StrataGraft® Skin Tissue Expanded Access at Specific Study Sites ( StrataCAT )
Public ClinicalTrials.gov record NCT04123548. 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 Multicenter, Open-label, Study of StrataGraft® Skin Tissue in Adult Subjects With Deep Partial-Thickness Thermal Burns
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
An autograft is a piece of skin taken from a healthy area of the body to be used to treat severe burns on another part of the same body. StrataGraft skin tissue was an investigational tissue that could be used as an alternative to an autograft. * StrataGraft skin tissue was in late-stage clinical development for the treatment of adults with deep partial-thickness (DPT) burns. * There were no safety concerns reported to date. The sponsor submitted a treatment protocol to Food and Drug Administration (FDA) for doctors who participated in the Phase 3 Strata 2016 study (NCT 03005106) to allow for expanded access to StrataGraft before it was commercially available. The main purpose of the study was to allow patients to receive StrataGraft during Biologics License Application review and prior to approval by the FDA for the treatment of DPT burns. The primary outcome measure was the number of participants with adverse events and safety concerns.
Study identification
- NCT ID
- NCT04123548
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 52 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
- Feb 18, 2020 (Actual)
- Primary completion
- Jan 26, 2022 (Actual)
- Completion
- Jan 26, 2022 (Actual)
- Last update posted
- Nov 9, 2023
2020 – 2022
United States locations
- U.S. sites
- 10
- U.S. states
- 9
- U.S. cities
- 10
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of California Irvine | Orange | California | 92868-3298 | — |
| MedStar Health Research Institute | Washington D.C. | District of Columbia | 20010 | — |
| University of Florida (Health Shands Burn Center) | Gainesville | Florida | 32610 | — |
| University of Iowa | Iowa City | Iowa | 52242 | — |
| Baton Rouge General | Baton Rouge | Louisiana | 70809 | — |
| University Medical Center New Orleans | New Orleans | Louisiana | 70113 | — |
| University of Missouri | Columbia | Missouri | 33136 | — |
| Wake Forest University | Winston-Salem | North Carolina | 27157 | — |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15219 | — |
| 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 NCT04123548, 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 Nov 9, 2023 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04123548 live on ClinicalTrials.gov.