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

Launched by STRATATECH, A MALLINCKRODT COMPANY · Dec 22, 2016

Keywords

ClinConnect Summary

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Gender

ALL

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