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NCT Number: NCT07696819

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

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.

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Key information

Conditions

Surgical Site Infection (SSI) Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Surgical Wound Infection Wound Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Levofloxacin

Drug

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Study contacts

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

Pranto Chakroborty, MBBS

CONTACT

[email protected]

+8801735303838

Sylhet MAG Osmani Medical College Hospital

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Sylhet M.A.G.Osmani Medical College

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 10, 2026
Registry last updated
Jul 13, 2026

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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