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

NCT07696819 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2026-07-13

No results posted yet for this study

Summary

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.

Conditions

  • Surgical Site Infection (SSI)

Interventions

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.

Sponsors & Collaborators

  • Sylhet M.A.G.Osmani Medical College

    lead OTHER

Principal Investigators

  • Pranto Chakroborty, MBBS · Sylhet MAG Osmani Medical College Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-01
Primary Completion
2026-10-31
Completion
2026-10-31

Countries

  • Bangladesh

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07696819 on ClinicalTrials.gov