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Clinical Trial Summary

The proposed study is designed as a phase II open-label, controlled, randomized, multicenter, dose-escalation study of the safety, tolerability, and efficacy of a single or multiple applications of StrataGraft skin tissue as an alternative to autografting in promoting the healing of excised full-thickness complex skin defects resulting from acute traumatic skin loss. The proposed study population will include patients with up to 49% Total Body Surface Area (TBSA) complex skin defects including a full-thickness component. The study has been designed to focus on the evaluation of safety and tolerability of prolonged exposure to increasing amounts of a single or multiple applications of StrataGraft skin tissue, while also assessing the potential for StrataGraft tissue to promote healing of the full-thickness component of these complex skin defects as an alternative to donor site harvesting and autografting. Targeted enrollment for this study is up to 20 subjects with complex skin defects due to acute traumatic skin loss which require surgical excision and autografting. Subjects will be sequentially enrolled in two cohorts of increasing treatment area receiving StrataGraft skin tissue.

Clinical Trial Description

After surgical excision of nonviable tissue, two comparable areas of comparable depth on each subject will be identified and the areas will be randomized to receive StrataGraft skin tissue or a surgically harvested autograft as the intrapatient comparator. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT03005054
Study type Interventional
Source Mallinckrodt
Status Terminated
Phase Phase 2
Start date April 24, 2017
Completion date October 31, 2019

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