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NCT Number: NCT05989386

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

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.

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Key information

Conditions

Surgical Site Infection Emergency Laparotomies Infections Inflammation Laparotomies Pathologic Processes Pathological Conditions, Signs and Symptoms Post Operative Wound Infection Postoperative Complications Seroma Surgical Incision Surgical Wound Surgical Wound Infection Wound Infection Wounds and Injuries

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Dr. Ruth K. M. Pfau Civil Hospital Karachi

Karachi, Sindh, 74400, Pakistan

Location status: Recruiting

Location contact

Afeera Bashir, Undergrad.

SUB_INVESTIGATOR

Azzam Ali, Undergrad.

SUB_INVESTIGATOR

Bushra Saeed Khan, FCPS-I

SUB_INVESTIGATOR

Imrana Zulfikar, FCPS-II

SUB_INVESTIGATOR

Omer Bin Khalid, FCPS-II

PRINCIPAL_INVESTIGATOR

Omer Bin khalid, Asst. Prof

CONTACT

[email protected]

+92 321 2040064

Rabbiyya Ali, FCPS-II

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

0.9% saline solution

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.

Povidone-iodine Swab

Procedure

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

Other names: Control

Primary outcomes

  1. Incidence of Superficial Surgical site infections

    Time frame: Upto 4 weeks post-operatively

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

Secondary outcomes

  1. Length of Hospital Stay

    Time frame: Upto 4 weeks post-operatively

    Number of in-hospital days (from time of admission to time of discharge)

Study contacts

Contact information is provided by the study sponsor or research team.

Afeera Ahmed, Undergraduate

CONTACT

[email protected]

+923352547330

Omer Bin Khalid, Assist Prof.

CONTACT

[email protected]

+92 321 2040064

Sponsors and collaborators

Lead sponsor

Dow University of Health Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Aug 14, 2023
Registry last updated
Jun 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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