Outcomes of High-volume Saline Irrigation VS Povidone-Iodine Solution Cleaning of IOWI in Preventing SSIs in Emergency Laparotomies
NCT ID: NCT05989386
Last Updated: 2025-06-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2/PHASE3
200 participants
INTERVENTIONAL
2023-04-29
2025-12-29
Brief Summary
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* 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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Group A
Intra-operative wound irrigation of 0.9% solution saline solution
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.
Group B
No intra-operative wound lavage done
Povidone-iodine Swab
No intra-operative wound lavage done, and wound would be cleaned with povidone doused swab.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* The age of patients should be between 18-60 years old.
Exclusion Criteria
* 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
18 Years
60 Years
ALL
No
Sponsors
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Dow University of Health Sciences
OTHER
Responsible Party
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Omer bin khalid
Principal Investigator (Assistant Professor)
Principal Investigators
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Omer Bin Khalid, Assist Prof.
Role: PRINCIPAL_INVESTIGATOR
Dr. Ruth F. M. Pfau Civil Hospital Karachi
Imrana Zulfikar, Professor
Role: STUDY_DIRECTOR
Dr. Ruth F. M. Pfau Civil Hospital Karachi
Locations
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Dr. Ruth K. M. Pfau Civil Hospital Karachi
Karachi, Sindh, Pakistan
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2811
Identifier Type: -
Identifier Source: org_study_id
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