Department of Burn and Skin Surgery, First Affiliated Hospital of Air Force Military Medical University, No. 127 Changle West Road, Xincheng District, Xi'an, 710032, China.
Wuhan Third Hospital, Wuhan, China.
Arch Dermatol Res. 2024 Jun 21;316(7):417. doi: 10.1007/s00403-024-03007-y.
The indications for collagenase ointment (CO) and its efficacy are not clearly established in the treatment of second-degree burn wounds. To evaluate the efficacy of CO versus silver sulfadiazine ointment (SSD) in the treatment of second-degree burn wounds. A total of 170 eligible patients with deep second-degree burns, aged 18-65 years, with injuries occurring within 48-96 h, and having a total wound area of less than 30% of the total body surface area were included from 5 centers in China. The primary outcome was the wound healing time, and the secondary outcomes were the clearance time of wound necrotic tissues, wound healing rate, and wound inflammation. The study included 85 patients in SSD group and 84 in CO group in the modified intention-to-treat (mITT) population. The median time of wound healing was comparable in both groups (10 days vs. 10.5 days P = 0.16). The time for wound necrotic tissue removal was significantly shortened by CO compared with SSD (5 vs. 10 days P < 0.01). Wound inflammation, pain, wound healing rate, and scar were compared with SSD (all P-values > 0.05). No adverse events, such as infection or allergic reactions to the drugs and materials used, were reported. Both CO and SSD could heal the burn wounds at 10 days of treatment. However, CO significantly shortened the time of wound necrotic tissue removal by 5 days. Trial Registration: ChiCTR2100046971.
胶原酶软膏(CO)的适应证及其疗效在治疗二度烧伤创面中尚未明确。评估 CO 与磺胺嘧啶银软膏(SSD)治疗二度烧伤创面的疗效。在中国 5 个中心共纳入 170 名年龄在 18-65 岁、受伤时间在 48-96 小时内、总面积小于 30%的深二度烧伤患者,符合纳入排除标准。主要结局指标为创面愈合时间,次要结局指标为创面坏死组织清除时间、创面愈合率和创面炎症。SSD 组 85 例,CO 组 84 例,在改良意向治疗(mITT)人群中。两组患者的中位愈合时间相当(10 天比 10.5 天,P=0.16)。CO 组的创面坏死组织清除时间明显短于 SSD 组(5 天比 10 天,P<0.01)。与 SSD 相比,CO 在创面炎症、疼痛、愈合率和瘢痕方面均无显著差异(均 P 值>0.05)。未报告与药物和材料相关的不良反应,如感染或过敏。CO 和 SSD 在治疗 10 天后均可治愈烧伤创面,但 CO 可将创面坏死组织清除时间缩短 5 天。临床试验注册:ChiCTR2100046971。