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

Phase 2

Recruiting

• Conditions: Surgical Site Infection; Surgical Incision; Laparotomies; Post Operative Wound Infection; Seroma; Surgical Wound; Wound Infection; Emergency Laparotomies
• Interventions: Procedure: Povidone-iodine Swab; Procedure: 0.9% saline solution

• Registration Number: NCT05989386
• Lead Sponsor: Dow University of Health Sciences

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-04-29
• Study First Submitted: 2023-07-19
• Study First Submitted QC: 2023-08-09
• Study First Posted: 2023-08-14
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-11
• Last Update Posted: 2024-07-12
• Primary Completion: 2025-04-29
• Study Completion: 2025-05-29

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group B	Povidone-iodine Swab	No intra-operative wound lavage done
Group A	0.9% saline solution	Intra-operative wound irrigation of 0.9% solution saline solution

Primary Outcome Measures

Name	Time	Method
Incidence of Superficial Surgical site infections	Upto 4 weeks post-operatively	Development of Superficial Surgical Site Infection as determined by the CDC guidelines.

Secondary Outcome Measures

Name	Time	Method
Length of Hospital Stay	Upto 4 weeks post-operatively	Number of in-hospital days (from time of admission to time of discharge)

Trial Locations

Locations (1)

Dr. Ruth K. M. Pfau Civil Hospital Karachi; 🇵🇰 Karachi, Sindh, Pakistan