A Phase III Multicenter, Open Label Randomized Controlled Trial of Cefoxitin Versus Piperacillin-Tazobactam as Surgical Antibiotic Prophylaxis in Patients Undergoing Pancreatoduodenectomy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 967
- 试验地点
- 32
- 主要终点
- Number of Participants Evaluated for the Effectiveness of Cefoxitin as a Surgical Antibiotic Prophylaxis.
研究概览
简要总结
The purpose of this study is to figure out which commonly used antibiotic, cefoxitin or piperacillin-tazobactam, is better at decreasing the rate of surgical site infections after pancreatoduodenectomy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >/= 18 years
- •Patients undergoing elective pancreatoduodenectomy (PD) for any diagnosis/indication
排除标准
- •Patients undergoing a minimally invasive PD, such as laparoscopic or robotic PD
- •Patients with known and documented allergies to any of the penicillins, cephalosporins, or β-lactamase inhibitors
- •Patients who are otherwise ineligible to receive the antibiotics in this study
- •Patients highly unlikely to undergo PD according to the surgeon's judgment, such as conditions amenable to pancreas enucleation, ampullectomy, etc.
- •Patients with long-term glucocorticosteroid use. The following uses of corticosteroids are permitted: single doses, topical applications (e.g., for rash), inhaled sprays (e.g., for obstructive airways diseases), eye drops or local injections (e.g., intra-articular)
- •Patients unable to provide informed consent
- •Creatinine clearance (CrCl) </= 40 mL/min
- •Patients receiving hemodialysis or peritoneal dialysis
- •Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test
- •Patients with a known bacterial infection present at the time of surgery or who received antimicrobial therapy within 7 days prior to surgery
研究组 & 干预措施
Cefoxitin
干预措施: Cefoxitin (Drug)
Piperacillin-tazobactam
干预措施: Piperacillin-tazobactam (Drug)
结局指标
主要结局
Number of Participants Evaluated for the Effectiveness of Cefoxitin as a Surgical Antibiotic Prophylaxis.
时间窗: 30 days
To compare the effectiveness of cefoxitin, a second generation cephalosporin (Cohort 1), with piperacillin-tazobactam, a broad-spectrum penicillin (Cohort 2), as surgical antibiotic prophylaxis in decreasing the overall rate of postoperative SSIs in patients undergoing PD. The primary endpoint, overall SSI rate, is defined as superficial incisional SSI, deep incisional SSI, or organ/space SSI within the first 30 days after the operation, as defined according to the ACS NSQIP data collection operations manual.
次要结局
未报告次要终点