89 Pooled Safety Analysis Evaluating Bioengineered Allogeneic Cellularized Construct in Patients with Deep Partial-thickness Thermal Burns

ABSTRACT: Abstract

Introduction

Autograft (AG) is the standard of care treatment for deep burns but requires creation of a donor site wound prone to pain and scarring. Treatment with a bioengineered allogeneic cellularized construct (BACC) is an alternative approach that can reduce or eliminate the need for autografting. The BACC is a bilayer construct that was recently approved in the US for the treatment of adult deep partial-thickness (DPT) burns. Here, we report the analysis of pooled safety data from two open-label, randomized, controlled trials (STRATA2011 [NCT01437852] and STRATA2016 [NCT03005106]) that evaluated efficacy and safety of BACC versus autografting in patients with DPT burns.

Methods

The trials enrolled 101 patients aged ≥18 years with 3–49% total body surface ar

SUBMITTER: Holmes J 

PROVIDER: S-EPMC8946523 | biostudies-literature | 2022 Mar

REPOSITORIES: biostudies-literature