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

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

PHASE2/PHASE3

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-29

Study Completion Date

2025-12-29

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.

Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Group A

Intra-operative wound irrigation of 0.9% solution saline solution

Group Type EXPERIMENTAL

0.9% saline solution

Intervention Type PROCEDURE

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

Group Type ACTIVE_COMPARATOR

Povidone-iodine Swab

Intervention Type PROCEDURE

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.

Intervention Type PROCEDURE

Povidone-iodine Swab

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

Intervention Type PROCEDURE

Other Intervention Names

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Control

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dow University of Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Omer bin khalid

Principal Investigator (Assistant Professor)

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status RECRUITING

Countries

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Pakistan

Central Contacts

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Omer Bin Khalid, Assist Prof.

Role: CONTACT

+92 321 2040064

Afeera Ahmed, Undergraduate

Role: CONTACT

+923352547330

Facility Contacts

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Omer Bin khalid, Asst. Prof

Role: primary

+92 321 2040064

Other Identifiers

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2811

Identifier Type: -

Identifier Source: org_study_id

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