Irrigation and Suction Trial to Prevent SSI
- Conditions
- Diabete MellitusSurgical Site InfectionAbdominal Hysterectomy
- Registration Number
- NCT05611944
- Lead Sponsor
- King Edward Medical University
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 300
- 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.
- a BMI of less than 25kg/m2
- a preoperative haemoglobin level of less than 10 g/dl.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method SSI rate first postoperative day to eighth postoperative day number(proportion)of surgical site infections in Intervention and control group
- Secondary Outcome Measures
Name Time Method length of wound disruption at the time of diagnosis proportion of wound involved
Depth of wound disruption at the time of diagnosis involving skin margins=1,subctaneous tissue=2,rectus sheath=3,peritoneum=4, 4 is the worst outcome
pain score after discharge from discharge to completion of 12 postoperative weeks composite mean pain scorefrom 0-10, 10 will be maximum adverse outcome on week4, week8, week12
Other complications from discharge to completion of 12 postoperative weeks complications of wound in I\&S group and control group
pain score during hospital stay from first postoperative day to eightth postoperative day composit mean pain score from 0-10, 10 will be maximum adverse outcome
patient satisfaction at12th postoperative weeks completion not satisfied=0, satisfied=1,very satisfied=2,2 is best outcome
Trial Locations
- Locations (1)
Lady Willingdon Hospital
🇵🇰Lahore, Punjab, Pakistan
Lady Willingdon Hospital🇵🇰Lahore, Punjab, Pakistan