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NCT Number: NCT07620223

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, 210008, China

Location status: Recruiting

Location contact

Dayu Chen, PharmD

PRINCIPAL_INVESTIGATOR

Yao Du

PRINCIPAL_INVESTIGATOR

Yao Du, Pharmacist in Charge

CONTACT

[email protected]

+86-025-83106666-60910

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Piperacillin-tazobactam

Drug

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 outcomes

  1. Number of participants with surgical site infection within 30 days after surgery

    Time frame: 30 days after the surgery

    The primary endpoint, overall SSI rate, is defined as superficial incisional SSI, deep incisional SSI, or organ/space SSI within the first 30 days after the operation, as defined according to the ACS NSQIP data collection operations manual.

Secondary outcomes

  1. 30-day mortality

    Time frame: 30 days after the surgery

  2. Number of Participants with Sepsis within 30 days after surgery

    Time frame: 30 days after the surgery

    Sepsis was defined according to criteria of the third international consensus of sepsis (doi: 10.1001/jama.2016.0287).

  3. Number of Participants with Postoperative bile leak or pancreas fisula

    Time frame: 30 days after surgery

    Postoperative bile leak and pancreas fisula was assessed by the treating surgeons.

  4. 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.

  5. Number of participants with infections other than surgical site infection

    Time frame: Other infections occurred within 30 days after surgery.

    Infection was assessed by the treating surgeons.

  6. Number of Participants with unplanned readmission and secondary surgery

    Time frame: Unplanned readmission and secondary surgery within 30 days after surgery.

Study contacts

Contact information is provided by the study sponsor or research team.

Dayu Chen, Pharmacist in Charge, PharmD

CONTACT

[email protected]

+86-025-83106666-60924

Sponsors and collaborators

Lead sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Other

Registry information

Official study title

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

Acronym: PASH

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Jun 2, 2026
Registry last updated
Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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