围手术期补充氧气以降低高危骨折切开固定术后手术部位感染的随机对照试验

Perioperative supplemental oxygen to reduce surgical site infection after open fixation of high-risk fractures: a randomized controlled pilot trial.

机构信息

From the R Adams Cowley Shock Trauma Center, Department of Orthopaedics, University of Maryland School of Medicine, Baltimore, Maryland.

出版信息

J Trauma Acute Care Surg. 2013 Oct;75(4):657-63. doi: 10.1097/TA.0b013e3182a1fe83.

DOI:10.1097/TA.0b013e3182a1fe83

PMID:24064879

Abstract

BACKGROUND

Higher concentrations of fraction of inspired oxygen (FIO2) have been shown to be associated with lower risk for surgical site infection in multiple studies outside the domain of orthopedic surgery. We evaluated the efficacy of high FIO2 administered during the perioperative period to reduce the rate of surgical site infection after open fixation of lower-extremity fractures at high risk of infection.

METHODS

We conducted a randomized controlled, parallel design, double-blind study. Patients sustaining high-energy tibial plateau, tibial pilon, and calcaneus fractures treated in a staged fashion were selected for enrollment because these injuries are associated with high risk of infection. The study population included 222 patients with 235 fractures. Consenting patients were randomized by random number sequence to either the treatment or the control group. Treatment group patients received 80% FIO2 intraoperatively and for 2 hours afterward. Control group patients received 30% FIO2 during the same period. Surgeons, patients, and personnel who performed wound assessments were blinded to group assignment. The primary outcome measure was surgical site infection as defined by the Centers for Disease Control criteria for postoperative wound infection.

RESULTS

The overall rates of postoperative surgical site infection were 12% (14 of 119 fractures) in the treatment group and 16% (19 of 116 fractures) in the control group (p = 0.31). Multivariate analysis, accounting for risk factors for infection, yielded the closest to a statistically significant reduction in the odds of infection with treatment (odds ratio, 0.54; p = 0.17). No treatment-associated events were observed.

CONCLUSION

Use of a high concentration of FIO2 during the perioperative period is safe and shows a trend toward reduction of surgical site infection in patients undergoing open operative fixation of high-energy traumatic lower-extremity fractures. Further study in a larger patient population is indicated.

LEVEL OF EVIDENCE

Therapeutic study, level III.

摘要

背景

多项非骨科领域的研究表明，吸入氧分数（FIO2）浓度较高与手术部位感染风险降低相关。我们评估了围手术期给予高 FIO2 以降低感染高危下肢开放性骨折术后手术部位感染发生率的效果。

方法

我们进行了一项随机对照、平行设计、双盲研究。选择分期治疗的高能胫骨平台、胫骨pilon 和跟骨骨折患者入组，因为这些损伤与感染风险高相关。研究人群包括 222 名患者的 235 处骨折。同意入组的患者通过随机数序列随机分为治疗组或对照组。治疗组患者术中及术后 2 小时内接受 80%FIO2，对照组患者同期接受 30%FIO2。术者、患者和进行伤口评估的人员对分组情况均设盲。主要结局指标为根据术后伤口感染的疾病预防控制中心标准定义的手术部位感染。