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

Dow University of Health Sciences

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Emergency Laparotomies; Seroma; Surgical Wound; Surgical Site Infection; Laparotomies; Post Operative Wound Infection; Surgical Incision; Wound Infection

Treatments: Procedure: Povidone-iodine Swab; Procedure: 0.9% saline solution

Study type: Interventional

Funder types: Other

Identifiers

NCT05989386

2811

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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200 participants in 2 patient groups

Group A

Experimental group

Description:

Intra-operative wound irrigation of 0.9% solution saline solution

Treatment:

Procedure: 0.9% saline solution

Group B

Active Comparator group

Description:

No intra-operative wound lavage done

Treatment:

Procedure: Povidone-iodine Swab