Role of intraoperative incision irrigation with super-oxidized solution in reducing surgical site infection.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- DHR
- 入组人数
- 180
- 试验地点
- 1
研究概览
简要总结
Surgical site infections are among the most common complications after abdominal surgery, especially in emergency laparotomy where rates can reach up to 40 percent. These infections increase morbidity, prolong hospital stay, raise readmission rates and healthcare costs. Although several preventive strategies exist, the role of super oxidized solution for intraoperative incision irrigation remains unclear.
This prospective randomized study will include 180 adult patients undergoing emergency exploratory laparotomy for contaminated or dirty abdominal wounds. Patients will be randomly allocated into two groups of 90 each. Group A will receive incision wound irrigation with 100 to 300 ml of super oxidized solution before closure. Group B will receive 1000 to 1500 ml of normal saline irrigation before closure. All other perioperative management including antibiotics, skin preparation, suturing technique and postoperative care will be standardized.
The primary outcome will be 30 day surgical site infection based on CDC criteria. Secondary outcomes will include wound dehiscence, hematoma, seroma, duration of antibiotic use, readmission, reoperation and length of hospital stay. Statistical analysis will be performed using intention to treat principles with appropriate comparative tests and multivariate logistic regression.
The study is novel because evidence on super oxidized solution for intraoperative incision irrigation is limited. It aims to determine whether its use can significantly reduce surgical site infections in emergency laparotomy patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Double
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)(—)
- 性别
- All
入选标准
- •for both irrigation and control groups are identical: Patients with age more than or equal to 18 years to 70 years old undergoing laparotomy for abdominal pathology causing contaminated or dirty wounds will be included.
排除标准
- •Laparoscopic operations, trauma patients and patient with pregnancy.
研究者
Karamjot Singh Sandhu
GMC and Rajindra Hospital, Patiala,Punjab
