Departments of Obstetrics and Gynecology, Santa Clara Valley Medical Center, San Jose, California, and Oregon Health and Science University, Portland, Oregon.
Obstet Gynecol. 2013 Jul;122(1):79-84. doi: 10.1097/AOG.0b013e318297ec6c.
To evaluate whether supplemental perioperative oxygen decreases surgical site wound infections or endometritis.
This was a prospective, randomized trial. Patients who were to undergo cesarean delivery were recruited and randomly allocated to either 30% or 80% oxygen during the cesarean delivery and for 1 hour after surgery. The obstetricians and patients were blinded to the concentration of oxygen used. Patients were evaluated for wound infection or endometritis during their hospital stay and by 6 weeks postpartum. The primary end point was a composite of either surgical site infection or endometritis.
Eight hundred thirty-one patients were recruited. Of these, 415 participants received 30% oxygen perioperatively and 416 received 80% oxygen. The groups were well matched for age, race, parity, diabetes, number of previous cesarean deliveries, and scheduled compared with unscheduled cesarean deliveries. An intention-to-treat analysis was used. There was no difference in the primary composite outcome (8.2% in women who received 30% oxygen compared with 8.2% in women who received 80% oxygen, P=.89), no difference in surgical site infection in the two groups (5.5% compared with 5.8%, P=.98), and no significant difference in endometritis in the two groups (2.7% compared with 2.4%, P=.66), respectively.
Women who received 80% supplemental oxygen perioperatively did not have a lower rate of a surgical site infection or endometritis as compared with women who received 30% supplemental oxygen concentration.
ClinicalTrials.gov, www.clincaltrials.gov, NCT00876005.
I.
评估围手术期补充氧气是否会降低手术部位的伤口感染或子宫内膜炎。
这是一项前瞻性、随机试验。招募了拟行剖宫产的患者,并随机分配至剖宫产期间和手术后 1 小时内接受 30%或 80%氧气。产科医生和患者对使用的氧气浓度均不知情。患者在住院期间和产后 6 周时评估伤口感染或子宫内膜炎。主要终点是手术部位感染或子宫内膜炎的复合结局。
共招募了 831 名患者。其中,415 名患者接受了围手术期 30%的氧气,416 名患者接受了 80%的氧气。两组在年龄、种族、产次、糖尿病、既往剖宫产次数、计划剖宫产与非计划剖宫产等方面匹配良好。采用意向治疗分析。两组主要复合结局(接受 30%氧气的女性为 8.2%,接受 80%氧气的女性为 8.2%,P=0.89)、两组手术部位感染(5.5%比 5.8%,P=0.98)和两组子宫内膜炎(2.7%比 2.4%,P=0.66)均无差异。
与接受 30%补充氧气浓度的女性相比,接受围手术期 80%补充氧气的女性手术部位感染或子宫内膜炎的发生率没有降低。
ClinicalTrials.gov,www.clincaltrials.gov,NCT00876005。
I 级。