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

Nanjing University

Status: Enrolling

Conditions: Prophylactic Antibiotics; Hepatobiliary Surgery

Treatments: Drug: Piperacillin-tazobactam

Study type: Interventional

Funder types: Other

Identifiers

NCT07620223

2026-0252-02, 2026-0452-03

Details and patient eligibility

About

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.

Full 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.

Enrollment: 378 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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378 participants in 2 patient groups

Intervention Group

Experimental group

Description:

Participants were randomized allocated to intervention group and receive piperacillin-tazobactam as prophylactic antibiotic before hepatobiliary surgery.

Treatment:

Drug: Piperacillin-tazobactam

Control group

No Intervention group