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

Completed · Phase 3

Conditions studied: Burn, Thermal

In brief

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.

Key facts

Study ID

NCT03005106

Run by

Stratatech, a Mallinckrodt Company

People needed

71

Starts

2017-05-30

Expected to finish

2020-03-27

Last updated by the study team

2021-07-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject-specific criteria:
• Men and women aged ≥ 18 years
• Written informed consent
• Sufficient healthy skin identified and reserved as a donor site in the event that the StrataGraft treatment site requires autografting
• Clinical expectation that the study donor site will heal without grafting
• Complex skin defects of 3-49% TBSA
• Total burn may consist of more than one area
• Treatment site-specific criteria:
• Thermal burn(s) with intact dermal elements for which excision and autografting are clinically indicated
• Total of both study treatment areas can be up to 2000 cm2
• First excision and grafting of study treatment sites
• Thermal burn(s) on the torso, arms, or legs

You may not qualify if…

• Subject-specific criteria:
• Pregnant women
• Prisoners
• Subjects receiving systemic immunosuppressive therapy
• Subjects with a known history of malignancy
• Preadmission insulin-dependent diabetic subjects
• Subjects with concurrent conditions that in the opinion of the investigator may compromise subject safety or study objectives
• Expected survival of less than three months
• Participation in the treatment group of an interventional study within 90 days prior to enrollment
• Treatment site-specific criteria:
• Full-thickness burns
• Chronic wounds
• The face, head, neck, hands, feet, buttocks, and area over joints
• Treatment sites immediately adjacent to unexcised eschar
• Clinical or laboratory determination of infection at the anticipated treatment sites

Where it is running

• University of South Alabama Medical Center — Mobile, Alabama, United States
• Arizona Burn Center at Maricopa Medical Center — Phoenix, Arizona, United States
• Universtiy of California - Irvine Health Regional Burn Center — Orange, California, United States
• UC Davis — Sacramento, California, United States
• MedStar Washington Hospital Center — Washington D.C., District of Columbia, United States
• University of Florida Health Shands Burn Center — Gainesville, Florida, United States
• Tampa General Hospital - Regional Burn Center — Tampa, Florida, United States
• University of Iowa — Iowa City, Iowa, United States
• Baton Rouge Medical Center — Baton Rouge, Louisiana, United States
• University Medical Center — New Orleans, Louisiana, United States
• University of Missouri — Columbia, Missouri, United States
• Wake Forest University Baptist Medical Center — Winston-Salem, North Carolina, United States
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
• Regional Medical Center Firefighters Burn Center — Memphis, Tennessee, United States
• U.S. Army Institute of Surgical Research Adult Burn Center — Fort Sam Houston, Texas, United States
• University of Wisconsin Hospital — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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