[Translation] A multicenter, randomized, open, positive-drug parallel-controlled phase II clinical trial of Shengji Zhitong Burn Ointment for the treatment of patients with deep second-degree burns
主要目的:比较广东颂德制药有限公司生产的生肌止痛烧伤膏与阳性对照药京万红软膏治疗 20cm2≤靶创面面积≤400cm2(面积最大不超过 2%总体表面积) 的深Ⅱ度烧伤创面的创面愈合时间。 次要目的:评价广东颂德制药有限公司生产的生肌止痛烧伤膏治疗 20cm2≤靶创面面积≤400cm2(面积最大不超过 2%总体表面积) 的深Ⅱ度烧伤创面创面愈合率、疼痛改善情况、镇痛药的使用情况、感染情况及安全性。
[Translation] Primary objective: To compare the wound healing time of deep second-degree burn wounds with a target wound area of 20cm2≤≤400cm2 (maximum area not exceeding 2% of the total surface area) treated with Shengji Zhitong Burn Ointment produced by Guangdong Songde Pharmaceutical Co., Ltd. and the positive control drug Jingwanhong Ointment. Secondary objective: To evaluate the wound healing rate, pain improvement, analgesic use, infection and safety of Shengji Zhitong Burn Ointment produced by Guangdong Songde Pharmaceutical Co., Ltd. in the treatment of deep second-degree burn wounds with a target wound area of 20cm2≤≤400cm2 (maximum area not exceeding 2% of the total surface area).