Webster Joan, Scuffham Paul, Sherriff Karen L, Stankiewicz Monica, Chaboyer Wendy P
Centre for Clinical Nursing, Royal Brisbane and Women’s Hospital, Brisbane, Australia.
Cochrane Database Syst Rev. 2012 Apr 18(4):CD009261. doi: 10.1002/14651858.CD009261.pub2.
Indications for the use of negative pressure wound therapy (NPWT) are broadening with a range of systems on the market, including those designed for use on clean, closed incisions and skin grafts. Reviews have concluded that the evidence for the effectiveness of NPWT remains uncertain. However, this is a rapidly evolving therapy. Consequently, a systematic review of the evidence for the effects of NPWT on postoperative wounds expected to heal by primary intention is required.
To assess the effects of NPWT on surgical wounds (primary closure or skin grafting) that are expected to heal by primary intention.
We searched the following electronic databases to identify reports of relevant randomised clinical trials: the Cochrane Wounds Group Specialised Register (searched 11 November 2011); the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2011, Issue 4); Database of Abstracts of Reviews of Effects (The Cochrane Library 2011, Issue 4); Ovid MEDLINE (2005 to October Week 4 2011); Ovid MEDLINE (In-Process & Other Non-Indexed Citations 8 November 2011); Ovid EMBASE (2009 to 2011 Week 44); and EBSCO CINAHL (1982 to 04 November 2011). We conducted a separate search to identify economic evaluations.
We included trials if they allocated patients at random and compared NPWT with any other type of wound dressing or compared one type of NPWT with a different type of NPWT.
We assessed trials for their appropriateness for inclusion and for their quality. This was done by three review authors working independently, using pre-determined inclusion and quality criteria.
We included five eligible trials with a total of 280 participants. Two trials involved skin grafts and three acute wounds. Only one of the five trials reported the proportion of wounds completely healed and in this study all wounds healed. All five studies reported adverse events. In the four trials that compared standard dressings with negative pressure wound therapy (NPWT) the adverse event rate was similar between groups (negative pressure 33/86; standard dressing 37/103); risk ratio (RR) 0.97 (95% confidence intervals (CI) 0.33 to 2.89). There was significant heterogeneity for this result, due to the high incidence of fracture blisters in the NPWT group in one trial. One trial (87 participants) compared a commercial negative pressure device VAC® system with a negative pressure system developed in the hospital (GSUC). The adverse event rate was lower in the GSUC group (VAC® 3/42; GSUC 0/45); the RR was 0.13 (95% CI 0.01 to 2.51). Results indicate uncertainty about the true effect of either method on adverse events. The mean cost to supply equipment for VAC® therapy was USD 96.51/day compared to USD 4.22/day for the GSUC therapy (P = 0.01). Labour costs for dressing changes were similar. Pain intensity score was also reported to be lower in the GSUC group when compared with the VAC® group (p = 0.02)
AUTHORS' CONCLUSIONS: Evidence for the effectiveness of NPWT on complete healing of wounds expected to heal by primary intention remains unclear. Rates of graft loss may be lower when NPWT is used; but evidence to date suggests that hospital-based products are as effective in this area as commercial applications. There are clear cost benefits when non-commercial systems are used to create the negative pressure required for wound therapy, with no reduction in clinical outcome. Pain levels are also rated lower when hospital systems are compared with their commercial counterparts. The high incidence of blisters occurring when NPWT is used following orthopaedic surgery suggests that the therapy should be limited until safety in this population is established. Given the cost and widespread use of NPWT, there is an urgent need for suitably powered, high-quality trials to evaluate the effects of the newer NPWT products that are designed for use on clean, closed surgical incisions. Such trials should focus initially on wounds that may be difficult to heal, such as sternal wounds or surgeries for obese patients.
随着市场上一系列负压伤口治疗（NPWT）系统的出现，包括那些设计用于清洁、闭合切口和皮肤移植的系统，NPWT的使用指征正在扩大。综述得出结论，NPWT有效性的证据仍不明确。然而，这是一种快速发展的治疗方法。因此，需要对NPWT对预期一期愈合的术后伤口的影响进行系统综述。
评估NPWT对预期一期愈合的手术伤口（一期缝合或皮肤移植）的影响。
我们检索了以下电子数据库以识别相关随机临床试验报告：Cochrane伤口组专业注册库（2011年11月11日检索）；Cochrane对照试验中央注册库（CENTRAL）（Cochrane图书馆2011年第4期）；效果评价摘要数据库（Cochrane图书馆2011年第4期）；Ovid MEDLINE（2005年至2011年10月第4周）；Ovid MEDLINE（在研及其他未索引引用文献，2011年11月8日）；Ovid EMBASE（2009年至2011年第44周）；以及EBSCO CINAHL（1982年至2011年11月4日）。我们进行了一项单独检索以识别经济评价。
如果试验将患者随机分配，并将NPWT与任何其他类型的伤口敷料进行比较，或将一种类型的NPWT与另一种类型的NPWT进行比较，我们将其纳入。
我们评估试验是否适合纳入以及试验质量。这由三位综述作者独立完成，使用预先确定的纳入和质量标准。
我们纳入了五项符合条件的试验，共280名参与者。两项试验涉及皮肤移植，三项涉及急性伤口。五项试验中只有一项报告了伤口完全愈合的比例，在该研究中所有伤口均愈合。所有五项研究均报告了不良事件。在四项将标准敷料与负压伤口治疗（NPWT）进行比较的试验中，两组的不良事件发生率相似（负压组33/86；标准敷料组37/103）；风险比（RR）0.97（95%置信区间（CI）0.33至2.89）。由于一项试验中NPWT组骨折水疱发生率高，该结果存在显著异质性。一项试验（87名参与者）将一种商用负压设备VAC®系统与医院研发的负压系统（GSUC）进行了比较。GSUC组的不良事件发生率较低（VAC®组3/42；GSUC组0/45）；RR为0.13（95%CI 0.01至2.51）。结果表明两种方法对不良事件的真实影响存在不确定性。VAC®治疗的设备供应平均成本为每天96.51美元，而GSUC治疗为每天4.22美元（P = 0.01）。换药的人工成本相似。与VAC®组相比，GSUC组的疼痛强度评分也较低（p = 0.02）
NPWT对预期一期愈合的伤口完全愈合有效性的证据仍不明确。使用NPWT时移植失败率可能较低；但迄今为止的证据表明，医院自制产品在这方面与商业应用同样有效。使用非商业系统产生伤口治疗所需的负压有明显的成本效益，且临床结果无降低。与商业同类产品相比，医院系统的疼痛水平评分也较低。骨科手术后使用NPWT时水疱发生率高，表明在确定该人群的安全性之前，应限制该治疗方法。鉴于NPWT的成本和广泛使用，迫切需要开展有足够样本量的高质量试验来评估设计用于清洁、闭合手术切口的新型NPWT产品的效果。此类试验最初应聚焦于可能难以愈合的伤口，如胸骨伤口或肥胖患者的手术伤口。
