早期的酶性烧伤分解:DETECT多中心随机对照试验的结果
Yaron Shoham1, Lior Rosenberg1, William Hickerson2,3
1Department of Plastic Surgery and Burn Unit, Soroka University Medical Center, Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheba 8400711, Israel.
概括
使用NexoBrid进行的酶去除治疗有效地在深度烧伤患者中消除了,与标准护理相比,大大减少了手术和血液损失的必要性. 长期结果和痕是可比的,证明了NexoBridrid的结果.
科学领域:
- *燃烧管理和伤口愈合.
- * 皮肤病学和重建性手术.
- * 酶去bridement疗法. 酶去bridement疗法. 酶去bridement疗法. * 酶去bridement疗法. 酶去bridement疗法.
背景情况:
- * 传统的深度烧伤治疗依赖于手术除和自移植,这种方法始于1970年.
- * 需要使用不那么侵入性的除菌方法来改善患者的治疗结果,并减少外科手术负担.
研究的目的:
- * 评估使用NexoBrid进行酶解的有效性和安全性,用于深度烧伤管理.
- * 为了比较NexoBrid的有效性与标准护理 (SOC) 在瘤切除,手术干预和长期痕方面.
主要方法:
- *3期随机试验,涉及深度烧伤的成年患者 (3-30%的总体表面积[TBSA]).
- *患者被分配到NexoBrid,手术/非手术SOC或安慰剂凝车辆 (GV) 在3:3:1的比例.
- * 主要终点:完全切除骨 (ER);次要终点:需要手术,急诊时间,失血;安全性:伤口关闭,美化 (修改版温哥华痕量表 (MVSS)).
主要成果:
- *完整的骨切除 (ER) 在NexoBrid (93%) 与GV (4%) (P <.001) 中显著高.
- *与SOC (72%) 相比,NexoBrid组 (4%) 的外科切除明显较低 (P < .001).
- * NexoBrid (1.0天) 与SOC (3.8天) (P < .001) 的中位时间到ER更快,血液损失更少.
- *12个月和24个月的MVSS得分对于NexoBrid和SOC来说是不劣的,表明可比的长期痕.
结论:
- * NexoBrid在90%以上的深度烧伤患者中促进了早期和完整的骨移除.
- * 酶去bridement显著减少了手术的需要和相关的血液损失.
- *NexoBrid是一种安全且耐受性良好的SOC替代品,没有对伤口愈合或痕造成不良影响.
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