Norman Gill, Atkinson Ross A, Smith Tanya A, Rowlands Ceri, Rithalia Amber D, Crosbie Emma J, Dumville Jo C
Division of Nursing, Midwifery & Social Work, School of Health Sciences, Faculty of Biology, Medicine & Health, University of Manchester, Manchester Academic Health Science Centre, Jean McFarlane Building, Oxford Road, Manchester, UK, M13 9PL.
Cochrane Database Syst Rev. 2017 Oct 30;10(10):CD012234. doi: 10.1002/14651858.CD012234.pub2.
Surgical site infections (SSIs) are wound infections that occur after an operative procedure. A preventable complication, they are costly and associated with poorer patient outcomes, increased mortality, morbidity and reoperation rates. Surgical wound irrigation is an intraoperative technique, which may reduce the rate of SSIs through removal of dead or damaged tissue, metabolic waste, and wound exudate. Irrigation can be undertaken prior to wound closure or postoperatively. Intracavity lavage is a similar technique used in operations that expose a bodily cavity; such as procedures on the abdominal cavity and during joint replacement surgery.
To assess the effects of wound irrigation and intracavity lavage on the prevention of surgical site infection (SSI).
In February 2017 we searched the Cochrane Wounds Specialised Register; the Cochrane Central Register of Controlled Trials (CENTRAL); Ovid MEDLINE; Ovid Embase and EBSCO CINAHL Plus. We also searched three clinical trials registries and references of included studies and relevant systematic reviews. There were no restrictions on language, date of publication or study setting.
We included all randomised controlled trials (RCTs) of participants undergoing surgical procedures in which the use of a particular type of intraoperative washout (irrigation or lavage) was the only systematic difference between groups, and in which wounds underwent primary closure. The primary outcomes were SSI and wound dehiscence. Secondary outcomes were mortality, use of systemic antibiotics, antibiotic resistance, adverse events, re-intervention, length of hospital stay, and readmissions.
Two review authors independently assessed studies for inclusion at each stage. Two review authors also undertook data extraction, assessment of risk of bias and GRADE assessment. We calculated risk ratios or differences in means with 95% confidence intervals where possible.
We included 59 RCTs with 14,738 participants. Studies assessed comparisons between irrigation and no irrigation, between antibacterial and non-antibacterial irrigation, between different antibiotics, different antiseptics or different non-antibacterial agents, or between different methods of irrigation delivery. No studies compared antiseptic with antibiotic irrigation. Surgical site infectionIrrigation compared with no irrigation (20 studies; 7192 participants): there is no clear difference in risk of SSI between irrigation and no irrigation (RR 0.87, 95% CI 0.68 to 1.11; I = 28%; 14 studies, 6106 participants). This would represent an absolute difference of 13 fewer SSIs per 1000 