I&S: Irrigation and Suction Trial to Prevent SSI

Sponsor

King Edward Medical University (Other)

Overall Status

Completed

CT.gov ID

NCT05611944

Collaborator

(none)

300

Enrollment

Location

Arms

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Surgical Site Infection Diabete Mellitus Abdominal Hysterectomy	Device: Irrigation and suction through subcutaneus drains	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

300 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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.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 (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.

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Apr 1, 2017

Actual Primary Completion Date :

Dec 31, 2021

Actual Study Completion Date :

Mar 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: I&S arm 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 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.
No Intervention: control 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.

Arm

Intervention/Treatment

Experimental: I&S arm

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

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.

No Intervention: control

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.

Outcome Measures

Primary Outcome Measures

SSI rate [first postoperative day to eighth postoperative day]
number(proportion)of surgical site infections in Intervention and control group

Secondary Outcome Measures

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 during hospital stay [from first postoperative day to eightth postoperative day]
composit mean pain score from 0-10, 10 will be maximum adverse 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
patient satisfaction [at12th postoperative weeks completion]
not satisfied=0, satisfied=1,very satisfied=2,2 is best outcome

Eligibility Criteria

Criteria

Ages Eligible for Study:

41 Years to 80 Years

Sexes Eligible for Study:

Female

Accepts 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.