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

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.

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.

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