people treated with irrigation compared with no irrigation; the 95% CI spanned from 31 fewer to 10 more SSIs. This was low-certainty evidence downgraded for risk of bias and imprecision.Antibacterial irrigation compared with non-antibacterial irrigation (36 studies, 6163 participants): there may be a lower incidence of SSI in participants treated with antibacterial irrigation compared with non-antibacterial irrigation (RR 0.57, 95% CI 0.44 to 0.75; I = 53%; 30 studies, 5141 participants). This would represent an absolute difference of 60 fewer SSIs per 1000 people treated with antibacterial irrigation than with non-antibacterial (95% CI 35 fewer to 78 fewer). This was low-certainty evidence downgraded for risk of bias and suspected publication bias.Comparison of irrigation of two agents of the same class (10 studies; 2118 participants): there may be a higher incidence of SSI in participants treated with povidone iodine compared with superoxidised water (Dermacyn) (RR 2.80, 95% CI 1.05 to 7.47; low-certainty evidence from one study, 190 participants). This would represent an absolute difference of 95 more SSIs per 1000 people treated with povidone iodine than with superoxidised water (95% CI 3 more to 341 more). All other comparisons found low- or very low-certainty evidence of no clear difference between groups.Comparison of two irrigation techniques: two studies compared standard (non-pulsed) methods with pulsatile methods. There may, on average, be fewer SSIs in participants treated with pulsatile methods compared with standard methods (RR 0.34, 95% CI 0.19 to 0.62; I = 0%; two studies, 484 participants). This would represent an absolute difference of 109 fewer SSIs occurring per 1000 with pulsatile irrigation compared with standard (95% CI 62 fewer to 134 fewer). This was low-certainty evidence downgraded twice for risks of bias across multiple domains. Wound dehiscenceFew studies reported wound dehiscence. No comparison had evidence for a difference between intervention groups. This included comparisons between irrigation and no irrigation (one study, low-certainty evidence); antibacterial and non-antibacterial irrigation (three studies, very low-certainty evidence) and pulsatile and standard irrigation (one study, low-certainty evidence). Secondary outcomesFew studies reported outcomes such as use of systemic antibiotics and antibiotic resistance and they were poorly and incompletely reported. There was limited reporting of mortality; this may have been partially due to failure to specify zero events in participants at low risk of death. Adverse event reporting was variable and often limited to individual event types. The evidence for the impact of interventions on length of hospital stay was low or moderate certainty; where differences were seen they were too small to be clinically important.
