Compassionate use of ReCell in large burns: A single-center U.S. experience

James H. Holmes IV, MD1, Joseph A. Molnar, MD, PhD2, Jeffrey W. Williams, PA-C2, Christopher K. Craig, PA-C2, Jeffrey E. Carter, MD2

1 WFBMC Burn Center, Medical Center Blvd, Winston-Salem, NC, USA 27157, jholmes@wakehealth.edu
2 WFBMC Burn Center, Medical Center Blvd, Winston-Salem, NC, USA 27157

Introduction

Split-thickness autografts (STAG) are the standard of care for the permanent coverage of full-thickness burns. To assist in closing massive burns, cultured epidermal autografts (CEA) were developed; however, CEA utilization has been limited by numerous factors. Non-cultured, autologous, cell suspension systems are alternatives to CEA. ReCell® is a system for the rapid, point-of-care preparation and application of non-cultured, autologous skin cells that provides an expansion ratio of 80:1. However, ReCell is not commercially available in the US. We present our compassionate use experience with ReCell, as an adjunct to STAG, in treating major burns at a single US Burn Center.

Methods

ReCell is an investigational device that is currently limited by US law to investigational use only. We were approved to use ReCell on select, major burns under a compassionate use protocol, and 13 patients have been treated to-date. ReCell was used as an adjunct to STAG in major, defined as >40% TBSA for adults and >25% for children, acute burns, whereby the ReCell suspension was over-sprayed onto widely meshed STAG and their donor sites. Outcomes for the adult ReCell-treated patients were compared to age and burn severity matched historical controls from our Burn Registry. We do not have an appropriate historic institutional control group for comparison of the ReCell-treated children, as we only started managing the pediatric burns in June 2014. Thus, the children were compared to age and burn severity matched controls from the American Burn Association National Burn Repository

Results

Eight adults (mean age of 34y and mean burn size of 63% TBSA) and 5 children (mean age of 1.3y and mean burn size of 36% TBSA) were treated. Mean total burn area treated with ReCell was 9644 cm2 in adults and 35% TBSA in children. There were no deaths in either the adult or the pediatric cohorts. Mean hospital length of stay was significantly reduced in adults, as compared to historic institutional controls (1.0 d vs. 1.9 d, p <0.0001). There was no observed LOS reduction for the treated children; however, all of the pediatric burns were the result of abuse and involved protracted social services interventions that added inpatient days beyond what was medically required. Long-term scarring and functional outcome assessments are on-going.

Conclusions

ReCell can be used in massive burns to, in effect, increase available donor skin elements and allow grafting of larger areas than would normally be possible, which appears to result in more rapid wound closure. Our compassionate use of ReCell appears to reduce hospital LOS via more rapid wound closure for both STAG and donor sites. However, larger studies are required, and are on-going, before widespread use is justified.

Key Words

ReCell, burns

Biography

Dr. Holmes is an Associate Professor of Surgery at Wake Forest University School of Medicine and Director of the Burn Center at the Wake Forest Baptist Medical Center in Winston-Salem, NC. His clinical specialty is burn/acute care surgery, with research interests in the development of skin substitutes and other alternatives to standard autografting of burn wounds. Dr. Holmes is also the Chair of the American Burn Association Multicenter Trials Group Steering Committee/Burn Science Advisory Panel. His investigative work has been supported by the National Institutes of Health, the US Department of Health & Human Services, and the Department of Defense.

About ANZBA

ANZBA is a not for profit organisation and the peak body for health professionals responsible for the care of the burn injured in Australia and New Zealand. ANZBA encourages higher standards of care through education, performance monitoring and research.

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