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

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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 < .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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