Impact of Antibiotic Prophylaxis Modification on Surgical Site Infections Following Pancreaticoduodenectomy: The Role of Local Microbiological Ecology (ICADI Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 117
- 试验地点
- 1
- 主要终点
- Surgical Site Infection rate within 30 days after pancreaticoduodenectomy
研究概览
简要总结
Patients undergoing pancreaticoduodenectomy after preoperative biliary drainage are at increased risk of surgical site infections (SSI) due to bile colonization. Recent guidelines recommend the use of piperacillin/tazobactam instead of cephalosporins for antibiotic prophylaxis in this population. However, the relevance of this strategy may depend on local microbiological ecology.
This monocentric ambispective cohort study aims to compare SSI rates between two periods: before and after implementation of piperacillin/tazobactam prophylaxis. The study also evaluates microbiological profiles of bile cultures, antibiotic susceptibility, and postoperative antibiotic exposure.
The primary hypothesis is that adaptation of antibiotic prophylaxis to local ecology may optimize outcomes while limiting unnecessary exposure to broad-spectrum antibiotics.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Other
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 (> 18 yrs)
- •Scheduled for pancreatic surgery
- •Presence of preoperative biliary stent
- •Postoperative admission to surgical ICU or intermediate care unit
排除标准
- •decline to participate
研究组 & 干预措施
Period 1 (2022 - 2023)
Adult patients scheduled for pancreatic surgery receiving cefazolin as antibiotic prophylaxis
Period 2 (2024 - 202()
Adult patients scheduled for pancreatic surgery receiving piperacillin/taazobactam as antibiotic prophylaxis
结局指标
主要结局
Surgical Site Infection rate within 30 days after pancreaticoduodenectomy
时间窗: Day 30
次要结局
- Pancreatic fistula rate within 30 days after pancreaticoduodenectomy(Day 30)
- Postoperative carbapenem exposure(Day 30)
- Proportion of bacteria susceptible to cephalosporins and piperacillin/tazobactam(Day 1)