Prophylactic Antibiotics in Preventing Surgical Site Infection After Hepatobiliary Surgery in High-Resistant Settings

Официальное название

Prophylactic Antibiotics in Preventing Surgical Site Infection After Hepatobiliary Surgery in High-Resistant Settings: A Randomized Clinical Trial

Обзор

To analyse the efficacy of different preoperative prophylactic antimicrobial regimens for perioperative infection prevention in patients undergoing hepatobiliary surgery in a high antimicrobial resistance setting.

Подробное описание

Given the high incidence of postoperative surgical site infections (SSI) potentially attributable to bacterial antimicrobial resistance, the use of beta-lactam/beta-lactamase inhibitor combinations for prophylaxis may reduce SSI rates following hepatobiliary surgery in the current era of high antimicrobial resistance. To test this hypothesis, we propose a prospective pragmatic trial comparing piperacillin-tazobactam with the standard prophylactic regimen of cefuroxime for perioperative infection prevention in patients undergoing hepatobiliary surgery.

Вмешательства

• Препарат Piperacillin-tazobactam
  Participants were randomized allocated to intervention group and receive piperacillin-tazobactam as prophylactic antibiotic before hepatobiliary surgery. Participants in the cotrol group will receive cefuroxime for prophylactic antibiotic.

Первичные конечные точки

• Number of participants with surgical site infection within 30 days after surgery [Срок оценки: 30 days after the surgery]

Вторичные конечные точки (6)

• 30-day mortality [Срок оценки: 30 days after the surgery]
• Number of Participants with Sepsis within 30 days after surgery [Срок оценки: 30 days after the surgery]
• Number of Participants with Postoperative bile leak or pancreas fisula [Срок оценки: 30 days after surgery]
• Postoperative hospital stay [Срок оценки: Length of postoperative hospital stay from date of surgery until the date of first documented date of discharge from any cause, whichever came first, assessed up to 90 days.]
• Number of participants with infections other than surgical site infection [Срок оценки: Other infections occurred within 30 days after surgery.]
• Number of Participants with unplanned readmission and secondary surgery [Срок оценки: Unplanned readmission and secondary surgery within 30 days after surgery.]

Критерии участия

Критерии включения

• Adult patients aged ≥18 years;
• Deemed eligible for elective hepatobiliary surgery;
• Demonstrated comprehension of the study nature and expressed willingness to comply with trial procedures;
• Capable of providing written informed consent.

Критерии исключения

• History of β-lactam allergy or hypersensitivity
• Uncontrolled preoperative infection;
• Current or recent (within the preceding month) systemic corticosteroid administration;
• Severe hepatic or renal impairment;
• Pregnancy or lactation;
• Concurrent enrolment in another clinical trial;
• Any other condition deemed by the investigator to render the patient unsuitable for study participation.

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

Открытое

Основная цель

Профилактика

Центры проведения

Китай · 1 центр

• Nanjing Drum Tower Hospital — Нанкин

Идентификаторы

NCT: NCT07620223 · 2026-0252-02, 2026-0452-03

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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