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

Sponsor

Dow University of Health Sciences (Other)

Overall Status

Recruiting

CT.gov ID

NCT05989386

Collaborator

(none)

200

Enrollment

Location

Arms

Anticipated Duration (Months)

15.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Surgical Site Infection Surgical Wound Surgical Incision Emergency Laparotomies Laparotomies Post Operative Wound Infection Wound Infection Seroma	Procedure: 0.9% saline solution Procedure: Povidone-iodine Swab	Phase 2/Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Apr 29, 2023

Anticipated Primary Completion Date :

Apr 29, 2024

Anticipated Study Completion Date :

May 29, 2024

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dr. Ruth K. M. Pfau Civil Hospital Karachi	Karachi	Sindh	Pakistan	74400

Sponsors and Collaborators

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