Incidence of surgical site infection rates with intraoperative antibiotic prophylaxis vs long duration post operative prophylactic antibiotic therapy in luminal gastrointestinal surgeries : a non inferiority randomized control trial
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- To assess incidence of surgical site infections in patients receiving intraoperative prophylactic antibiotic dose alone v/s continued post-operative antibiotic prophylaxis
研究概览
简要总结
This study is to assess incidence of surgical site infections in patients receiving intraoperative prophylactic antibiotic dose alone v/s continued post-operative antibiotic prophylaxis and to compare the post-operative length of stay and 30-day perioperative morbidity and mortality associated with SSI in the two groups.
The purpose of this study is to assess the need for post operative antibiotic prophylaxis and the associated SSI rates and morbidities and mortality associated in the two groups in class 2 GI luminal study . It has been seen that antibiotics are not required in class 1 wounds
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients willing to give consent to be a participant in this study Patients with at least one month of follow up Patients undergoing luminal gastrointestinal surgeries in elective settings (open and laparoscopic) Patients undergoing surgeries of stomach, small bowel and large bowel(colonic) Patients with class 2 wounds.
排除标准
- •Patients not consenting to participate in study Patients who have undergone oesophageal surgeries Patients requiring ICU admission during post-operative period Patients who have received blood transfusions during intra-operative period Patients who develop organ failure (requiring mechanical ventilation, requiring pressure support) Patients with an open abdomen (intra -op bogota application) Patients who were operated outside Patients who are lost to follow up, leaving against medical advice or patients who have absconded.
结局指标
主要结局
To assess incidence of surgical site infections in patients receiving intraoperative prophylactic antibiotic dose alone v/s continued post-operative antibiotic prophylaxis
时间窗: 30 days
次要结局
- To compare the post-operative length of stay.(30-day perioperative morbidity and mortality associated with SSI in the two groups.)
研究者
Rishika Dhekial Pyrbot
Postgraduate Institute of Medical Education and Research , Chandigarh