Holmes JH 4th, Molnar JA, Shupp JW, Hickerson WL, King BT, Foster KN, Cairns BA, Carter JE, et al.
Burns : journal of the International Society for Burn Injuries. Date of publication 2019 Jun 1;volume 45(4):772-782.
1. Burns. 2019 Jun;45(4):772-782. doi: 10.1016/j.burns.2018.11.002. Epub 2018 Dec
19.
Demonstration of the safety and effectiveness of the RECELL® System combined with
split-thickness meshed autografts for the reduction of donor skin to treat
mixed-depth burn injuries.
Holmes JH 4th(1), Molnar JA(1), Shupp JW(2), Hickerson WL(3), King BT(4), Foster
KN(5), Cairns BA(6), Carter JE(7).
Author information:
(1)Wake Forest Baptist Medical Center, Winston-Salem, NC, United States.
(2)MedStar Washington Hospital Center, Washington, DC, United States.
(3)University of Tennessee Health Science Center Firefighters Regional Burn
Center, Memphis, TN, United States.
(4)US Army Institute for Surgical Research, Fort Sam Houston, TX, United States.
(5)Maricopa Health System, Phoenix, AZ, United States.
(6)University of North Carolina, Chapel Hill, NC, United States.
(7)Louisiana State University School of Medicine, New Orleans, LA, United States.
INTRODUCTION: Split-thickness skin grafts (STSG) are the standard of care (SOC)
for burns undergoing autografting but are associated with donor skin site
morbidity and limited by the availability of uninjured skin. The RECELL®
Autologous Cell Harvesting Device (RECELL® System, or RECELL) was developed for
point-of-care preparation and application of a suspension of non-cultured,
disaggregated, autologous skin cells, using 1cm2 of the patient's skin to treat
up to 80cm2 of excised burn.
METHODS: A multi-center, prospective, within-subject controlled, randomized,
clinical trial was conducted with 30 subjects to evaluate RECELL in combination
with a more widely meshed STSG than a pre-defined SOC meshed STSG (RECELL
treatment) for the treatment of mixed-depth burns, including full-thickness.
Treatment areas were randomized to receive standard meshed STSG (Control
treatment) or RECELL treatment, such that each subject had 1 Control and 1 RECELL
treatment area. Effectiveness measures were assessed and included complete wound
closure, donor skin use, subject satisfaction, and scarring outcomes out to one
year following treatment.
RESULTS: At 8 weeks, 85% of the Control-treated wounds were healed compared with
92% of the RECELL-treated wounds, establishing the non-inferiority of RECELL
treatment for wound healing. Control-treated and RECELL-treated wounds were
similar in mean size; however, mean donor skin use was significantly reduced by
32% with the use of RECELL (p<0.001), establishing the superiority of RECELL
treatment for reducing donor skin requirements. Secondary effectiveness and
safety outcomes were similar between the treatments.
CONCLUSIONS: In combination with widely meshed STSG, RECELL is a safe and
effective point-of-care treatment for mixed-depth burns without confluent dermis,
achieving short- and long-term healing comparable to standard STSG, while
significantly decreasing donor skin use.
Copyright © 2018 The Authors. Published by Elsevier Ltd.. All rights reserved.
DOI: 10.1016/j.burns.2018.11.002
PMID: 30578048
