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Effectiveness and Safety of a Thermosensitive Hydrogel Cultured Epidermal Allograft for Burns.

Research paper by Jaechul J Yoon, Hyeong-Tae HT Yang, Haejun H Yim, Yong-Suk YS Cho, Dohern D Kym, Jun J Hur, Wook W Chun, Jong-Wook JW Lee, Chunjae C Yoon

Indexed on: 16 Nov '17Published on: 16 Nov '17Published in: Advances in skin & wound care



Abstract

To retest the safety and effectiveness of a thermosensitive hydrogel-type cultured epithelial allograft (KeraHeal-Allo; MCTT, Seoul, South Korea) and identify the subjective experience of patients and doctors with this product.Prospective interventional phase 3 study in 3 burn centers near Seoul, South Korea.Thirty-three patients with deep second-degree burns larger than 200 cm (for intervention and control sites of 100 cm each) were enrolled.A cultured epithelial allograft containing 2 × 10/1.5 mL keratinocytes was applied to each patient's intervention site. Three principal investigators (1 in each institution) evaluated the effectiveness of the allograft at their institution and the others'. Researchers administered a subjective satisfaction survey during each patient's last visit.The primary end point of the study was the re-epithelialization period.The re-epithelialization period for the intervention was 2.8 ± 2.2 days faster than that of control sites at other institutions (P < .001) and 2.5 ± 3.4 days faster than that of control sites in the same institution (P < .001). There were no reported adverse events. Satisfaction scores provided by patients and doctors showed significantly high scores on all items.This type of cultured epithelial allograft is safe and well received by patients and providers and promotes re-epithelialization.