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A Murine Model of a Burn Wound Reconstructed with an Allogeneic Skin Graft
Published on: August 8, 2020
Effectiveness and Safety of a Thermosensitive Hydrogel Cultured Epidermal Allograft for Burns
Jaechul Yoon1, Hyeong-Tae Yang, Haejun Yim
1At the Burn Center, Hangang Sacred Heart Hospital, Hallym University Medical Center, Seoul, Republic of Korea, Jaechul Yoon, MD, is Clinical Assistant Professor; Hyeong-Tae Yang, MD, is Assistant Professor; Haejun Yim, MD, is Assistant Professor; Yong-Suk Cho, MD, is Associate Professor; Dohern Kym, MD, is Associate Professor; Jun Hur, MD, is Associate Professor; Wook Chun, MD, is Professor; and Jong-Wook Lee, MD, is a Professor. Chunjae Yoon, MD, is Department Head of the Burn Center, Bestian Hospital, Seoul, Republic of Korea.
Objective:
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.
Design And Setting:
Prospective interventional phase 3 study in 3 burn centers near Seoul, South Korea.
Patients:
Thirty-three patients with deep second-degree burns larger than 200 cm (for intervention and control sites of 100 cm each) were enrolled.
Intervention:
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.
Main Outcome Measure:
The primary end point of the study was the re-epithelialization period.
Main Results:
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.
Conclusuions:
This type of cultured epithelial allograft is safe and well received by patients and providers and promotes re-epithelialization.
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