Department of Surgery, The University of Texas Southwestern Medical Center, Dallas, Texas, USA.
American College of Surgeons, Chicago, Illinois, USA.
BMJ Open. 2021 Mar 4;11(3):e048398. doi: 10.1136/bmjopen-2020-048398.
Although antibiotic prophylaxis is established in reducing postoperative surgical site infections (SSIs), the optimal antibiotic for prophylaxis in pancreatoduodenectomy (PD) remains unclear. The study objective is to evaluate if administration of piperacillin-tazobactam as antibiotic prophylaxis results in decreased 30-day SSI rate compared with cefoxitin in patients undergoing elective PD.
This study will be a multi-institution, double-arm, non-blinded randomised controlled superiority trial. Adults ≥18 years consented to undergo PD for all indications who present to institutions participating in the National Surgical Quality Improvement Program Hepato-Pancreato-Biliary (NSQIP HPB) Collaborative will be included. Data collection will use the NSQIP HPB Collaborative Surgical Clinical Reviewers. Patients will be randomised to either 1-2 g intravenous cefoxitin or 3.375-4.5 g intravenous piperacillin-tazobactam within 60 min of surgical incision. The primary outcome will be 30-day postoperative SSI rate following PD. Secondary outcomes will include 30-day postoperative mortality; specific postoperative complication rate; and unplanned reoperation, length of stay, and hospital readmission. A subset of patients will have bacterial isolates and sensitivities of intraoperative bile cultures and SSIs. Postoperative SSIs and secondary outcomes will be analysed using logistic regression models with the primary predictor as the randomised treatment group. Additional adjustment will be made for preoperative biliary stent presence. Additionally, bacterial cultures and isolates will be summarised by presence of bacterial species and antibiotic sensitivities.
This study is approved by the Institutional Review Board at Memorial Sloan Kettering Cancer Center. This trial will evaluate the effect of piperacillin-tazobactam compared with cefoxitin as antibiotic prophylaxis on the hazard of postoperative SSIs. The results will be disseminated regardless of the effect of the intervention on study outcomes. The manuscript describing the effect of the intervention will be submitted to a peer-reviewed journal when data collection and analyses are complete.
NCT03269994.
虽然抗生素预防已被证实可降低术后手术部位感染（SSI）的发生率，但在胰十二指肠切除术（PD）中，用于预防的最佳抗生素仍不明确。本研究旨在评估哌拉西林-他唑巴坦作为抗生素预防用药与头孢西丁相比，是否能降低接受择期 PD 的患者 30 天 SSI 发生率。
这将是一项多机构、双臂、非盲随机对照优效性试验。同意接受 PD 治疗的所有适应证且年龄≥18 岁的成年患者，以及参与国家外科质量改进计划肝胆胰（NSQIP HPB）协作的机构患者，将被纳入本研究。数据收集将使用 NSQIP HPB 协作外科临床审查员。患者将被随机分为 1-2 g 静脉注射头孢西丁或 3.375-4.5 g 静脉注射哌拉西林-他唑巴坦，在手术切口 60 分钟内给药。主要结局为 PD 后 30 天术后 SSI 发生率。次要结局包括 30 天术后死亡率；特定术后并发症发生率；以及计划外再次手术、住院时间和医院再入院。将对一部分患者进行术中胆汁培养和 SSI 的细菌分离和药敏分析。将使用逻辑回归模型分析术后 SSI 和次要结局，主要预测因素为随机治疗组。将根据术前是否存在胆道支架进行额外调整。此外，将根据细菌种类和抗生素敏感性总结细菌培养和分离物。
本研究已获得纪念斯隆凯特琳癌症中心机构审查委员会的批准。本试验将评估与头孢西丁相比，哌拉西林-他唑巴坦作为抗生素预防用药对术后 SSI 风险的影响。无论干预措施对研究结果的影响如何，结果都将予以公布。当数据收集和分析完成后，将向同行评议期刊提交描述干预效果的手稿。
NCT03269994。
