Ehlers Anne P, Khor Sara, Shonnard Neal, Oskouian Rod J, Sethi Rajiv K, Cizik Amy M, Lee Michael J, Bederman Samuel, Anderson Paul A, Dellinger E Patchen, Flum David R
1 Department of Surgery, University of Washington , Seattle, Washington.
2 Surgical Outcomes Research Center, University of Washington , Seattle, Washington.
Surg Infect (Larchmt). 2016 Apr;17(2):179-86. doi: 10.1089/sur.2015.146. Epub 2016 Feb 2.
Surgical site infection (SSI) after spine surgery is classified as a "never event" by the Centers for Medicare and Medicaid. Intra-wound antibiotics (IWA) have been proposed to reduce the incidence of SSI, but robust evidence to support its use is lacking.
Prospective cohort undergoing spine fusion at 20 Washington State hospitals (July 2011 to March 2014) participating in the Spine Surgical Care and Outcomes Assessment Program (Spine SCOAP) linked to a discharge tracking system. Patient, hospital, and operative factors associated with SSI and IWA use during index hospitalizations through 600 days were analyzed using a random effects logistic model (index), and a time-to-event analysis (follow-up) using Cox proportional hazards.
A total of 9,823 patients underwent cervical (47%) or lumbar (53%) procedures (mean age, 58; 54% female) with an SSI rate of 1.1% during index hospitalization. Those with SSI were older, more often had diabetes mellitus, and more frequently underwent lumbar (versus cervical) fusion compared with those without SSI (all p < 0.01). Unadjusted rates of SSI during index hospitalization were lower in patients who received IWA (0.8% versus 1.5%). After adjustment for patient, hospital, and operative factors, no benefit was observed in those receiving IWA (odds ratio [OR] 0.65, 95% confidence interval [CI]: 0.42-1.03). At 12 mo, unadjusted rates of SSI were 2.4% and 3.0% for those who did and did not receive antibiotics; after adjustment there was no significant difference (hazard ratio [HR] 0.94, 95% CI: 0.62-1.42).
Whereas unadjusted analyses indicate a nearly 50% reduction in index SSI using IWA, we did not observe a statistically significant difference after adjustment. Despite its size, this study is underpowered to detect small but potentially relevant improvements in rates of SSI. It remains to be determined if IWA should be promoted as a quality improvement intervention. Concerns related to bias in the use of IWA suggest the benefit of a randomized trial.
脊柱手术后手术部位感染(SSI)被医疗保险和医疗补助服务中心列为“绝不允许发生的事件”。伤口内使用抗生素(IWA)已被提议用于降低SSI的发生率,但缺乏有力证据支持其使用。
在20家华盛顿州医院(2011年7月至2014年3月)进行脊柱融合手术的前瞻性队列研究,这些医院参与了与出院追踪系统相关联的脊柱外科护理与结果评估项目(Spine SCOAP)。通过随机效应逻辑模型(索引)分析与初次住院期间至600天内SSI和IWA使用相关的患者、医院和手术因素,并使用Cox比例风险模型进行事件发生时间分析(随访)。
共有9823例患者接受了颈椎(47%)或腰椎(53%)手术(平均年龄58岁;54%为女性),初次住院期间SSI发生率为1.1%。与未发生SSI的患者相比,发生SSI的患者年龄更大,更常患有糖尿病,且更频繁地接受腰椎(而非颈椎)融合手术(所有p<0.01)。接受IWA的患者初次住院期间未调整的SSI发生率较低(0.8%对1.5%)。在对患者、医院和手术因素进行调整后,接受IWA的患者未观察到益处(优势比[OR]0.65,95%置信区间[CI]:0.42 - 1.03)。在12个月时,接受和未接受抗生素的患者未调整的SSI发生率分别为2.4%和3.0%;调整后无显著差异(风险比[HR]0.94,95%CI:0.62 - 1.42)。
尽管未调整分析表明使用IWA可使初次住院期间的SSI降低近50%,但调整后我们未观察到统计学上的显著差异。尽管本研究规模较大,但检测SSI发生率微小但可能相关的改善的能力不足。IWA是否应作为质量改进干预措施推广仍有待确定。与IWA使用中的偏倚相关的问题表明需要进行随机试验。