StrataGraft® Skin Tissue in the Promotion of Autologous Skin Regeneration of Complex Skin Defects Due to Thermal Burns That Contain Intact Dermal Elements
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.
Timeline
- Start
- 2017-05-30
- Primary completion
- 2019-07-31
- Completion
- 2020-03-27
Outcome
Met primary endpoint
registry MEAN All Participants: StrataGraft (Treatment) Sites: 4.33 (Standard Deviation 21.58) percentage of treatment sites NCT03005106 ↗
registry analysis (other test); All Participants; p <0.0001; Mean Difference (Final Values) 97.77 NCT03005106 ↗
paper CONCLUSIONS: Both coprimary endpoints were achieved. PMID 34099322 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | StrataGraft | Other / unclassified | — | — |
Indications
No indication recorded.