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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
300
Irrigation of wound will done by attaching 500cc saline to the drain on one side and let it flow freely from the other drain followed by suction of wound by attaching 60cc suction syringes on both sides creating suction pressure for 100 cc fluid.
Lady Willingdon Hospital
Lahore, Punjab Province, Pakistan
SSI rate
number(proportion)of surgical site infections in Intervention and control group
Time frame: first postoperative day to eighth postoperative day
length of wound disruption
proportion of wound involved
Time frame: at the time of diagnosis
Depth of wound disruption
involving skin margins=1,subctaneous tissue=2,rectus sheath=3,peritoneum=4, 4 is the worst outcome
Time frame: at the time of diagnosis
pain score during hospital stay
composit mean pain score from 0-10, 10 will be maximum adverse outcome
Time frame: from first postoperative day to eightth postoperative day
pain score after discharge
composite mean pain scorefrom 0-10, 10 will be maximum adverse outcome on week4, week8, week12
Time frame: from discharge to completion of 12 postoperative weeks
Other complications
complications of wound in I\&S group and control group
Time frame: from discharge to completion of 12 postoperative weeks
patient satisfaction
not satisfied=0, satisfied=1,very satisfied=2,2 is best outcome
Time frame: at12th postoperative weeks completion
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