Surgical Site Infection (SSI)
Conditions
Keywords
Surgical Site Infection, Emergency Laparotomy, Subcutaneous Infiltration, Levofloxacin
Brief 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.
Detailed description
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.
Interventions
DRUGLevofloxacin
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
Sylhet M.A.G.Osmani Medical College
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Two parallel groups: intervention group receiving subcutaneous levofloxacin infiltration prior to skin closure, and control group receiving standard surgical management alone.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Surgical Site Infection (SSI) | 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
| Measure | Time frame | Description |
|---|---|---|
| Type of Surgical Site Infection | 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. |
| Microbiological Profile of Wound Infections | 30 days postoperatively | Organisms isolated from wound swab culture in patients diagnosed with surgical site infection in each group. |
Countries
Bangladesh
Contacts
CONTACTPranto Chakroborty, MBBS
CONTACTSylhet MAG Osmani Medical College Hospital
PRINCIPAL_INVESTIGATORPranto Chakroborty, MBBS
Sylhet MAG Osmani Medical College Hospital
Outcome results
None listed