StrataGraft® Skin Tissue in the Promotion of Autologous Skin Regeneration of Complex Skin Defects Due to Thermal Burns That Contain Intact Dermal Elements

PHASE3CompletedINTERVENTIONAL
Enrollment

71

Participants

Timeline

Start Date

May 30, 2017

Primary Completion Date

July 31, 2019

Study Completion Date

March 27, 2020

Conditions
Burn, Thermal
Interventions
BIOLOGICAL

StrataGraft Skin Tissue

StrataGraft® skin tissue is provided as a suturable rectangular piece of stratified epithelial tissue composed of a living dermal matrix containing dermal fibroblasts overlaid with human epidermal keratinocytes (NIKS®).

PROCEDURE

Autograft

The current standard of care procedure for the treatment of severe burns. The procedure involves the removal of a sheet of healthy skin from an uninjured site on the patient and using it to cover the original burn wound.

Trial Locations (16)

15219

University of Pittsburgh Medical Center, Pittsburgh

20010

MedStar Washington Hospital Center, Washington D.C.

27157

Wake Forest University Baptist Medical Center, Winston-Salem

32610

University of Florida Health Shands Burn Center, Gainesville

33606

Tampa General Hospital - Regional Burn Center, Tampa

36617

University of South Alabama Medical Center, Mobile

38103

Regional Medical Center Firefighters Burn Center, Memphis

52242

University of Iowa, Iowa City

53792

University of Wisconsin Hospital, Madison

65212

University of Missouri, Columbia

70112

University Medical Center, New Orleans

70809

Baton Rouge Medical Center, Baton Rouge

85008

Arizona Burn Center at Maricopa Medical Center, Phoenix

92868

Universtiy of California - Irvine Health Regional Burn Center, Orange

95817

UC Davis, Sacramento

78234-6315

U.S. Army Institute of Surgical Research Adult Burn Center, Fort Sam Houston

All Listed Sponsors
lead

Stratatech, a Mallinckrodt Company

INDUSTRY

NCT03005106 - StrataGraft® Skin Tissue in the Promotion of Autologous Skin Regeneration of Complex Skin Defects Due to Thermal Burns That Contain Intact Dermal Elements | Biotech Hunter | Biotech Hunter