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

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

Recruiting
18 years and older
All
Phase N/A

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Overview

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.

Description

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.

Eligibility

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study details
    Hepatobiliary Surgery
    Prophylactic Antibiotics

NCT07620223

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

27 June 2026

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