Background: 

Supplemental perioperative oxygen is a low-cost intervention theorized to reduce the risk of surgical site infections, but its effect among patients undergoing surgery for a tibial plateau, tibial pilon, or calcaneal fracture is unknown. We aimed to determine the effectiveness of a high fraction of inspired oxygen (FiO₂, 80%) versus low FiO₂ (30%) in reducing surgical site infections in these patients.

Methods: 

A randomized controlled trial was conducted at 29 U.S. trauma centers. We enrolled 1,231 patients who were 18 to 80 years of age and had a tibial plateau, tibial pilon, or calcaneal fracture and were thought to be at elevated risk for infection based on their injury characteristics. Patients were randomized to receive 80% FiO₂ (treatment group) or 30% FiO₂ (control group) in the operating room and for up to 2 hours in the recovery room. The primary outcome was a composite of either deep surgical site infection (treated with surgery) or superficial surgical site infection (treated with antibiotics alone) within 182 days following definitive fixation. Secondary outcomes included these surgical site infections at 90 and 365 days after surgery.

Results: 

The modified intention-to-treat analysis included 1,136 patients with 94% of expected follow-up through 182 days. Surgical site infection occurred in 40 (7.0%) of the patients in the treatment group and 60 (10.7%) of the patients in the control group (relative risk [RR], 0.65; 95% confidence interval [CI], 0.45 to 0.96; risk difference [RD], −3.8%; 95% CI, −7.2% to −0.4%; p = 0.03). The treatment intervention demonstrated a similar effect at 90 days (RR, 0.59; 95% CI, 0.37 to 0.93) and 365 days (RR, 0.62; 95% CI, 0.44 to 0.87). Secondary analyses demonstrated that the effect was driven by a reduction in superficial surgical site infections.

Conclusions: 

Among tibial plateau, pilon, or calcaneal fracture patients at elevated risk for surgical site infection, a high perioperative FiO₂ lowered the risk of surgical site infection. The findings support the use of this intervention, although the benefit appears to mostly be in reduction of superficial infections.

Level of Evidence: 

Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

中文翻译：

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围手术期吸氧对感染风险增加的下肢骨折成人 SSI 的影响：一项随机临床试验

背景： 

围手术期补充氧气是一种低成本的干预措施，理论上可以降低手术部位感染的风险，但它对接受胫骨平台、胫骨 pilon 或跟骨骨折手术的患者的影响尚不清楚。我们旨在确定高比例吸入氧气 (FiO ₂ , 80%) 与低 FiO ₂ (30%) 在减少这些患者手术部位感染方面的有效性。

方法： 

在 29 个美国创伤中心进行了一项随机对照试验。我们招募了 1,231 名 18 至 80 岁的患者，他们患有胫骨平台、胫骨 pilon 或跟骨骨折，并且根据他们的损伤特征被认为感染风险较高。患者被随机分配到在手术室接受 80% FiO ₂（治疗组）或 30% FiO ₂（对照组）并在恢复室接受长达 2 小时的治疗。主要结局是在最终固定后 182 天内由深部手术部位感染（经手术治疗）或浅表手术部位感染（仅用抗生素治疗）组成的复合结果。次要结果包括术后 90 天和 365 天的手术部位感染。

结果： 

改良的意向治疗分析包括 1,136 名患者，在 182 天内的预期随访率为 94%。治疗组 40 例 (7.0%) 患者和对照组 60 例 (10.7%) 患者发生手术部位感染（相对风险 [RR]，0.65；95% 置信区间 [CI]，0.45 至 0.96 ；风险差异 [RD]，-3.8%；95% CI，-7.2% 至 -0.4%；p = 0.03）。治疗干预在 90 天（RR，0.59；95% CI，0.37 至 0.93）和 365 天（RR，0.62；95% CI，0.44 至 0.87）时表现出相似的效果。二次分析表明，这种效果是由浅表手术部位感染减少引起的。

结论： 

在手术部位感染风险较高的胫骨平台、pilon 或跟骨骨折患者中，高围手术期 FiO ₂降低了手术部位感染的风险。研究结果支持使用这种干预措施，尽管好处似乎主要在于减少浅表感染。

证据等级： 

治疗一级。有关证据等级的完整描述，请参阅作者须知。