Prophylactic Antibiotics in Preventing Surgical Site Infection After Hepatobiliary Surgery in High-Resistant Settings: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 378
- 试验地点
- 1
研究概览
简要总结
To analyse the efficacy of different preoperative prophylactic antimicrobial regimens for perioperative infection prevention in patients undergoing hepatobiliary surgery in a high antimicrobial resistance setting.
详细描述
Given the high incidence of postoperative surgical site infections (SSI) potentially attributable to bacterial antimicrobial resistance, the use of beta-lactam/beta-lactamase inhibitor combinations for prophylaxis may reduce SSI rates following hepatobiliary surgery in the current era of high antimicrobial resistance. To test this hypothesis, we propose a prospective pragmatic trial comparing piperacillin-tazobactam with the standard prophylactic regimen of cefuroxime for perioperative infection prevention in patients undergoing hepatobiliary surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Adult patients aged ≥18 years;
- •Deemed eligible for elective hepatobiliary surgery;
- •Demonstrated comprehension of the study nature and expressed willingness to comply with trial procedures;
- •Capable of providing written informed consent.
排除标准
- •History of β-lactam allergy or hypersensitivity
- •Uncontrolled preoperative infection;
- •Current or recent (within the preceding month) systemic corticosteroid administration;
- •Severe hepatic or renal impairment;
- •Pregnancy or lactation;
- •Concurrent enrolment in another clinical trial;
- •Any other condition deemed by the investigator to render the patient unsuitable for study participation.
研究者
Chen Dayu
Pharmacist in Charge
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School