Outcomes of High-volume Saline Irrigation VS Povidone-Iodine Solution Cleaning of IOWI in Preventing SSIs in Emergency Laparotomies

Outcomes of High-volume Saline Irrigation VS Povidone-Iodine Solution Cleaning of Intraoperative Incision Wound in Preventing Surgical Site Infections in Emergency Laparotomies: A Randomized Controlled Trial

The goal of this clinical trial is to compare the outcomes of High-volume saline irrigation vs Povidone-iodine solution cleaning of the intraoperative incision wound in preventing superficial surgical site infections in patients undergoing emergency laparotomies. The main question it aims to answer are:

• Incidence of SSI after intervention
• Length of hospital stay

Participants will be randomly assigned to two groups receiving either of the two groups:

Group A: 1000ml of IOWI with saline solution prior to incision closure Group B: The incisional wound will be closed conventionally without irrigation.

Researchers will compare groups A( experimental group) and B (control group) to compare the incidence of superficial surgical site infections after intervention.

Study Overview

• Status: Recruiting
• Conditions: Surgical Wound; Surgical Site Infection; Wound Infection; Surgical Incision; Seroma; Post Operative Wound Infection; Emergency Laparotomies; Laparotomies
• Intervention / Treatment: Procedure: 0.9% saline solution; Procedure: Povidone-iodine Swab

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Omer Bin Khalid, Assist Prof.; Phone Number: +92 321 2040064; Email: dromerkhalid@gmail.com
• Study Contact Backup: Name: Afeera Ahmed, Undergraduate; Phone Number: +923352547330; Email: afeeranws@gmail.com

Study Locations

• Pakistan
  • Sindh
    • Karachi, Sindh, Pakistan, 74400
      • Recruiting
      • Dr. Ruth K. M. Pfau Civil Hospital Karachi
      • Contact: Omer Bin khalid, Asst. Prof; Phone Number: +92 321 2040064; Email: dromerkhalid@gmail.com
      • Principal Investigator: Omer Bin Khalid, FCPS-II
      • Sub-Investigator: Afeera Bashir, Undergrad.
      • Sub-Investigator: Azzam Ali, Undergrad.
      • Sub-Investigator: Bushra Saeed Khan, FCPS-I
      • Sub-Investigator: Rabbiyya Ali, FCPS-II
      • Sub-Investigator: Imrana Zulfikar, FCPS-II

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• • Patients undergoing emergency laparotomy under the care of surgical-6 unit of Dr. Ruth K. M. Pfau Civil Hospital Karachi

  • The age of patients should be between 18-60 years old.

Exclusion Criteria:

• Diabetic patients
• Immune-suppressed patients
• Patients taking steroids
• Patients undergoing chemo-radiotherapy.
• Pregnant females
• Previous abdominal surgery within the last 30 days.
• Presence of concurrent abdominal wall infections.
• Trauma Laparotomies
• Large Bowel perforations

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A; Intra-operative wound irrigation of 0.9% solution saline solution	Procedure: 0.9% saline solution; During emergency laparotomy, after the primary surgical procedure. the sheath will be sutured and the incision site will then be irrigated with three rounds of 1 liter of 0.9% saline solution, which will be completely aspirated before the closure of the incisional wound in experimental group.
Active Comparator: Group B; No intra-operative wound lavage done	Procedure: Povidone-iodine Swab; No intra-operative wound lavage done, and wound would be cleaned with povidone doused swab.; Other Names: Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Superficial Surgical site infections	Development of Superficial Surgical Site Infection as determined by the CDC guidelines.	Upto 4 weeks post-operatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of Hospital Stay	Number of in-hospital days (from time of admission to time of discharge)	Upto 4 weeks post-operatively

Collaborators and Investigators

• Sponsor: Dow University of Health Sciences
• Investigators: Principal Investigator: Omer Bin Khalid, Assist Prof., Dr. Ruth F. M. Pfau Civil Hospital Karachi; Study Director: Imrana Zulfikar, Professor, Dr. Ruth F. M. Pfau Civil Hospital Karachi

Study record dates

Study Major Dates

• Study Start (Actual): April 29, 2023
• Primary Completion (Estimated): September 29, 2025
• Study Completion (Estimated): December 29, 2025

Study Registration Dates

• First Submitted: July 19, 2023
• First Submitted That Met QC Criteria: August 9, 2023
• First Posted (Actual): August 14, 2023

Study Record Updates

• Last Update Posted (Actual): June 18, 2025
• Last Update Submitted That Met QC Criteria: June 14, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Postoperative Complications; Pathologic Processes; Disease Attributes; Surgical Wound; Emergencies; Wounds and Injuries; Infections; Communicable Diseases; Surgical Wound Infection; Wound Infection; Anti-Infective Agents; Anti-Infective Agents, Local; Plasma Substitutes; Blood Substitutes; Povidone; Povidone-Iodine
• Other Study ID Numbers: 2811

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No