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StrataGraft® Skin Tissue as an Alternative to Autografting Full-thickness Complex Skin Defects

Burns Clinical Trial

Official title:
Open-label, Controlled, Randomized, Multicenter, Dose Escalation Study Evaluating the Safety, Tolerability, and Efficacy of Single or Multiple Applications of StrataGraft® Skin Tissue as an Alternative to Autografting Full-thickness Complex Skin Defects

Clinical Trial Summary

About 20 participants will be enrolled in this trial if they have had an accident that damages both the dermal (outside) and epidermal (inside) layers of skin on up to 49% of their body. This condition is called full-thickness complex skin defects resulting from acute traumatic skin loss. Participants will be treated with StrataGraft skin tissue to evaluate it's safety and effectiveness for use in treating full-thickness complex skin defects.

Clinical Trial Description

The objective of this range-finding study was to assess the safety, tolerability, and efficacy of single or repeated application of StrataGraft skin tissue in full-thickness complex skin defects resulting from acute traumatic skin loss (eg, thermal burns or degloving injuries) requiring surgical excision and autografting. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03005054
Study type Interventional
Source Mallinckrodt
Contact
Status Terminated
Phase Phase 2
Start date April 24, 2017
Completion date March 26, 2019
View Details
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