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

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

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.

Study Overview

• Status: Completed
• Conditions: Diabete Mellitus; Surgical Site Infection; Abdominal Hysterectomy
• Intervention / Treatment: Device: Irrigation and suction through subcutaneus drains

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 Type: Interventional
• Enrollment (Actual): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab
    • Lahore, Punjab, Pakistan, 042
      • Lady Willingdon Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 37 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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.

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

Collaborators and Investigators

• Sponsor: King Edward Medical University
• Investigators: Study Director: Mohammmad Khalid, MBBS,MHM, Pakistan Institute of Cardiology

Publications and helpful links

General Publications

• Flow Investigators. Fluid lavage of open wounds (FLOW): design and rationale for a large, multicenter collaborative 2 x 3 factorial trial of irrigating pressures and solutions in patients with open fractures. BMC Musculoskelet Disord. 2010 May 6;11:85. doi: 10.1186/1471-2474-11-85.
• Hasan MY, Teo R, Nather A. Negative-pressure wound therapy for management of diabetic foot wounds: a review of the mechanism of action, clinical applications, and recent developments. Diabet Foot Ankle. 2015 Jul 1;6:27618. doi: 10.3402/dfa.v6.27618. eCollection 2015.
• Ivanzov S, Soynov I, Kulyabin Y, Zubritskiy A, Voitov A, Omelchenko A, Arkhipov A, Bogachev-Prokophiev A. Vacuum-assisted closure versus closed irrigation for deep sternal wound infection treatment in infants: a propensity score-matched study. Interact Cardiovasc Thorac Surg. 2019 Nov 1;29(5):776-782. doi: 10.1093/icvts/ivz167.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2017
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): March 31, 2022

Study Registration Dates

• First Submitted: October 29, 2022
• First Submitted That Met QC Criteria: November 3, 2022
• First Posted (Actual): November 10, 2022

Study Record Updates

• Last Update Posted (Actual): November 15, 2022
• Last Update Submitted That Met QC Criteria: November 10, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: pain; Wound healing; Hysterectomy; suction,
• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Postoperative Complications; Endocrine System Diseases; Wound Infection; Diabetes Mellitus; Infections; Surgical Wound Infection
• Other Study ID Numbers: 215/RC/KEMU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: The IPD will be shared after publication of the study.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No