Gregor Sven, Maegele Marc, Sauerland Stefan, Krahn Jan F, Peinemann Frank, Lange Stefan
Institute for Research in Operative Medicine, University of Witten/Herdecke, Ostmerheimer Str 200, 51109 Cologne, Germany.
Arch Surg. 2008 Feb;143(2):189-96. doi: 10.1001/archsurg.2007.54.
To systematically examine the clinical effectiveness and safety of negative pressure wound therapy (NPWT) compared with conventional wound therapy.
MEDLINE, EMBASE, CINAHL, and the Cochrane Library were searched. Manufacturers were contacted, and trial registries were screened.
Randomized controlled trials (RCTs) and non-RCTs comparing NPWT and conventional therapy for acute or chronic wounds were included in this review. The main outcomes of interest were wound-healing variables. After screening 255 full-text articles, 17 studies remained. In addition, 19 unpublished trials were found, of which 5 had been prematurely terminated.
Two reviewers independently extracted data and assessed methodologic quality in a standardized manner.
Seven RCTs (n = 324) and 10 non-RCTs (n = 278) met the inclusion criteria. The overall methodologic quality of the trials was poor. Significant differences in favor of NPWT for time to wound closure or incidence of wound closure were shown in 2 of 5 RCTs and 2 of 4 non-RCTs. A meta-analysis of changes in wound size that included 4 RCTs and 2 non-RCTs favored NPWT (standardized mean difference: RCTs, -0.57; non-RCTs, -1.30).
Although there is some indication that NPWT may improve wound healing, the body of evidence available is insufficient to clearly prove an additional clinical benefit of NPWT. The large number of prematurely terminated and unpublished trials is reason for concern.
系统评估负压伤口治疗（NPWT）与传统伤口治疗相比的临床有效性和安全性。
检索了MEDLINE、EMBASE、CINAHL和Cochrane图书馆。联系了制造商，并筛选了试验注册库。
本综述纳入了比较NPWT与传统疗法治疗急性或慢性伤口的随机对照试验（RCT）和非RCT。主要关注的结局是伤口愈合变量。在筛选了255篇全文文章后，剩下17项研究。此外，还发现了19项未发表的试验，其中5项已提前终止。
两名研究者以标准化方式独立提取数据并评估方法学质量。
7项RCT（n = 324）和10项非RCT（n = 278）符合纳入标准。试验的总体方法学质量较差。5项RCT中的2项和4项非RCT中的2项显示，在伤口闭合时间或伤口闭合发生率方面，NPWT有显著优势。一项纳入4项RCT和2项非RCT的伤口大小变化的荟萃分析支持NPWT（标准化均数差：RCT为-0.57；非RCT为-1.30）。
尽管有迹象表明NPWT可能改善伤口愈合，但现有证据不足以明确证明NPWT具有额外的临床益处。大量提前终止和未发表的试验令人担忧。
