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

Abstract

　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.
　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）.
　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.
　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.