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T3 Evaluation of Pediatric Population Treated for Burn Injuries Using an Autologous Skin Cell Suspension
Journal article   Peer reviewed

T3 Evaluation of Pediatric Population Treated for Burn Injuries Using an Autologous Skin Cell Suspension

J Carter, J Molnar, J Holmes, P Glat, W Davis, B Burkey, R Sheridan, R Sood, J Lee, K Foster, …
Journal of burn care & research, v 40(Supplement_1), pp S3-S3
09 Mar 2019
DOI: https://doi.org/10.1093/jbcr/irz013.002

Abstract

Abstract Introduction The 2016 NBR report indicates 30% of burns from 2006 to 2015 occurred in pediatric patients (ages 1–15). Management of burn injuries is based largely on depth, likelihood of healing within a timeframe associated with less chance of scarring, and donor skin availability. In deep burn injuries, split-thickness skin grafts (STSG) are used to heal the wound. However, the STSG donor site is frequently a source of morbidity and scarring. An alternative option to STSG, is to use autologous skin cell suspension (ASCS) prepared in the operating room at the point-of-care for the treatment of acute thermal burn injuries in patients ≥18 years. This technique allows for expansion of up to 80 times the area of STSG donor skin, with the end effect of minimizing donor site defect while maximizing wound coverage. The safety and effectiveness of ASCS has not been established in pediatric patients within the US. The purpose of this study is to present preliminary clinical outcomes obtained for pediatric patients with acute thermal burn injuries treated with ASCS from two FDA IDE on-going clinical studies, inclusive of a continued access protocol and compassionate use program. Methods Pediatric patients were included in the on-going studies as part of IDE 13053 (ages ≥5 years) and the compassionate use program IDE 15945 (no age restriction). Following surgical excision and wound bed preparation, ASCS was used in combination with widely meshed STSGs, with or without dermal substitutes for treatment of mixed depth or full-thickness burns. Wound healing was defined as the presence of ≥95% epithelialization. Adverse events were recorded including surgical intervention for graft failure or contracture release. Results To date, 33 patients were treated with ASCS ranging from 0.8 to 14.2 years of age. The mean TBSA was 46% (range 20–90%). Collectively, 195 burn wounds were treated. Healing data at 4 weeks post-treatment available for 176 wounds showed that 88.1% were healed. At 8 weeks, 92.4% of wounds were healed (n=145), and all wounds evaluated at one year (103 wounds, 17 patients) achieved definitive closure. Surgical intervention was required for graft failure in 8% of the wounds and for contracture release in 3% of wounds. Survival rate was 100%. Conclusions In these investigational studies, ASCS in combination with meshed STSG has been used successfully to achieve definitive closure for pediatric patients. Future studies are warranted to further objectively evaluate long-term functional and aesthetic outcomes. Applicability of Research to Practice Autologous skin cell suspension is a novel autograft-sparing technology at the patient’s point-of-care and may be a promising treatment option for pediatric burn patients.

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