Assessing the impact of Intraoperative wound irrigation (IOWI) with Normal saline on incisional surgical site infections (SSI) in patients with laparotomy abdominal incisional wounds when compared to no irrigation: A two arm parallel randomized control trial at a tertiary care centre.
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 244
- 试验地点
- 1
- 主要终点
- Incidence of surgical site infection will be assessed in patients with abdominal laparotomy wound
研究概览
简要总结
All the patients undergoing Abdominal surgeries in the department of General Surgery, Obstetrics and gynaecology will be recruited in this study. After taking informed consent a detailed case proforma will be filled with relevant details and parameters as per study protocol. All patients will receive preop antibiotics as per the antibiotic policy of the hospital. All the patients will have their peritoneum closed as usual and before skin closure sequentially numbered opaque sealed envelope will be opened to reveal allocation, whether group A or group B
• In Group A, wound irrigation will be done with normal saline
• In Group B, wound will not be irrigated with normal saline
• Post surgery follow up will be monitored and recorded for SSI according to CDC guidelines
• The details of the participants will entered in the clear case record proforma
• The follow up will be done till POD-30
• In case of early discharge the patient will be seen in the OPD or if not mandatory on OPD when scheduled, they will be followed telephonically
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)(—)
- 性别
- All
入选标准
- •1.Patients aged 18 years and more
- •Abdominal wounds after rectus sheath closure.
排除标准
- •Relaparotomy wounds in the same hospital stay/admission
- •Abdominal/ laparotomy wound where delayed primary closure is done.
结局指标
主要结局
Incidence of surgical site infection will be assessed in patients with abdominal laparotomy wound
时间窗: Post operative day 1,2,3,4,5,30 and at the time of discharge and suture removal
次要结局
- 1. Length of hospital stay(2. Pain score using VAS)
研究者
Dr Moonmoon Kedia
AIIMS, Raipur
