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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Levofloxacin Infiltration Group | Experimental | Patients undergoing emergency laparotomy for contaminated or dirty/infected abdominal conditions will receive subcutaneous infiltration of levofloxacin solution (5 mg/mL) along both wound edges immediately before skin closure, in addition to standard surgical and perioperative management. |
|
| Standard Care Group | No Intervention | Patients undergoing emergency laparotomy for contaminated or dirty/infected abdominal conditions will receive standard surgical management and perioperative care alone, without subcutaneous levofloxacin infiltration. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 30 days postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 30 days postoperatively |
| Microbiological Profile of Wound Infections |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pranto Chakroborty, MBBS | Contact | +8801735303838 | pranto.cby@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sylhet MAG Osmani Medical College | Sylhet | 3100 | Bangladesh |
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Two parallel groups: intervention group receiving subcutaneous levofloxacin infiltration prior to skin closure, and control group receiving standard surgical management alone.
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Organisms isolated from wound swab culture in patients diagnosed with surgical site infection in each group. |
| 30 days postoperatively |
| ID | Term |
|---|---|
| D013530 | Surgical Wound Infection |
| ID | Term |
|---|---|
| D014946 | Wound Infection |
| D007239 | Infections |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D064704 | Levofloxacin |
| ID | Term |
|---|---|
| D015242 | Ofloxacin |
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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