NCT03005106

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 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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 71 (actual)
• Sponsor: Stratatech, a Mallinckrodt Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Burn, Thermal

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-05-30
• Primary completion: 2019-07-31
• Completion: 2020-03-27
• First posted: 2016-12-29
• Last updated: 2021-07-14
• Results posted: 2021-07-12

Locations

16 sites across 1 country: United States

Regulatory

• FDA-regulated drug study