StrataGraft® Skin Tissue in the Promotion of Autologous Skin Regeneration of Complex Skin Defects Due to Thermal Burns That Contain Intact Dermal Elements
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ClinicalTrials.gov Identifier: NCT03005106 |
Recruitment Status :
Completed
First Posted : December 29, 2016
Last Update Posted : May 1, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Trauma-related Wound Burns Skin Wound | Biological: StrataGraft Skin Tissue Procedure: Autograft | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 71 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Intervention Model Description: | See detailed description |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase III Open-label, Controlled, Randomized, Multicenter Study Evaluating the Efficacy and Safety of StrataGraft Skin Tissue in Promoting Autologous Skin Tissue Regeneration of Complex Skin Defects Due to Thermal Burns That Contain Intact Dermal Elements and for Which Excision and Autografts Are Clinically Indicated |
Actual Study Start Date : | May 30, 2017 |
Actual Primary Completion Date : | July 31, 2019 |
Actual Study Completion Date : | March 27, 2020 |
Arm | Intervention/treatment |
---|---|
Experimental: StrataGraft Skin Tissue |
Biological: 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®). Procedure: 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. |
- The difference in the percent area of the StrataGraft treatment site and control autograft treatment site that is autografted by 3 months [ Time Frame: 3 Months ]
- The proportion of subjects achieving durable wound closure of the StrataGraft treatment site at 3 months without autograft placement [ Time Frame: 3 Months ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
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
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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
Exclusion Criteria
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
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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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03005106
United States, Alabama | |
University of South Alabama Medical Center | |
Mobile, Alabama, United States, 36617 | |
United States, Arizona | |
Arizona Burn Center at Maricopa Medical Center | |
Phoenix, Arizona, United States, 85008 | |
United States, California | |
Universtiy of California - Irvine Health Regional Burn Center | |
Orange, California, United States, 92868 | |
UC Davis | |
Sacramento, California, United States, 95817 | |
United States, District of Columbia | |
MedStar Washington Hospital Center | |
Washington, District of Columbia, United States, 20010 | |
United States, Florida | |
University of Florida Health Shands Burn Center | |
Gainesville, Florida, United States, 32610 | |
Tampa General Hospital - Regional Burn Center | |
Tampa, Florida, United States, 33606 | |
United States, Iowa | |
University of Iowa | |
Iowa City, Iowa, United States, 52242 | |
United States, Louisiana | |
Baton Rouge Medical Center | |
Baton Rouge, Louisiana, United States, 70809 | |
University Medical Center | |
New Orleans, Louisiana, United States, 70112 | |
United States, Missouri | |
University of Missouri | |
Columbia, Missouri, United States, 65212 | |
United States, North Carolina | |
Wake Forest University Baptist Medical Center | |
Winston-Salem, North Carolina, United States, 27157 | |
United States, Pennsylvania | |
University of Pittsburgh Medical Center | |
Pittsburgh, Pennsylvania, United States, 15219 | |
United States, Tennessee | |
Regional Medical Center Firefighters Burn Center | |
Memphis, Tennessee, United States, 38103 | |
United States, Texas | |
U.S. Army Institute of Surgical Research Adult Burn Center | |
Fort Sam Houston, Texas, United States, 78234-6315 | |
United States, Wisconsin | |
University of Wisconsin Hospital | |
Madison, Wisconsin, United States, 53792 |
Study Director: | Study Director | Mallinckrodt |
Responsible Party: | Stratatech, a Mallinckrodt Company |
ClinicalTrials.gov Identifier: | NCT03005106 |
Other Study ID Numbers: |
STRATA2016 |
First Posted: | December 29, 2016 Key Record Dates |
Last Update Posted: | May 1, 2020 |
Last Verified: | April 2020 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Wounds and Injuries Burns |