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NCT07696819
Rationale of Subcutaneous Levofloxacin Infiltration as an Adjunct for Surgical Site Infection Prevention in Emergency Laparotomy
Conditions: Surgical Site Infection (SSI)
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 90
Sponsor: Sylhet M.A.G.Osmani Medical College
Location: Sylhet MAG Osmani Medical College Sylhet
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.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT07696819). StuddyBuddy aggregates publicly available trial information.