Clinical trial Recruiting at 1 site Interventional Ages 18 and up

Prophylactic antibiotics to prevent surgical infections after hepatobiliary surgery in high-resistance settings

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

Run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · NCT07620223 · Data updated 2026-11-12

This study tests whether giving piperacillin-tazobactam before surgery can reduce surgical site infections in adults undergoing hepatobiliary operations in areas with high antibiotic resistance, compared with the standard cefuroxime approach.

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment378 (estimated)
SponsorThe Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Academic / other
Locations1 site (Nanjing, Jiangsu)
StatusRecruiting
StartedMay 24, 2026
Main results expectedDecember 31, 2028
Study endsJanuary 31, 2029
Registry record updatedJune 2, 2026
Trial IDNCT07620223 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults (18+) scheduled for elective hepatobiliary surgery without beta-lactam allergy and without major hepatic/renal impairment, who can consent.

Probably not a fit

Patients with beta-lactam allergies, unconstrained preoperative infections, severe organ dysfunction, or other contraindications may not benefit from this approach.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In settings with high antimicrobial resistance, this pragmatic trial compares two preoperative antibiotic strategies for hepatobiliary surgery. Patients receive either piperacillin-tazobactam or the standard cefuroxime for perioperative infection prevention. The study aims to see if the broader beta-lactam/beta-lactamase inhibitor combination lowers surgical site infection rates without introducing undue safety concerns. Eligibility includes adults undergoing elective hepatobiliary surgery who can provide informed consent. Exclusions apply to beta-lactam allergies, active preoperative infections, certain immunosuppressive treatments, organ failure, pregnancy, and concurrent trial participation.

Why it matters

Potential benefit: If successful, patients may have a lower risk of postoperative infections and related complications after hepatobiliary surgery.

How similar studies have gone: Prior evidence in high-resistance settings suggests prophylactic regimens can influence SSI rates, but this exact comparison in hepatobiliary surgery is relatively novel.

Who can join: the full rules

Show full inclusion / exclusion 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.

Where it's running

  • Nanjing Drum Tower Hospital
    Nanjing, Jiangsu, China
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.