Outcomes of High-volume Saline Irrigation VS Povidone-Iodine Solution Cleaning of IOWI in Preventing SSIs in Emergency Laparotomies
NCT05989386 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 200
Last updated 2025-06-18
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.
Conditions
- Surgical Site Infection
- Surgical Wound
- Surgical Incision
- Emergency Laparotomies
- Laparotomies
- Post Operative Wound Infection
- Wound Infection
- Seroma
Interventions
- 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.
- PROCEDURE
-
Povidone-iodine Swab
No intra-operative wound lavage done, and wound would be cleaned with povidone doused swab.
Sponsors & Collaborators
-
Dow University of Health Sciences
lead OTHER
Principal Investigators
-
Omer Bin Khalid, Assist Prof. · Dr. Ruth F. M. Pfau Civil Hospital Karachi
-
Imrana Zulfikar, Professor · Dr. Ruth F. M. Pfau Civil Hospital Karachi
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-04-29
- Primary Completion
- 2025-09-29
- Completion
- 2025-12-29
Countries
- Pakistan
Study Locations
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