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临床试验/NCT07696819
NCT07696819尚未招募不适用

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

Sylhet M.A.G.Osmani Medical College1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2026年8月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
90
试验地点
1
主要终点
Incidence of Surgical Site Infection (SSI)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged 18 years and above
  • Patients undergoing emergency laparotomy for contaminated surgical pathology
  • Patients undergoing emergency laparotomy for dirty/infected surgical pathology

排除标准

  • 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

研究组 & 干预措施

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.

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.

干预措施: Levofloxacin (Drug)

结局指标

主要结局

Incidence of Surgical Site Infection (SSI)

时间窗: 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.

次要结局

  • Type of Surgical Site Infection(30 days postoperatively)
  • Microbiological Profile of Wound Infections(30 days postoperatively)

研究者

发起方
Sylhet M.A.G.Osmani Medical College
申办方类型
Other
责任方
Principal Investigator
主要研究者

Pranto Chakroborty

FCPS Part-II Trainee (Neurosurgery)

Sylhet M.A.G.Osmani Medical College

研究点 (1)

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