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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Surgical Site Infection, Surgical Wound, Surgical Incision, Emergency Laparotomies, Laparotomies, Post Operative Wound Infection, Wound Infection, Seroma

Intervention / Treatment
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* Procedure: 0.9% saline solution
* Procedure: Povidone-iodine Swab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>Intra-operative wound irrigation of 0.9% solution saline solution | Procedure: 0.9% saline solution<br>* 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.<br>|
| Active Comparator: Group B<br>No intra-operative wound lavage done | Procedure: Povidone-iodine Swab<br>* No intra-operative wound lavage done, and wound would be cleaned with povidone doused swab.<br>* Other names: Control;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Superficial Surgical site infections | Development of Superficial Surgical Site Infection as determined by the CDC guidelines. | Upto 4 weeks post-operatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of Hospital Stay | Number of in-hospital days (from time of admission to time of discharge) | Upto 4 weeks post-operatively |