Irrigation and Suction Trial to Prevent SSI

Study Overview
=================
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.

Official Title
-----------------
Laparotomy Wound Care With Irrigation and Negative Pressure Technique in High-risk Cases of Surgical Site Infection(SSI)-A Randomized Controlled Trial

Conditions
-----------------
Surgical Site Infection, Diabete Mellitus, Abdominal Hysterectomy

Intervention / Treatment
-----------------
* Device: Irrigation and suction through subcutaneus drains


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 41 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: I&S arm<br>The 150 participants of the experimental arm will be assigned to the I&S group and they will be inserted bilateral Nelton drains of 24 sizes in the subcutaneous space after the closure of the rectus sheath. Their wound will be irrigated with 500cc Normal saline at running speed followed by suction for a full day. The procedure will be repeated for three consecutive days. The drains will be removed on the fourth postoperative day. | Device: Irrigation and suction through subcutaneus drains<br>* 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.<br>|
| No Intervention: control<br>The 150 participants of the non-intervention group will be assigned to the control arm, The wound will be closed by interrupted mattress stitches without the insertion of subcutaneous drains. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SSI rate | number(proportion)of surgical site infections in Intervention and control group | first postoperative day to eighth postoperative day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| length of wound disruption | proportion of wound involved | 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 | at the time of diagnosis | 
| pain score during hospital stay | composit mean pain score from 0-10, 10 will be maximum adverse outcome | 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 | from discharge to completion of 12 postoperative weeks | 
| Other complications | complications of wound in I&S group and control group | from discharge to completion of 12 postoperative weeks | 
| patient satisfaction | not satisfied=0, satisfied=1,very satisfied=2,2 is best outcome | at12th postoperative weeks completion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
suction,, Wound healing, pain, Hysterectomy