Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.
Student Research Committee, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.
Antimicrob Resist Infect Control. 2022 Dec 5;11(1):150. doi: 10.1186/s13756-022-01191-y.
Cesarean section (CS) is the most frequently performed surgery in the United States. Compared to vaginal delivery, CS has a higher risk of maternal and neonatal mortality, morbidities, and complications, among which surgical site infection (SSI) is the most common. We aimed at evaluating the effectiveness of postoperative oral administration of cephalexin and metronidazole on SSI among obese women undergoing CS.
We conducted a randomized, double-blind clinical trial comparing the prophylactic effect of oral cephalexin and metronidazole vs cephalexin and placebo on SSI following CS among obese women. who had received preoperative prophylactic cephalosporin antibiotics. The study was conducted at the Ommolbanin Hospital, affiliated with Mashhad University of Medical Sciences from April 2019 to February 2020.
The participants were randomized into the intervention group (n = 210) and the control group (n = 210). At week-1 follow-up, the outcomes were significantly lower in the intervention group as compared to the control group in terms of fever (9% vs 19%, p = 0.003), abnormal discharge from the incision (serous: 8.6% vs 10.5%, purulent: 2.9% vs 16.7%, p < 0.001), incision separation (1% vs 7.1%, p = 0.001), and cellulitis (4.8% vs 13.3%, p = 0.002). At week-2 follow-up, there were no patients in the intervention group with fever, abnormal discharge from the incision, incision separation, or cellulitis and there was a statistically significant difference for fever, abnormal discharge from the incision, and incision separation between the two groups (p < 0.001, p = 0.001, p = 0.014, respectively).
Post-operative administration of cephalexin and metronidazole for 48-h post-cesarean delivery among obese women, in addition to the standard pre-operative prophylaxis, reduced the overall rate of surgical site infection and wound infection symptoms in a 2-week follow-up. Trial registration The study protocol was approved by the Iranian Registry of Clinical Trials (IRCTID: IRCT20200608047685N2) on 2021-03-15.
剖宫产术（CS）是美国最常进行的手术。与阴道分娩相比，CS 具有更高的母婴死亡率、发病率和并发症风险，其中手术部位感染（SSI）最为常见。我们旨在评估肥胖妇女 CS 后口服头孢氨苄和甲硝唑对 SSI 的有效性。
我们进行了一项随机、双盲临床试验，比较了肥胖妇女 CS 后口服头孢氨苄和甲硝唑与头孢氨苄和安慰剂对 SSI 的预防作用。这些妇女在接受术前预防性头孢菌素抗生素治疗后接受了研究。该研究于 2019 年 4 月至 2020 年 2 月在马什哈德医科大学 Ommolbanin 医院进行。
参与者被随机分为干预组（n=210）和对照组（n=210）。在第 1 周随访时，与对照组相比，干预组的结果在发热（9%比 19%，p=0.003）、切口异常排出（浆液性：8.6%比 10.5%，脓性：2.9%比 16.7%，p<0.001）、切口分离（1%比 7.1%，p=0.001）和蜂窝织炎（4.8%比 13.3%，p=0.002）方面明显较低。在第 2 周随访时，干预组没有发热、切口异常排出、切口分离或蜂窝织炎的患者，两组之间的发热、切口异常排出和切口分离有统计学显著差异（p<0.001，p=0.001，p=0.014）。
肥胖妇女 CS 后口服头孢氨苄和甲硝唑 48 小时，除了标准的术前预防外，还降低了 2 周随访时手术部位感染和伤口感染症状的总体发生率。试验注册 该研究方案于 2021 年 3 月 15 日获得伊朗临床试验注册中心（IRCTID：IRCT20200608047685N2）的批准。
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