NCT05989386 Outcomes of High-volume Saline Irrigation VS Povidone-Iodine Solution Cleaning of IOWI in Preventing SSIs in Emergency Laparotomies
| NCT ID | NCT05989386 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Dow University of Health Sciences |
| Condition | Surgical Site Infection |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2023-04-29 |
| Primary Completion | 2025-09-29 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 200 participants in total. It began in 2023-04-29 with a primary completion date of 2025-09-29.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Omer Bin Khalid, Assist Prof.
PRINCIPAL INVESTIGATOR
Dr. Ruth F. M. Pfau Civil Hospital Karachi
Frequently Asked Questions
Who can join the NCT05989386 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 60 Years, studying Surgical Site Infection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05989386 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05989386 currently recruiting?
Yes, NCT05989386 is actively recruiting participants. Contact the research team at dromerkhalid@gmail.com for enrollment information.
Where is the NCT05989386 trial being conducted?
This trial is being conducted at Karachi, Pakistan.
Who is sponsoring the NCT05989386 clinical trial?
NCT05989386 is sponsored by Dow University of Health Sciences. The principal investigator is Omer Bin Khalid, Assist Prof. at Dr. Ruth F. M. Pfau Civil Hospital Karachi. The trial plans to enroll 200 participants.