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

Surgical Site Infection Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05989386
• Other study ID #: 2811
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: April 29, 2023
• Est. completion date: May 29, 2024

Study information

• Verified date: August 2023
• Source: Dow University of Health Sciences
• Contact: Omer Bin Khalid, Assist Prof.
• Phone: +92 321 2040064
• Email: dromerkhalid[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: May 29, 2024
• Est. primary completion date: April 29, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Emergencies
• Infections
• Post Operative Wound Infection
• Seroma
• Surgical Incision
• Surgical Site Infection
• Surgical Wound
• Surgical Wound Infection
• Wound Infection
• Wounds and Injuries

Intervention

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.
• Povidone-iodine Swab
No intra-operative wound lavage done, and wound would be cleaned with povidone doused swab.

Locations

Country	Name	City	State
Pakistan	Dr. Ruth K. M. Pfau Civil Hospital Karachi	Karachi	Sindh

Sponsors (1)

Lead Sponsor	Collaborator
Dow University of Health Sciences

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Superficial Surgical site infections	Development of Superficial Surgical Site Infection as determined by the CDC guidelines.	Upto 4 weeks post-operatively
Secondary	Length of Hospital Stay	Number of in-hospital days (from time of admission to time of discharge)	Upto 4 weeks post-operatively