Laparotomy Wound Care With Irrigation and Negative Pressure Technique in High-risk Cases of Surgical Site Infection(SSI)-A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- SSI rate
研究概览
简要总结
The study will be conducted on women with risk factors for SSI assigned to gynecological surgery with an open abdominal approach. The participants will be designated to either Irrigation and suction arm by bilateral drain insertion or the control arm by randomization through the parallel assignment. The participants will be followed for the outcome for four days in the hospital and then at 4 weeks, 8 weeks and 12 weeks postoperatively. The primary outcome measure will be the SSI rate. Secondary outcomes will be signs of SSI, post-operative pain, other complications and patient satisfaction.
详细描述
This study will be carried out in Lady willingdon Hospital, Lahore. In this study, we will recruit middle-aged and elderly diabetic women who have been assigned to open abdominal hysterectomy due to different gynaecological reasons. This cohort is at great risk of surgical site infection and other risk factors of SSI like hypertension, hepatitis and malignancy may coexist in these women. The study period will span to include three hundred participants as calculated according to sample size. The women will be divided into either an I&S group or a control group by a simple random number container method. The women in the I&S group will be inserted with bilateral drains during surgery in subcutaneous tissue after the closure of the rectus sheath and irrigated with saline followed by suction through syringe suction attached to the wound for rest of the day. The procedure will continue for three days. On the fourth day, drains are removed and stitches are removed on the fourth postoperative day. In the control group, the wound will be closed by interrupted stitches without the insertion of subcutaneous drains. The dressing will be done daily for seven days. patients with no symptoms and signs of SS will be sent home on the eighth postoperative day. The patients will be followed for symptoms of SSI, pain, readmission rate, and other complications at 4,8 and 12 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
The groups will be masked to the Outcome assessor by assigning groups A and B instead of group names and the assessor will be kept blinded about which group is the I&S group.
入排标准
- 年龄范围
- 41 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Diabetic patients
- •age above 40years
- •BMI>25kg/m2
- •assigned to hysterectomy
- •fit for anaesthesia
- •patients with other medical disorders like hepatitis and hypertension will also be included in the study.
排除标准
- •a BMI of less than 25kg/m2
- •a preoperative haemoglobin level of less than 10 g/dl.
结局指标
主要结局
SSI rate
时间窗: first postoperative day to eighth postoperative day
number(proportion)of surgical site infections in Intervention and control group
次要结局
- length of wound disruption(at the time of diagnosis)
- Depth of wound disruption(at the time of diagnosis)
- pain score after discharge(from discharge to completion of 12 postoperative weeks)
- Other complications(from discharge to completion of 12 postoperative weeks)
- pain score during hospital stay(from first postoperative day to eightth postoperative day)
- patient satisfaction(at12th postoperative weeks completion)
研究者
Shazia Saaqib
Assistant Professor
King Edward Medical University