StrataGraft® Skin Tissue in the Promotion of Autologous Skin Regeneration of Complex Skin Defects Due to Thermal Burns That Contain Intact Dermal Elements
NCT ID: NCT03005106
Last Updated: 2021-07-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
71 participants
INTERVENTIONAL
2017-05-30
2020-03-27
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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StrataGraft Skin Tissue
StrataGraft Skin Tissue
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®).
Autograft
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.
Interventions
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StrataGraft Skin Tissue
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®).
Autograft
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.
Eligibility Criteria
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Inclusion 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
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
18 Years
ALL
No
Sponsors
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Stratatech, a Mallinckrodt Company
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Team Leader
Role: STUDY_DIRECTOR
Stratatech, a Mallinckrodt Company
Locations
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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
Countries
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References
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Gibson ALF, Holmes JH 4th, Shupp JW, Smith D, Joe V, Carson J, Litt J, Kahn S, Short T, Cancio L, Rizzo J, Carter JE, Foster K, Lokuta MA, Comer AR, Smiell JM, Allen-Hoffmann BL. A phase 3, open-label, controlled, randomized, multicenter trial evaluating the efficacy and safety of StrataGraft(R) construct in patients with deep partial-thickness thermal burns. Burns. 2021 Aug;47(5):1024-1037. doi: 10.1016/j.burns.2021.04.021. Epub 2021 Apr 23.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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STRATA2016
Identifier Type: -
Identifier Source: org_study_id
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