Prophylactic Antibiotics in Preventing Surgical Site Infection After Hepatobiliary Surgery in High-Resistant Settings
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Piperacillin-tazobactam.
- Who it may be relevant to
- Registry conditions: Hepatobiliary Surgery, Prophylactic Antibiotics. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Prophylactic Antibiotics in Preventing Surgical Site Infection After Hepatobiliary Surgery in High-Resistant Settings: A Randomized Clinical Trial
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.
Detailed 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.
Interventions
- Drug 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.
Primary outcome measures
- Number of participants with surgical site infection within 30 days after surgery [Time frame: 30 days after the surgery]
Secondary outcome measures (6)
- 30-day mortality [Time frame: 30 days after the surgery]
- Number of Participants with Sepsis within 30 days after surgery [Time frame: 30 days after the surgery]
- Number of Participants with Postoperative bile leak or pancreas fisula [Time frame: 30 days after surgery]
- Postoperative hospital stay [Time frame: 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 [Time frame: Other infections occurred within 30 days after surgery.]
- Number of Participants with unplanned readmission and secondary surgery [Time frame: Unplanned readmission and secondary surgery within 30 days after surgery.]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
China · 1 center
- Nanjing Drum Tower Hospital — Nanjing
Identifiers
NCT: NCT07620223 · 2026-0252-02, 2026-0452-03