AUTHORS' CONCLUSIONS: The evidence base for intracavity lavage and wound irrigation is generally of low certainty. Therefore where we identified a possible difference in the incidence of SSI (in comparisons of antibacterial and non-antibacterial interventions, and pulsatile versus standard methods) these should be considered in the context of uncertainty, particularly given the possibility of publication bias for the comparison of antibacterial and non-antibacterial interventions. Clinicians should also consider whether the evidence is relevant to the surgical populations under consideration, the varying reporting of other prophylactic antibiotics, and concerns about antibiotic resistance.We did not identify any trials that compared an antibiotic with an antiseptic. This gap in the direct evidence base may merit further investigation, potentially using network meta-analysis; to inform the direction of new primary research. Any new trial should be adequately powered to detect a difference in SSIs in eligible participants, should use robust research methodology to reduce the risks of bias and internationally recognised criteria for diagnosis of SSI, and should have adequate duration and follow-up.
手术部位感染(SSIs)是指手术后发生的伤口感染。作为一种可预防的并发症,其成本高昂,且与较差的患者预后、死亡率增加、发病率及再次手术率相关。手术伤口冲洗是一种术中技术,可通过清除坏死或受损组织、代谢废物及伤口渗出液来降低手术部位感染率。冲洗可在伤口缝合前或术后进行。腔内灌洗是一种用于暴露体腔的手术(如腹腔手术及关节置换手术)中的类似技术。
评估伤口冲洗及腔内灌洗对预防手术部位感染(SSI)的效果。
2017年2月,我们检索了Cochrane伤口专业注册库、Cochrane对照试验中心注册库(CENTRAL)、Ovid MEDLINE、Ovid Embase及EBSCO CINAHL Plus。我们还检索了三个临床试验注册库以及纳入研究和相关系统评价的参考文献。对语言、出版日期或研究背景没有限制。
我们纳入了所有关于接受外科手术参与者的随机对照试验(RCTs),其中特定类型术中冲洗(冲洗或灌洗)的使用是组间唯一的系统差异,且伤口进行一期缝合。主要结局为手术部位感染和伤口裂开。次要结局为死亡率、全身抗生素的使用、抗生素耐药性、不良事件、再次干预、住院时间及再次入院情况。
两位综述作者在每个阶段独立评估纳入研究。两位综述作者还进行了数据提取、偏倚风险评估及GRADE评估。我们尽可能计算了风险比或均值差异及95%置信区间。
我们纳入了59项RCTs,共14738名参与者。研究评估了冲洗与不冲洗、抗菌冲洗与非抗菌冲洗、不同抗生素、不同防腐剂或不同非抗菌剂之间的比较,或不同冲洗给药方法之间的比较。没有研究比较防腐剂冲洗与抗生素冲洗。
手术部位感染
冲洗与不冲洗比较(20项研究;7192名参与者):冲洗与不冲洗在手术部位感染风险上无明显差异(RR 0.87,95% CI 0.68至1.11;I² = 28%;14项研究,6106名参与者)。这意味着每1000名接受冲洗治疗的人比不冲洗的人手术部位感染绝对减少13例;95% CI范围为减少31例至增加10例。这是低确定性证据,因偏倚风险和不精确性而降级。
抗菌冲洗与非抗菌冲洗比较(36项研究,6163名参与者):与非抗菌冲洗相比,接受抗菌冲洗的参与者手术部位感染发生率可能较低(RR 0.57,95% CI 0.44至0.75;I² = 53%;30项研究,5141名参与者)。这意味着每1000名接受抗菌冲洗的人比接受非抗菌冲洗的人手术部位感染绝对减少60例(95% CI减少35例至减少78例)。这是低确定性证据,因偏倚风险和疑似发表偏倚而降级。
同一类两种药物冲洗的比较(10项研究;2118名参与者):与超氧化水(Dermacyn)相比,接受聚维酮碘冲洗的参与者手术部位感染发生率可能较高(RR 2.80,95% CI 1.05至7.47;来自一项研究的低确定性证据,190名参与者)。这意味着每1000名接受聚维酮碘冲洗的人比接受超氧化水冲洗的人手术部位感染绝对增加95例(95% CI增加3例至增加341例)。所有其他比较发现组间无明显差异的证据质量低或极低。
两项研究比较了标准(非脉冲式)方法与脉冲式方法。与标准方法相比,接受脉冲式方法治疗的参与者平均手术部位感染可能较少(RR 0.34,95% CI 0.19至0.62;I² = 0%;两项研究,484名参与者)。这意味着每1000例接受脉冲式冲洗的人比接受标准冲洗的人手术部位感染绝对减少109例(95% CI减少62例至减少134例)。这是低确定性证据,因多个领域的偏倚风险而降级两次。
伤口裂开
很少有研究报告伤口裂开情况。没有比较显示干预组之间存在差异的证据。这包括冲洗与不冲洗之间的比较(一项研究,低确定性证据);抗菌冲洗与非抗菌冲洗之间的比较(三项研究,极低确定性证据)以及脉冲式冲洗与标准冲洗之间的比较(一项研究,低确定性证据)。
次要结局
很少有研究报告全身抗生素使用和抗生素耐药性等结局,且报告质量差且不完整。死亡率报告有限;这可能部分是由于未在低死亡风险参与者中明确零事件。不良事件报告不一,且通常限于个别事件类型。干预对住院时间影响的证据质量低或中等;即使观察到差异,也太小而无临床意义。
腔内灌洗和伤口冲洗的证据基础总体确定性较低。因此,在我们确定手术部位感染发生率可能存在差异的情况下(抗菌与非抗菌干预的比较以及脉冲式与标准方法的比较),应在不确定性背景下考虑这些差异,特别是考虑到抗菌与非抗菌干预比较可能存在发表偏倚。临床医生还应考虑证据是否与所考虑的手术人群相关、其他预防性抗生素报告的差异以及对抗生素耐药性的担忧。
我们未识别出任何比较抗生素与防腐剂的试验。直接证据基础中的这一差距可能值得进一步研究,可能采用网状Meta分析;为新的原始研究方向提供信息。任何新试验都应有足够的效能以检测符合条件参与者手术部位感染的差异,应采用稳健的研究方法以降低偏倚风险,并采用国际认可的手术部位感染诊断标准,且应有足够的持续时间和随访。