Health Trials

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

ConditionSurgical Site Infection (SSI)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSylhet M.A.G.Osmani Medical College

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients aged 18 years and above

Patients undergoing emergency laparotomy for contaminated surgical pathology

Patients undergoing emergency laparotomy for dirty/infected surgical pathology

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

90 Participants
are divided into 2 treatment groups
Group A: Levofloxacin Infiltration GroupExperimental treatment 1 intervention
Group B: Standard Care GroupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Incidence of Surgical Site Infection (SSI)

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.

Time frame
30 days postoperatively

Secondary outcomes

1

Type of Surgical Site Infection

Classification of surgical site infections occurring in each group as superficial incisional, deep incisional, or organ/space SSI, per CDC/NHSN criteria.

Time frame
30 days postoperatively
2

Microbiological Profile of Wound Infections

Organisms isolated from wound swab culture in patients diagnosed with surgical site infection in each group.

Time frame
30 days postoperatively

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sylhet M.A.G.Osmani Medical College

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: