Webster Joan, Scuffham Paul, Stankiewicz Monica, Chaboyer Wendy P
Centre for Clinical Nursing, Royal Brisbane and Women's Hospital, Level 2, Building 34, Butterfield Street, Brisbane, Queensland, Australia, 4029.
Cochrane Database Syst Rev. 2014 Oct 7(10):CD009261. doi: 10.1002/14651858.CD009261.pub3.
Indications for the use of negative pressure wound therapy (NPWT) are broadening with a range of systems now available 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, it is a rapidly evolving therapy. Consequently, an updated 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, skin grafting or flap closure) 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 28 January 2014); the Cochrane Central Register of Controlled Trials (CENTRAL; 2013, issue 12); Database of Abstracts of Reviews of Effects (2013, issue 12); Ovid MEDLINE (2011 to January 2014); Ovid MEDLINE (In-Process & Other Non-Indexed Citations 24 January 2014); Ovid EMBASE (2011 to January 2014 Week 44); and EBSCO CINAHL (2011 to January 2014). We conducted a separate search to identify economic evaluations.
We included trials if they allocated patients to treatment randomly 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.
In this first update, we included an additional four trials, taking the total number of trials included to nine (785 participants). Three trials involved skin grafts, four included orthopaedic patients and two included general surgery and trauma surgery patients; all the included trials had unclear or high risk of bias for one or more of the quality indicators we assessed. Seven trials compared NPWT with a standard dressing (two of these were 'home-made' NPWT devices), one trial compared one 'home-made' NPWT with a commercially available device. In trials where the individual was the unit of randomisation, there were no differences in the incidence of surgical site infections (SSI); wound dehiscence, re-operation (in incisional wounds); seroma/haematoma; or failed skin grafts. Lower re-operation rates were observed among skin graft patients in the 'home-made' NPWT group (7/65; 10.8%) compared to the standard dressing group (17/66; 25.8%) (risk ratio (RR) 0.42; 95% CI 0.19 to 0.92). The mean cost to supply equipment for VAC® therapy was USD 96.51/day compared to USD 4.22/day for one of the 'home-made' devices (P value 0.01); labour costs for dressing changes were similar for both treatments. Pain intensity score was also reported to be lower in the 'home-made' group when compared with the VAC® group (P value 0.02). One of the trials in orthopaedic patients was stopped early because of a high incidence of fracture blisters in the NPWT group (15/24; 62.5%) compared with the standard dressing group (3/36; 8.3%) (RR 7.50; 95% CI 2.43 to 23.14).
AUTHORS' CONCLUSIONS: Evidence for the effects of negative pressure wound therapy (NPWT) for reducing SSI and wound dehiscence remains unclear, as does the effect of NPWT on time to complete healing. Rates of graft loss may be lower when NPWT is used, but hospital-designed and built 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 evidence of a negative effect on clinical outcome. In one study, pain levels were also rated lower when a 'home-made' system was compared with a commercial counterpart. 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 incisions on obese patients.
随着市场上现有一系列负压伤口治疗(NPWT)系统,包括设计用于清洁、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有效性的证据仍不确定,然而,它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更新的系统综述。
评估NPWT对预期一期愈合的手术伤口(一期缝合、皮肤移植或皮瓣闭合)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(2014年1月28日检索);Cochrane对照试验中央注册库(CENTRAL;2013年第12期);效果综述文摘数据库(2013年第12期);Ovid MEDLINE(2011年至2014年1月);Ovid MEDLINE(在研及其他未索引引文,2014年1月24日);Ovid EMBASE(2011年至2014年第44周);以及EBSCO CINAHL(2011年至2014年1月)。我们进行了单独检索以识别经济评估。
如果试验将患者随机分配至治疗组,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,我们则纳入该试验。
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进行,使用预先确定的纳入标准和质量标准。
在本次首次更新中,我们额外纳入了四项试验,使纳入试验总数达到九项(785名参与者)。三项试验涉及皮肤移植,四项纳入骨科患者,两项纳入普通外科和创伤外科患者;所有纳入试验在我们评估的一个或多个质量指标方面存在不明确或高偏倚风险。七项试验将NPWT与标准敷料进行比较(其中两项为“自制”NPWT装置),一项试验将一种“自制”NPWT与市售装置进行比较。在以个体为随机化单位的试验中,手术部位感染(SSI)发生率、伤口裂开、再次手术(在切口伤口中)、血清肿/血肿或皮肤移植失败方面无差异。与标准敷料组(17/66;25.8%)相比,“自制”NPWT组皮肤移植患者的再次手术率较低(7/65;10.8%)(风险比(RR)0.42;95%置信区间0.19至0.92)。VAC®治疗的设备供应平均成本为96.51美元/天,而其中一种“自制”装置为4.22美元/天(P值0.01);两种治疗的换药人工成本相似。与VAC®组相比,“自制”组的疼痛强度评分也较低(P值0.02)。骨科患者的一项试验提前终止,因为NPWT组骨折水疱发生率较高(15/24;62.5%),而标准敷料组为(3/36;8.3%)(RR 7.50;95%置信区间2.43至23.14)。
负压伤口治疗(NPWT)对降低SSI和伤口裂开影响的证据仍不明确,NPWT对完全愈合时间的影响也是如此。使用NPWT时移植失败率可能较低,但医院设计和制造的产品在这方面与商业应用一样有效。使用非商业系统产生伤口治疗所需的负压具有明显的成本效益,且没有证据表明对临床结果有负面影响。在一项研究中,与市售同类产品相比,“自制”系统的疼痛水平也较低。骨科手术后使用NPWT时水疱发生率较高,这表明在确定该人群的安全性之前应限制使用该治疗方法。鉴于NPWT的成本和广泛使用,迫切需要进行适当规模且高质量的试验,以评估设计用于清洁、闭合手术切口的新型NPWT产品的效果。此类试验最初应关注可能难以愈合的伤口,如胸骨伤口或肥胖患者的切口。