Abdominal Hysterectomy, Diabete Mellitus, Surgical Site Infection
Conditions
Keywords
suction,, Wound healing, pain, Hysterectomy
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.
Interventions
DEVICEIrrigation and suction through subcutaneus drains
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.
Sponsors
King Edward Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Intervention model description
The participants will be randomized by the random number container method into an equal number of I&S groups and control groups through the parallel assignment.
Eligibility
Sex/Gender
FEMALE
Age
41 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* a BMI of less than 25kg/m2 * a preoperative haemoglobin level of less than 10 g/dl.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| SSI rate | first postoperative day to eighth postoperative day | number(proportion)of surgical site infections in Intervention and control group |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 during hospital stay | from first postoperative day to eightth postoperative day | composit mean pain score from 0-10, 10 will be maximum adverse outcome |
| length of wound disruption | at the time of diagnosis | proportion of wound involved |
| Other complications | from discharge to completion of 12 postoperative weeks | complications of wound in I&S group and control group |
| patient satisfaction | at12th postoperative weeks completion | not satisfied=0, satisfied=1,very satisfied=2,2 is best 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 |
Countries
Pakistan
Outcome results
None listed