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

ABSTRACT 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 cm2 (for intervention and control sites of 100 cm2 each) were enrolled. INTERVENTION: A cultured epithelial allograft containing 2 × 107/1.5 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
Source: Advances in Skin and Wound Care - Category: Dermatology Tags: Features: Case Series Source Type: research