Irrigation and Suction Trial to Prevent SSI (I&S)

King Edward Medical University

Status: Completed

Conditions: Surgical Site Infection; Diabete Mellitus; Abdominal Hysterectomy

Treatments: Device: Irrigation and suction through subcutaneus drains

Study type: Interventional

Funder types: Other

Identifiers

NCT05611944

215/RC/KEMU

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 patients

Sex: Female

Ages: 41 to 80 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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300 participants in 2 patient groups

I&S arm

Experimental group

Description:

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.

Treatment:

Device: Irrigation and suction through subcutaneus drains

control

No Intervention group

Description:

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.