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NCT03005106 · ClinicalTrials.gov registry record · Phase 3
StrataGraft® Skin Tissue in the Promotion of Autologous Skin Regeneration of Complex Skin Defects Due to Thermal Burns That Contain Intact Dermal Elements
A Phase 3 study of Burn, Thermal, sponsored by Stratatech, a Mallinckrodt Company.
- Completed
- Registry status
- Phase 3
- Development phase
- 71
- Enrollment target
- 16
- Study locations
NCT03005106: Completed Phase 3 study of Burn, Thermal, sponsored by Stratatech, a Mallinckrodt Company.
NCT03005106 is a Phase 3 study of Burn, Thermal that has completed, run by Stratatech, a Mallinckrodt Company. The registered enrollment target is 71 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (91% lower). The trial reports 16 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03005106, a Phase 3 study of Burn, Thermal, has completed, sponsored by Stratatech, a Mallinckrodt Company.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 71 participants
- Enrollment target
- 16
- Study locations
Study Summary
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.
Primary Outcome
Percent area autografted by Month 3 is the sum of the percent areas at each study session/visit, up to and including Study Session 7/Month 3 (± 14 d).
Conditions Studied
Interventions
- BIOLOGICAL StrataGraft Skin Tissue
- PROCEDURE Autograft
Study Locations (16)
California
- Universtiy of California - Irvine Health Regional Burn Center - Orange
- UC Davis - Sacramento
Florida
- University of Florida Health Shands Burn Center - Gainesville
- Tampa General Hospital - Regional Burn Center - Tampa
Louisiana
- Baton Rouge Medical Center - Baton Rouge
- University Medical Center - New Orleans
Alabama
- University of South Alabama Medical Center - Mobile
Arizona
- Arizona Burn Center at Maricopa Medical Center - Phoenix
District of Columbia
- MedStar Washington Hospital Center - Washington D.C.
Iowa
- University of Iowa - Iowa City
Missouri
- University of Missouri - Columbia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 71 participants |
| Start Date | 2017-05-30 |
| Est. Completion | 2020-03-27 |
| Phase | Phase 3 |
What the finished NCT03005106 record still lists
NCT03005106 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 71 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (91% lower).
The record links to 1 condition, with Burn, Thermal appearing as the primary indexed condition, and to 2 interventions - of which StrataGraft Skin Tissue is the first listed.
NCT03005106 lists 16 locations in 13 states (California, Florida, Louisiana).
Frequently Asked Questions
What is clinical trial NCT03005106 about?
NCT03005106 is a clinical study titled "StrataGraft® Skin Tissue in the Promotion of Autologous Skin Regeneration of Complex Skin Defects Due to Thermal Burns That Contain Intact Dermal Elements". 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...
What is the current status of trial NCT03005106?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 71 participants. The study started on 2017-05-30. Estimated completion is 2020-03-27.
What conditions does trial NCT03005106 study?
This clinical trial studies the following conditions: Burn, Thermal.
What interventions are being tested in trial NCT03005106?
The interventions under investigation include: StrataGraft Skin Tissue (BIOLOGICAL), Autograft (PROCEDURE).
Who is sponsoring clinical trial NCT03005106?
This trial is sponsored by Stratatech, a Mallinckrodt Company, which has 9 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03005106 being conducted?
This trial has 16 study locations across Alabama, Arizona, California, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03005106's enrollment target sits among peer trials
71 1784th of 2000 higher than 216 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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