Safety and Efficacy Study of Autologous Engineered Skin Substitute to Treat Partial- and Full-Thickness Burn Wounds

PHASE2UnknownINTERVENTIONAL
Enrollment

10

Participants

Timeline

Start Date

September 30, 2016

Primary Completion Date

December 31, 2019

Study Completion Date

July 31, 2020

Conditions
Thermal InjuryDeep Partial-Thickness BurnFull-Thickness Burn
Interventions
DRUG

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."

DRUG

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."

Trial Locations (3)

78234

US Army Institute of Surgical Research, Houston

85008

Arizona Burn Center, Pheonix

98104

Harborview Medical Center, Seattle

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Amarex Clinical Research

OTHER

lead

Amarantus BioScience Holdings, Inc.

INDUSTRY

NCT01655407 - Safety and Efficacy Study of Autologous Engineered Skin Substitute to Treat Partial- and Full-Thickness Burn Wounds | Biotech Hunter | Biotech Hunter