NCT05989386

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Apr 2023

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 29, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 19, 2023

Completed
26 days until next milestone

First Posted

Study publicly available on registry

August 14, 2023

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 29, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 29, 2025

Completed
Last Updated

June 18, 2025

Status Verified

June 1, 2025

Enrollment Period

2.4 years

First QC Date

July 19, 2023

Last Update Submit

June 14, 2025

Conditions

Surgical Site InfectionSurgical WoundSurgical IncisionEmergency LaparotomiesLaparotomiesPost Operative Wound InfectionWound InfectionSeroma

Outcome Measures

Primary Outcomes (1)

  • Incidence of Superficial Surgical site infections

    Development of Superficial Surgical Site Infection as determined by the CDC guidelines.

    Upto 4 weeks post-operatively

Secondary Outcomes (1)

  • Length of Hospital Stay

    Upto 4 weeks post-operatively

Study Arms (2)

Group A

EXPERIMENTAL

Intra-operative wound irrigation of 0.9% solution saline solution

Procedure: 0.9% saline solution

Group B

ACTIVE COMPARATOR

No intra-operative wound lavage done

Procedure: Povidone-iodine Swab

Interventions

0.9% saline solutionPROCEDURE

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 A
Povidone-iodine SwabPROCEDURE

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

Also known as: Control
Group B

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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 the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr. Ruth K. M. Pfau Civil Hospital Karachi

Karachi, Sindh, 74400, Pakistan

RECRUITING

MeSH Terms

Conditions

Surgical Wound InfectionSurgical WoundWound InfectionSeroma

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

InfectionsPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsWounds and InjuriesInflammation

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Omer Bin Khalid, Assist Prof.

    Dr. Ruth F. M. Pfau Civil Hospital Karachi

    PRINCIPAL INVESTIGATOR

  • Imrana Zulfikar, Professor

    Dr. Ruth F. M. Pfau Civil Hospital Karachi

    STUDY DIRECTOR

Central Study Contacts

Omer Bin Khalid, Assist Prof.

CONTACT

+92 321 2040064dromerkhalid@gmail.com

Afeera Ahmed, Undergraduate

CONTACT

+923352547330afeeranws@gmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator (Assistant Professor)

Study Record Dates

First Submitted

July 19, 2023

First Posted

August 14, 2023

Study Start

April 29, 2023

Primary Completion

September 29, 2025

Study Completion

December 29, 2025

Last Updated

June 18, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)