Rosenberg L, Shoham Y, Krieger Y, Rubin G, Sander F, Koller J, David K, Egosi D, Ahuja R, Singer A J
Department of Plastic and Reconstructive Surgery and the burn Unit, Soroka University medical Centre, Faculty of health Sciences, ben-Gurion University, beer-Sheva, israel; Cleft Lip and Palate and Craniofacial Deformities Unit, Department of Plastic Surgery, meir hospital, kfar Saba, israel; Clinical and medical Departments, mediWound LTD, Yavneh, israel.
Department of Plastic and Reconstructive Surgery and the burn Unit, Soroka University medical Centre, Faculty of health Sciences, ben-Gurion University, beer-Sheva, israel.
Ann Burns Fire Disasters. 2015 Dec 31;28(4):264-274.
Current surgical and non-surgical eschar removal-debridement techniques are invasive or ineffective. A bromelainbased rapid and selective enzymatic debriding agent was developed to overcome these disadvantages and compared with the standard of care (SOC). The safety and efficacy of a novel Debriding Gel Dressing (DGD) was determined in patients with deep partial and full thickness burns covering up to 67% total body surface area (TBSA). This review summarizes data from seven studies, four of which were randomized clinical trials that included a SOC or control vehicle. DGD eschar debridement efficacy was >90% in all studies, comparable to the SOC and significantly greater than the control vehicle. The total area excised was less in patients treated with DGD compared with the control vehicle (22.9% vs. 73.2%, P<0.001) or the surgical/non-surgical SOC (50.5%, P=0.006). The incidence of surgical debridement in patients treated with DGD was lower than the SOC (40/163 [24.5%] vs. 119/170 [70.0%], P0.001). Less autografting was used in all studies. Long-term scar quality and function were similar in DGD- and SOCtreated. DGD is a safe and effective method of burn debridement that offers an alternative to surgical and non-surgical SOC.
当前的手术和非手术焦痂清除——清创技术具有侵入性或效果不佳。一种基于菠萝蛋白酶的快速选择性酶促清创剂被研发出来以克服这些缺点,并与护理标准(SOC)进行了比较。在全身表面积(TBSA)覆盖高达67%的深度部分和全层烧伤患者中确定了一种新型清创凝胶敷料(DGD)的安全性和有效性。本综述总结了七项研究的数据,其中四项为随机临床试验,包括SOC或对照载体。在所有研究中,DGD焦痂清创效果>90%,与SOC相当且显著优于对照载体。与对照载体(22.9%对73.2%,P<0.001)或手术/非手术SOC(50.5%,P=0.006)相比,接受DGD治疗的患者切除的总面积更少。接受DGD治疗的患者手术清创的发生率低于SOC(40/163[24.5%]对119/170[70.0%],P<0.001)。在所有研究中使用的自体移植更少。DGD治疗组和SOC治疗组的长期瘢痕质量和功能相似。DGD是一种安全有效的烧伤清创方法,为手术和非手术SOC提供了一种替代方案。