University of Manchester, Oxford Road, Manchester, M13 9PL, UK.
J Tissue Viability. 2019 Aug;28(3):152-160. doi: 10.1016/j.jtv.2019.04.001. Epub 2019 Apr 10.
This review investigated the current state of knowledge on negative pressure wound therapy (NPWT) used to treat diabetic foot ulceration (DFU), its clinical effectiveness and any current issues in the research. NICE have recommended research into the clinical effectiveness of different dressing types for DFUs since 2015.
A systematic search of the British Nursing Index, CINAHL, Cochrane Central and PubMed was undertaken. Only primary studies were included and studies investigating a combination of NPWT and other therapies were excluded. All the included studies were published in English between 2008 and 2018 and were peer reviewed.
The search yielded seven studies for inclusion in the qualitative analysis. The studies included a variety of methodologies specifically; 3 randomized controlled trials, 2 case series', 1 non-controlled trial and 1 randomized case-control study. Three main themes were identified and formed the focus of the qualitative synthesis.
All the included studies reported that NPWT led to better clinical outcomes when compared to standard treatment. However, the studies had numerous methodological flaws such as the absence of validated tools for the measurement of outcomes such as wound area and depth; a lack of statistical power calculations to determine adequate sample sizes or the significance of outcome measures. Additionally, there was little consistency in the pressures used for the NPWT devices. Finally, many of the controlled trials did not conform to the standard of reporting trials stipulated by the CONSORT statement.
本综述调查了目前用于治疗糖尿病足溃疡（DFU）的负压伤口治疗（NPWT）的知识现状、其临床效果以及研究中存在的问题。NICE 自 2015 年以来就建议研究不同敷料类型治疗 DFU 的临床效果。
对英国护理索引、CINAHL、Cochrane 中心和 PubMed 进行了系统检索。仅纳入初级研究，排除了同时调查 NPWT 和其他疗法的研究。所有纳入的研究均发表于 2008 年至 2018 年期间，且经过同行评审。
检索结果有 7 项研究纳入定性分析。这些研究采用了多种特定的方法学，包括 3 项随机对照试验、2 项病例系列研究、1 项非对照试验和 1 项随机病例对照研究。确定了 3 个主要主题，并成为定性综合的重点。
所有纳入的研究均报告 NPWT 与标准治疗相比可带来更好的临床结局。然而，这些研究存在许多方法学缺陷，例如缺乏用于测量结局（如伤口面积和深度）的验证工具；缺乏统计学功效计算来确定足够的样本量或结局测量的显著性。此外，NPWT 设备的压力也没有一致性。最后，许多对照试验不符合 CONSORT 声明规定的临床试验报告标准。
