A novel rapid and selective enzymatic debridement agent for burn wound management: A multi-center RCT
A novel rapid and selective enzymatic debridement agent for burn wound management: A multi-center RCT
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DOI：
10.1016/j.burns.2013.08.013
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发表时间：
2014-05-01
期刊：
影响因子：
2.7
通讯作者：
Singer, Adam J.
中科院分区：
文献类型：
--
作者：
Rosenberg, Lior;Krieger, Yuval;Singer, Adam J.
目的：切除清创后自体移植是深度烧伤的标准治疗（SOC），但与严重的潜在并发症相关。保守、非手术和目前的酶清创方法效率低，速度慢。我们确定了使用清创酶NexoBrid（TM）（NXB）进行快速酶清创的非手术选择是否会减少手术需求，同时达到与SOC相似的美学和功能结果。方法：我们进行了一项多中心，开放标签，随机，对照临床试验，包括4-55岁的深度部分和全层烧伤患者，烧伤面积占总体表面积的5-30%（TBSA）。患者被随机分配到烧伤清创与NXB（应用4 h）或SOC，包括手术切除或非手术清创。NXB显著缩短了从损伤到完全清创的时间（2.2 vs. 8.7天，P < 0.0001），需要手术烧伤切除面积（13.1% vs. 56.7%，P <0.0001）和自体移植需要（17.9% vs. 34.1%，P = 0.01）。瘢痕质量和生活质量评分在两个研究组中相似，不良事件的发生率也相似。结论：与SOC相比，NXB酶清创术减少了手术的需要和程度，同时在深度烧伤患者中获得了相当的长期结果。(C)2013 Elsevier Ltd和ISBI。All rights reserved.
Objectives: Excisional debridement followed by autografting is the standard of care (SOC) for deep burns, but is associated with serious potential complications. Conservative, nonsurgical and current enzymatic debridement methods are inefficiently slow. We determined whether a non-surgical option of rapid enzymatic debridement with the debriding enzyme NexoBrid (TM) (NXB) would reduce need for surgery while achieving similar esthetic and functional outcomes as SOC.Methods: We conducted a multi-center, open-label, randomized, controlled clinical trial including patients aged 4-55 years with deep partial and full thickness burns covering 5-30% of their total body surface area (TBSA). Patients were randomly assigned to burn debridement with NXB (applied for 4 h) or SOC, which included surgical excisional or nonsurgical debridement.Results: NXB significantly reduced the time from injury to complete debridement (2.2 vs. 8.7 days, P < 0.0001), need for surgery (24.5% vs. 70.0%, P < 0.0001), the area of burns excised (13.1% vs. 56.7%, P < 0.0001) and the need for autografting (17.9% vs. 34.1%, P = 0.01). Scar quality and quality of life scores were similar in both study groups as were the rates of adverse events.Conclusions: Enzymatic debridement with NXB resulted in reduced need for and extent of surgery compared with SOC while achieving comparable long-term results in patients with deep burns. (C) 2013 Elsevier Ltd and ISBI. All rights reserved.