StrataGraft® Skin Tissue in the Promotion of Autologous Skin Regeneration of Complex Skin Defects Due to Thermal Burns That Contain Intact Dermal Elements
Public ClinicalTrials.gov record NCT03005106. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03005106
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 71 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 29, 2017
- Primary completion
- Jul 30, 2019
- Completion
- Mar 26, 2020
- Last update posted
- Jul 13, 2021
2017 – 2020
United States locations
- U.S. sites
- 16
- U.S. states
- 13
- U.S. cities
- 16
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of South Alabama Medical Center | Mobile | Alabama | 36617 | — |
| Arizona Burn Center at Maricopa Medical Center | Phoenix | Arizona | 85008 | — |
| Universtiy of California - Irvine Health Regional Burn Center | Orange | California | 92868 | — |
| UC Davis | Sacramento | California | 95817 | — |
| MedStar Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | — |
| University of Florida Health Shands Burn Center | Gainesville | Florida | 32610 | — |
| Tampa General Hospital - Regional Burn Center | Tampa | Florida | 33606 | — |
| University of Iowa | Iowa City | Iowa | 52242 | — |
| Baton Rouge Medical Center | Baton Rouge | Louisiana | 70809 | — |
| University Medical Center | New Orleans | Louisiana | 70112 | — |
| University of Missouri | Columbia | Missouri | 65212 | — |
| Wake Forest University Baptist Medical Center | Winston-Salem | North Carolina | 27157 | — |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15219 | — |
| Regional Medical Center Firefighters Burn Center | Memphis | Tennessee | 38103 | — |
| U.S. Army Institute of Surgical Research Adult Burn Center | Fort Sam Houston | Texas | 78234-6315 | — |
| University of Wisconsin Hospital | Madison | Wisconsin | 53792 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03005106, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 13, 2021 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03005106 live on ClinicalTrials.gov.