The Results of a Phase ⅢClinical Trial for a Novel Enzymatic Debridement Agent KMW-1 in Japanese Patients with Deep Dermal Burn and Deep Burn

DOI
  • Nakazawa Hiroaki
    Department of Plastic and Reconstructive Surgery, Nihon University School of Medicine
  • Ikeda Hiroto
    Department of Emergency Medicine, Teikyo University School of Medicine
  • Ichinohashi Kohei
    Department of Emergency & Critical Care Medicine, Kindai University Faculty of Medicine
  • Ueda Takahiro
    Department of Emergency & Critical Care Medicine, Kindai University Faculty of Medicine Emergency and Critical Care Medical Center, Tottori University Hospital
  • Osuka Akinori
    Department of Trauma, Critical Care Medicine and Burn Center, Japan Community Healthcare Organization Chukyo Hospital
  • Kaita Yasuhiko
    Department of Trauma and Critical Care Medicine, Kyorin University School of Medicine
  • Kimura Chu
    Department of Plastic and Reconstructive Surgery, Hakodate Central General Hospital
  • Sakurai Hiroyuki
    Department of Plastic and Reconstructive Surgery, Tokyo Women's Medical University
  • Narimatsu Eichi
    Department of Emergency Medicine, Sapporo Medical University
  • Nishimura Gozo
    Department of Plastic Surgery, Fukuoka Tokushukai Hospital
  • Hashimoto Ichiro
    Department of Plastic and Reconstructive Surgery, Tokushima University Graduate School of Biomedical Sciences
  • Fujioka Masaki
    Department of Plastic and Reconstructive Surgery, National Hospital Organization Nagasaki Medical Center
  • Matsumura Hajime
    Department of Plastic and Reconstructive Surgery, Tokyo Medical University
  • Morioka Kousuke
    Department of Plastic and Reconstructive Surgery, Kagoshima City Hospital
  • Morita Naoki
    Department of Plastic and Reconstructive Surgery, Tokyo Metropolitan Hiroo Hospital
  • Urabe Yoshitaka
    Kaken Pharmaceutical Co., LTD.
  • Shoshi Keita
    Kaken Pharmaceutical Co., LTD.
  • Soejima Kazutaka
    Department of Plastic and Reconstructive Surgery, Nihon University School of Medicine

Bibliographic Information

Other Title
  • 深達性Ⅱ度またはⅢ度熱傷を有する日本人入院患者を対象とした新規壊死組織除去剤KMW-1の第3相臨床試験成績

Description

The usefulness of immediate excision has been long reported and it is a common practice. Excisional debridement is currently the most common therapy for burns; however, it has a high patient burden due to its invasiveness. KMW-1, a novel enzymatic debridement agent, has been reported in overseas clinical trials to be minimally invasive and to immediately remove eschar without harming viable tissues.<br>　We conducted a phaseⅢclinical trial to confirm the efficacy and safety of KMW-1 in Japanese patients with deep dermal burns（DDB）and deep burns（DB）.<br/>　The percentage of patients with complete removal of the eschar was 88.6%（95%CI［74.05, 95.46］）. The mean removed percentage of the eschar was 96.2% per patient and 97.1% per target wound. The median times to complete removal of the eschar were 1.0 and 3.0 days from the time of enrollment and injury, respectively. All side effects were mild to moderate. No adverse events requiring dose reduction, dose interruption, or dose discontinuation were reported.<br>　This study demonstrated that KMW-1 can be applied early, effectively, and selectively to remove eschar safely in Japanese patients with DDB and DB. Moreover, this agent may be an alternative method to immediate excision with excisional debridement.<br/>

Journal

Keywords

Details 詳細情報について

  • CRID
    1390573242608531840
  • DOI
    10.34366/jburn.48.1_1
  • ISSN
    24351571
    0285113X
  • Text Lang
    ja
  • Data Source
    • JaLC
  • Abstract License Flag
    Disallowed

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