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: A Randomized Clinical Trial

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.

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.

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.