Negative pressure wound therapy for skin grafts and surgical wounds healing by primary intention

  • Review
  • Intervention

Authors


Abstract

Background

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.

Objectives

To assess the effects of NPWT on surgical wounds (primary closure or skin grafting) that are expected to heal by primary intention.

Search methods

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.

Selection criteria

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.

Data collection and analysis

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.

Main results

We included five trials with a total of 280 participants. Two trials involved skin grafts, two included orthopaedic patients undergoing arthroplasty and one included general and trauma surgery patients; all had unclear or high risk of bias. Four trials compared NPWT with a standard dressing and one trial compared two NPWT devices. There were no differences in the proportion of wounds completely healed; the incidence of seromas; or failed skin grafts. One trial (87 participants) compared a commercial negative pressure device (VAC® KCI, San Antonio, Texas) with a negative pressure system developed in the hospital (GSUC). The wound complication 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). 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). One trial 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

There is no evidence for the effectiveness of NPWT on complete healing of wounds expected to heal by primary intention. There are clear cost benefits when non-commercial systems are used to create the negative pressure required for wound therapy, with no apparent 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.

摘要

負壓傷口治療用於皮膚移植與手術傷口癒合

背景

負壓傷口治療(negative pressure wound therapy, NPWT)的適應症隨著市場上系統的多樣化而擴展,包含用於乾淨、封閉傷口與皮膚移植的照護。目前文獻回顧的結果,針對負壓傷口治療有效性之證據仍無法確定。然而,這是快速興起的治療方法。因此,針對負壓傷口治療對於促進術後傷口癒合效果的系統文獻回顧是必需的。

目標

評估負壓傷口治療對於手術傷口(主要為閉合性或皮膚移植)之效果。

搜尋策略

我們搜尋了下列電子資料庫以找出相關隨機臨床試驗的報告:考科藍傷口專業註冊試驗(搜尋至2011年11月11日); CENTRAL(The Cochrane Library 2011, Issue 4); Database of Abstracts of Reviews of Effects (The Cochrane Library 2011, Issue 4);Ovid MEDLINE(2005年到2011年10月第4週); Ovid MEDLINE(進行中與其它非索引引用2011年11月8日);Ovid EMDASE(2009年到2011年第44週);以及EBSCO CINAHL(1982年到2011年11月4日)。我們進行分別的搜尋,以找出經濟評估(economic evaluations)。

選擇標準

若試驗以隨機方式分配病人,並比較負壓傷口治療與其它傷口敷料類型;或是比較不同的負壓傷口治療類型的試驗,納入本回顧中。

資料收集與分析

我們評估了試驗是否符合納入標準,並評估其研究品質。這個過程由3位作者使用預定的納入、及研究品質標準獨立作業完成。

主要結論

我們採用了5個試驗總共有280位參與者。2個試驗涉及皮膚移植,2個包含了進行關節置換的骨科病人,還有一個包含一般與創傷外科病人。所有的試驗都具有不確定的或高的偏差風險。4個試驗比較了負壓傷口治療與標準敷料,而1個試驗比較兩種負壓傷口治療裝置。這些研究的結果,在傷口完全癒合比例、血腫發生或皮膚移植失敗率方面,沒有差異。1個試驗(87名參與者)比較了商用負壓儀器(VAC® KCI, San Antonio, Texas)與醫院中發展出來的負壓系統(GSUC)。使用GSUC者,傷口併發症發生率較低(VAC® 3/42; GSUC 0/45;RR 0.1395% CI 0.01到2.51)。使用VAC®治療設備的平均成本為美金96.51/天,較GSUCUSD4.22/天高(P=0.01)。兩組在更換敷料的人力成本上類似。相較於VAC組,使用GSUC組之疼痛強度分數也較低(P=0.02)。一個試驗提早停止,因為在負壓傷口治療組中,骨折水泡(fracture blisters)的發生率較高(15/24;62.5%),與標準敷料群組相比(3/36;8.3%)(RR 7.50;95% CI 2.43到23.14)。

作者結論

沒有證據支持負壓傷口治療用於促進傷口癒合上的有效性。在採用非商業系統以建立傷口治療所需的負壓時,有明顯的成本益處,對臨床效果方面卻沒有明顯的降低。當醫院系統與類似的商業系統比較時,疼痛水準也較低。骨科手術後使用負壓傷口治療,發生水泡機率較高,這個研究結果顯示,除非在這個族群使用負壓傷口治療的安全性被建立,否則,此治療應被限制。在使用負壓傷口治療的成本與廣泛使用的前提下,有適當效力、高品質的試驗以評估其對於清淨、封閉式手術切口上使用的效果有急切的需要。此類試驗初期應著重在可能難以癒合的傷口上(如胸骨傷口),或肥胖病人的手術傷口上。

Plain language summary

Negative pressure wound therapy for acute surgical wounds.

Negative pressure wound therapy (NPWT) involves applying suction to healing wounds. NPWT has been used for many years for the treatment of chronic wounds, such as leg ulcers and bed sores. More recently, the device has been modified for use on clean surgical wounds, including skin grafts. We undertook a review of studies that have compared NPWT with other wound treatments. We found five trials which showed that evidence to support the use of NPWT to promote faster healing and to reduce complications associated clean surgery remains unclear.

總結

負壓傷口治療用於皮膚移植與手術傷口癒合

負壓傷口治療用於急性手術傷口治療。

負壓傷口治療涉及利用抽吸促進傷口癒合。負壓傷口治療已於慢性傷口治療中使用多年,像是下肢潰瘍與褥瘡。近來,儀器調整為可用於乾淨的手術傷口,包含皮膚移植。我們進行了系統性文獻回顧,進行使用負壓傷口治療與其它傷口治療之比較。我們找到5個試驗,結果顯示使用負壓傷口治療可促進手術乾淨傷口的癒合或降低併發症之證據仍不明確。

譯註

East Asian Cochrane Alliance 翻譯
翻譯由 台灣衛生福利部/台北醫學大學實證醫學研究中心 資助

Ancillary