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NCT Number: NCT05611944

Irrigation and Suction Trial to Prevent SSI

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.

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Key information

Conditions

Surgical Site Infection Abdominal Hysterectomy Diabete Mellitus Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Infections Metabolic Diseases Neurologic Manifestations Nutritional and Metabolic Diseases Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Surgical Wound Infection Wound Infection

Age range

41 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Lady Willingdon Hospital

Lahore, Punjab Province, 042, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Irrigation and suction through subcutaneus drains

Device

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.

Primary outcomes

  1. SSI rate

    Time frame: first postoperative day to eighth postoperative day

    number(proportion)of surgical site infections in Intervention and control group

Secondary outcomes

  1. length of wound disruption

    Time frame: at the time of diagnosis

    proportion of wound involved

  2. Depth of wound disruption

    Time frame: at the time of diagnosis

    involving skin margins=1,subctaneous tissue=2,rectus sheath=3,peritoneum=4, 4 is the worst outcome

  3. pain score during hospital stay

    Time frame: from first postoperative day to eightth postoperative day

    composit mean pain score from 0-10, 10 will be maximum adverse outcome

  4. pain score after discharge

    Time frame: from discharge to completion of 12 postoperative weeks

    composite mean pain scorefrom 0-10, 10 will be maximum adverse outcome on week4, week8, week12

  5. Other complications

    Time frame: from discharge to completion of 12 postoperative weeks

    complications of wound in I&S group and control group

  6. patient satisfaction

    Time frame: at12th postoperative weeks completion

    not satisfied=0, satisfied=1,very satisfied=2,2 is best outcome

Sponsors and collaborators

Lead sponsor

King Edward Medical University

Other

Registry information

Official study title

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

Acronym: I&S

Important dates

Study start
2017
Primary completion
2021
Study completion
2022
First posted
Nov 10, 2022
Registry last updated
Nov 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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