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Набор скоро начнётся NCT07696819

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

Без фазы С лечением Surgical Site Infection (SSI)

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Levofloxacin.
Кому может быть актуально
Состояния в реестре: Surgical Site Infection (SSI). Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Bangladesh
Следующий шаг
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Обзор

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.

Подробное описание

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.

Вмешательства

  • Препарат Levofloxacin
    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.

Первичные конечные точки

  • Incidence of Surgical Site Infection (SSI) [Срок оценки: 30 days postoperatively]
Вторичные конечные точки (2)
  • Type of Surgical Site Infection [Срок оценки: 30 days postoperatively]
  • Microbiological Profile of Wound Infections [Срок оценки: 30 days postoperatively]

Критерии участия

Критерии включения

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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Профилактика

Центры проведения

Bangladesh · 1 центр
  • Sylhet MAG Osmani Medical College — Sylhet

Идентификаторы

NCT: NCT07696819 · SOMCH-RCT-2026-01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