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Keywords

burn dressing, cultured epidermal allograft, preconfluent allogeneic keratinocytes, second-degree burn, thermosensitive hydrogel

 

Authors

  1. Yoon, Jaechul MD
  2. Yang, Hyeong-Tae MD
  3. Yim, Haejun MD
  4. Cho, Yong-Suk MD
  5. Kym, Dohern MD
  6. Hur, Jun MD
  7. Chun, Wook MD
  8. Lee, Jong-Wook MD
  9. Yoon, Chunjae MD

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 x 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.