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

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

Status
Recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05989386
Enrollment
200
Registered
2023-08-14
Start date
2023-04-29
Completion date
2025-12-29
Last updated
2025-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief 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.

Interventions

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.

PROCEDUREPovidone-iodine Swab

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

Sponsors

Dow University of Health Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Incidence of Superficial Surgical site infectionsUpto 4 weeks post-operativelyDevelopment of Superficial Surgical Site Infection as determined by the CDC guidelines.

Secondary

MeasureTime frameDescription
Length of Hospital StayUpto 4 weeks post-operativelyNumber of in-hospital days (from time of admission to time of discharge)

Countries

Pakistan

Contacts

Primary ContactOmer Bin Khalid, Assist Prof.
dromerkhalid@gmail.com+92 321 2040064
Backup ContactAfeera Ahmed, Undergraduate
afeeranws@gmail.com+923352547330

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026