10
Participants
Start Date
September 30, 2016
Primary Completion Date
December 31, 2019
Study Completion Date
July 31, 2020
Autologous Engineered Skin Substitute
"The total burn wound area covered will range from 288 cm\^2 to 5,600 cm\^2 (based on availability of matched-pair burn sites of similar area and depth) and this total grafting area will be divided equally for treatment with ESS-W and AG.~ESS-W will be applied to the appropriate recipient site, according to the randomization schedule, by the surgeon using two pairs of forceps. Sufficient ESS-W sheets will be used to cover the recipient site. The ESS-W grafts will be stapled in place."
Split-Thickness Autograft (AG)
"The total burn wound area covered will range from 288 cm\^2 to 5,600 cm\^2 (based on availability of matched-pair burn sites of similar area and depth) and this total grafting area will be divided equally for treatment with ESS-W and AG.~The AG regimen occurs in stages, beginning with excision of the burned skin, followed by temporary wound coverage (e.g. cadaveric skin allografts, porcine xenograft, synthetic or biologic dressings or medical devices) to achieve wound homeostasis, and completed by permanent wound closure using autologous skin."
US Army Institute of Surgical Research, Houston
Arizona Burn Center, Pheonix
Harborview Medical Center, Seattle
Collaborators (1)
Amarex Clinical Research
OTHER
Amarantus BioScience Holdings, Inc.
INDUSTRY