[Translation] A multicenter, randomized, blinded, active-controlled phase IIIb clinical pilot trial to evaluate the efficacy and safety of recombinant lysostaphin paint in the treatment of deep IIo burn wounds complicated with methicillin-resistant Staphylococcus aureus (MRSA) infection
主要目的:初步评价重组溶葡萄球菌酶涂剂治疗深Ⅱo烧伤创面合并MRSA感染的完全创面闭合时间(天)。
次要目的:评价重组溶葡萄球菌酶涂剂治疗深Ⅱo烧伤创面合并MRSA感染的完全创面闭合发生率、创面愈合率、细菌学疗效、综合疗效和安全性。
[Translation] Primary objective: To preliminarily evaluate the time (days) for complete wound closure of deep Ⅱo burn wounds complicated with MRSA infection treated with recombinant lysostaphin.
Secondary objective: To evaluate the incidence of complete wound closure, wound healing rate, bacteriological efficacy, comprehensive efficacy and safety of recombinant lysostaphin in the treatment of deep Ⅱo burn wounds complicated with MRSA infection.