24 Versus 48 Hours of First Generation or Second Generation Cephalosporin as Prophylaxis to Reduce Surgical Site Infection in Adult Cardiac Surgery Patients: a Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 568
- 试验地点
- 1
- 主要终点
- surgical site infection rate is less with 48 hours rather than 24 hours
研究概览
简要总结
A randomized control trial studying the effect of prophylactic antibiotics to reduce surgical site infections following cardiac surgery in adults using 1st generation cephalosporin (Cefazolin) or 2nd generation cephalosporin (Cefuroxime).
详细描述
A prospective randomized controlled patient blinded study with 2x2 factional design. It aims to study optimal duration of antibiotic to reduce surgical site infections following cardiac surgery in adults 24 or 48 hours using 1st generation cephalosporin (Cefazolin) or 2nd generation cephalosporin (Cefuroxime). Patients shall remain on either medicines for 24 or 48 hours. The primary endpoints of the study are:(1) 48 hours antibiotic prophylaxis is superior to 24 hours in adult cardiac surgery (2) Cefuroxime is superior to Cafazolin as a prophylactic antibiotic in adult cardiac surgery. Secondary endpoints include; organisms causing surgical site infections, length of hospital and ICU stay, and worsening in renal function.
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
- •Ability to provide informed consent
- •Planned to undergo a cardiac surgical procedure
排除标准
- •Patients on antibiotics on the day of surgery or those who received any within 7 days for any reason
- •Patients taken to operating room as salvage
- •Patients who are allergic to either cefuroxime or cefazolin
- •Patients for LVAD or ECMO
- •Patients who are known MRSA carriers
- •Patients receiving steroid therapy
研究组 & 干预措施
24 hour Cefuroxime arm
25% of the entire study participants are assigned to 24 hours and second generation cephalosporin
干预措施: 24 hours (Other)
24 hour Cefuroxime arm
25% of the entire study participants are assigned to 24 hours and second generation cephalosporin
干预措施: Cefuroxime (Drug)
24 hour Cefazolin arm
25% of the entire study participants are assigned to 24 hours and first generation cephalosporin
干预措施: Cefazolin (Drug)
24 hour Cefazolin arm
25% of the entire study participants are assigned to 24 hours and first generation cephalosporin
干预措施: 24 hours (Other)
48 hour Cefuroxime arm
25% of the entire study participants are assigned to 48 hours and second generation cephalosporin
干预措施: Cefuroxime (Drug)
48 hour Cefuroxime arm
25% of the entire study participants are assigned to 48 hours and second generation cephalosporin
干预措施: 48 hours (Other)
48 hour Cefazolin arm
25% of the entire study participants are assigned to 48 hours and first generation cephalosporin
干预措施: Cefazolin (Drug)
48 hour Cefazolin arm
25% of the entire study participants are assigned to 48 hours and first generation cephalosporin
干预措施: 48 hours (Other)
结局指标
主要结局
surgical site infection rate is less with 48 hours rather than 24 hours
时间窗: within 3 months from date of surgery
That Longer duration of prophylaxis is better than shorter duration
surgical site infection rate is less with Cefuroxime than Cefazolin
时间窗: within 3 months from date of surgery
that Second Generation Cefalosporin is superior to first generation
次要结局
- Length of ICU Stay will be shorter in the group assigned to 48 hours of cefuroxime(within 3 months from date of surgery)
- Length of actual Hospital Stay in the group assigned to 48 hours of cefuroxime(within 3 months from date of surgery)
- rate of infection with a specific organism following each of the antibiotics used(within 3 months from date of surgery)
- change from baseline of serum creatinine for each antibiotic used(within 3 months from date of surgery)