脱细胞同种异体真皮移植治疗下肢静脉溃疡:DAVE RCT。

IF 8.6 1区 医学 Q1 SURGERY
Sarah Onida, Matthew Tan, Valeria Balan, Francine Heatley, Sarrah Peerbux, Layla Bolton-Saghdaoui, Tristan Lane, David Epstein, Manjit Gohel, John Norrie, Robert Lee, Richard Lomas, Alun H Davies
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引用次数: 0

摘要

背景:下肢静脉溃疡(VLUs)对患者的生活质量(QoL)造成严重损害,高达30%的患者在6个月后不愈合。在随机对照试验中,脱细胞真皮(DCD)异体移植在提高糖尿病足溃疡的治愈率方面已被证明是有效的。DAVE随机对照试验旨在确定DCD是否是一种有效、安全、经济的vlu治疗辅助手段。方法:这是一项在英国进行的多中心随机对照试验。包括下肢溃疡≥18年伴VLU、双超声静脉功能不全、踝关节臂压指数≥0.8、VLU存在至少3个月且体积≥2 cm2的患者。患者被随机分配到干预组(DCD移植和标准护理组)或对照组(单独标准护理组)。主要终点是12周时溃疡愈合的患者比例。结果:2019年10月至2022年10月,36名参与者和35名参与者分别随机分为干预组和对照组。两组患者基线时的特征相似。干预组愈合率为5.7%,对照组为15.2% (OR = 0.34, 95% ci = 0.03 ~ 2.31)。次要结局包括溃疡面积变化百分比、愈合时间、复发率和生活质量没有显著差异。有5个严重不良事件归因于DCD的应用。中期数据分析后,由于主要转归率低于预期(11.3%),建议提前终止试验。结论:去细胞真皮移植物并没有提高腿部静脉溃疡的治愈率,尽管由于干预组和对照组的治愈率都很差,该试验被提前终止。由于样本量小,不能排除脱细胞真皮移植的重要临床益处或危害。试验注册:ISRCTN 21541209。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Decellularized dermis allograft for the treatment of venous leg ulceration: the DAVE RCT.

Background: Venous leg ulcers (VLUs) cause significant impairment to patients' quality of life (QoL) and up to 30% do not heal at 6 months. Decellularized dermis (DCD) allografts have been shown to be effective in improving healing rates of diabetic foot ulcers in RCTs. The DAVE RCT aimed to determine whether DCD is an effective, safe, and cost-effective treatment adjunct for VLUs.

Methods: This was a multicentre RCT performed in the UK. Patients with lower limb ulcers ≥18 years with VLU, venous incompetence on duplex ultrasound, an ankle : brachial pressure index ≥ 0.8 and an index VLU present for at least 3 months and ≥2 cm2 in size were included. Patients were randomized to either the intervention (DCD graft and standard of care) or control arm (standard of care alone). The primary outcome was the proportion of patients with a healed index ulcer at 12 weeks.

Results: From October 2019 to October 2022, 36 and 35 participants were randomized into the intervention and control arms respectively. Patient characteristics at baseline were similar between groups. Healing was recorded in 5.7% of the intervention group and 15.2% in the control group (OR 0.34, 95% c.i. 0.03 to 2.31). There were no significant differences in the secondary outcomes including the percentage change in ulcer area, time to healing, recurrence rates, and QoL. There were five serious adverse events attributed to DCD application. Early trial termination was advised after the interim data analysis due to a lower-than-expected primary outcome rate (11.3%).

Conclusions: Decellularized dermis grafts did not improve healing rates of venous leg ulcers, although the trial was terminated early due to poor healing rates in both the intervention and control arms. Important clinical benefits or harms of decellularized dermis grafts could not be excluded due to the small sample size.

Trial registration: ISRCTN 21541209.

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来源期刊
CiteScore
12.70
自引率
7.30%
发文量
1102
审稿时长
1.5 months
期刊介绍: The British Journal of Surgery (BJS), incorporating the European Journal of Surgery, stands as Europe's leading peer-reviewed surgical journal. It serves as an invaluable platform for presenting high-quality clinical and laboratory-based research across a wide range of surgical topics. In addition to providing a comprehensive coverage of traditional surgical practices, BJS also showcases emerging areas in the field, such as minimally invasive therapy and interventional radiology. While the journal appeals to general surgeons, it also holds relevance for specialty surgeons and professionals working in closely related fields. By presenting cutting-edge research and advancements, BJS aims to revolutionize the way surgical knowledge is shared and contribute to the ongoing progress of the surgical community.
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