain Intact Dermal Elements
Condition: Burn, Thermal
MeSH terms: Burns
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 burns. 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 burn wound.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: See detailed description
Masking: None (Open Label)
Enrollment: 71.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Trauma-related wound; Deep partial thickness; Skin wound

Summary:

      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.
    

Eligibility criteria:

        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