CONTINUED ACCESS PROTOCOL: Demonstration of the Safety and Effectiveness of ReCell® Combined With Meshed Skin Graft for Reduction of Donor Area in the Treatment of Acute Burn Injuries

NACompletedINTERVENTIONAL
Enrollment

12

Participants

Timeline

Start Date

October 31, 2016

Primary Completion Date

December 31, 2017

Study Completion Date

September 30, 2018

Conditions
Burns
Interventions
DEVICE

ReCell

"The ReCell-assigned treatment area will be treated as described in the product's Instructions for Use. In summary, 1ml of fluid physically covers a treatment area of 80 cm2. Each milliliter of fluid contains cells harvested from a square centimeter of thin split-thickness skin sample.~The reagents and components of the ReCell kit are used, in a scalable fashion, to facilitate disaggregation of cells from skin samples into filtered cell suspension. Areas to be harvested for skin samples are to be clean and show no evidence of surrounding cellulitis or infection. Treatment area sizes and cell suspension volumes are to be recorded."

Trial Locations (6)

20010

MedStar Washington Hospital Center, Washington D.C.

27157

Wake Forest Baptist Medical Center, Winston-Salem

33606

Tampa General Hospital, Tampa

85008

Arizona Burn Center at Maricopa Integrated Health Systems, Phoenix

38103-3409

University of Tennessee Health Science Center, Memphis

78234-7767

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

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Avita Medical

INDUSTRY