Rationale of Subcutaneous Levofloxacin Infiltration as an Adjunct for Surgical Site Infection Prevention in Emergency Laparotomy

July 10, 2026 updated by: Pranto Chakroborty, Sylhet M.A.G.Osmani Medical College

Surgical site infection (SSI) remains a major cause of postoperative morbidity following emergency laparotomy, particularly in contaminated and dirty/infected abdominal conditions. Systemic antibiotic prophylaxis alone often fails to achieve adequate local tissue concentrations at the incision site due to impaired perfusion, contributing to persistently high SSI rates in this population.

This trial evaluates subcutaneous infiltration of levofloxacin, a broad-spectrum fluoroquinolone with favorable tissue penetration, administered along the wound edges immediately prior to skin closure, as an adjunct to standard surgical and antibiotic management.

This study is investigator-initiated and will be conducted as a single-center trial within the Department of Surgery, Sylhet MAG Osmani Medical College Hospital.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Surgical site infection (SSI) remains a major cause of postoperative morbidity following emergency laparotomy, particularly in contaminated and dirty/infected abdominal conditions, where reported incidence ranges considerably higher than in elective clean surgery. Systemic antibiotic prophylaxis alone often fails to achieve adequate local tissue concentrations at the incision site due to impaired perfusion, contributing to persistently high SSI rates in this population.

This trial evaluates subcutaneous infiltration of levofloxacin, a broad-spectrum fluoroquinolone with favorable tissue penetration, administered along the wound edges immediately prior to skin closure, as an adjunct to standard surgical and antibiotic management. The infiltration dose is calculated based on wound surface area, using a levofloxacin solution prepared at 5 mg/mL concentration, with total dose kept within standard systemic dosing limits.

Participants will be followed for 30 days postoperatively, with structured wound assessments at postoperative day 3, day 7, and day 30. Wound infections will be classified according to CDC/NHSN criteria as superficial incisional, deep incisional, or organ/space SSI. Where infection is suspected, wound swabs will be sent for microbiological culture and antimicrobial sensitivity testing.

This study is investigator-initiated and will be conducted as a single-center trial within the Department of Surgery, Sylhet MAG Osmani Medical College Hospital.

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Bangladesh
      • Sylhet, Bangladesh, 3100
        • Sylhet MAG Osmani Medical College
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients aged 18 years and above
  • Patients undergoing emergency laparotomy for contaminated surgical pathology
  • Patients undergoing emergency laparotomy for dirty/infected surgical pathology

Exclusion Criteria:

  • Patients with known hypersensitivity to levofloxacin or other fluoroquinolones
  • Pregnant women or lactating mothers
  • Patients with pre-existing severe renal impairment
  • Patients with pre-existing skin infection at the incision site
  • Patients requiring re-laparotomy within 48 hours

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Levofloxacin Infiltration Group
Patients undergoing emergency laparotomy for contaminated or dirty/infected abdominal conditions will receive subcutaneous infiltration of levofloxacin solution (5 mg/mL) along both wound edges immediately before skin closure, in addition to standard surgical and perioperative management.
Drug: Levofloxacin
Levofloxacin solution (5 mg/mL) infiltrated subcutaneously along the wound edges at a dose calculated according to wound surface area (approximately 1 mL/cm²), not exceeding the standard maximum systemic dose, administered immediately prior to skin closure.
No Intervention: Standard Care Group
Patients undergoing emergency laparotomy for contaminated or dirty/infected abdominal conditions will receive standard surgical management and perioperative care alone, without subcutaneous levofloxacin infiltration.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Surgical Site Infection (SSI)
Time Frame: 30 days postoperatively
Proportion of patients developing surgical site infection within 30 days postoperatively, classified according to CDC/NHSN criteria as superficial incisional, deep incisional, or organ/space SSI, assessed through structured wound examination at postoperative day 3, day 7, and day 30.
30 days postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Type of Surgical Site Infection
Time Frame: 30 days postoperatively
Classification of surgical site infections occurring in each group as superficial incisional, deep incisional, or organ/space SSI, per CDC/NHSN criteria.
30 days postoperatively
Microbiological Profile of Wound Infections
Time Frame: 30 days postoperatively
Organisms isolated from wound swab culture in patients diagnosed with surgical site infection in each group.
30 days postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sylhet M.A.G.Osmani Medical College

Investigators

  • Principal Investigator: Pranto Chakroborty, MBBS, Sylhet MAG Osmani Medical College Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2026

Primary Completion (Estimated)

October 31, 2026

Study Completion (Estimated)

October 31, 2026

Study Registration Dates

First Submitted

July 6, 2026

First Submitted That Met QC Criteria

July 6, 2026

First Posted (Actual)

July 10, 2026

Study Record Updates

Last Update Posted (Actual)

July 13, 2026

Last Update Submitted That Met QC Criteria

July 10, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SOMCH-RCT-2026-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe