23693
2018-08-08 07:15:57
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The PMA submission includes clinical data from the two U.S. randomized, controlled trials with combined enrollment of 131 patients at twelve leading burn centers across the United States. The later trial demonstrated over 30% reduction in donor skin harvesting while achieving comparable near-term healing and long-term scar outcomes for treatment of third-degree burn injuries. Results from the earlier trial demonstrate a 97.5% reduction in donor skin harvested for treatment of second-degree burn injuries.
임상시험 결과 이 치료를 병행하면 2도 화상 환자들에서 자가 피부이식 필요환자 수가 97.5% 감소, 상처 감소효과. 3도 화상 환자들에게서 30%감소. 상처가 진피층을 넘어 깊어지면 깊어질 수록 기존의 자가 피부이식이 필요하게 되지만 그럼에도 불구하고 3도 화상도 어느정도 복구가 되네요.