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

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.

Study Overview

• Status: Recruiting
• Conditions: Hepatobiliary Surgery; Prophylactic Antibiotics
• Intervention / Treatment: Drug: Piperacillin-tazobactam

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.

• Study Type: Interventional
• Enrollment (Estimated): 378
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dayu Chen, Pharmacist in Charge, PharmD; Phone Number: +86-025-83106666-60924; Email: cdy_pharmacy@njglyy.com

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210008
      • Recruiting
      • Nanjing Drum Tower Hospital
      • Contact: Yao Du, Pharmacist in Charge; Phone Number: +86-025-83106666-60910; Email: dudu0083@126.com
      • Principal Investigator: Dayu Chen, PharmD
      • Principal Investigator: Yao Du

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group
Experimental: Intervention Group; Participants were randomized allocated to intervention group and receive piperacillin-tazobactam as prophylactic antibiotic before hepatobiliary surgery.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with surgical site infection within 30 days after 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.	30 days after the surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
30-day mortality		30 days after the surgery
Number of Participants with Sepsis within 30 days after surgery	Sepsis was defined according to criteria of the third international consensus of sepsis (doi: 10.1001/jama.2016.0287).	30 days after the surgery
Number of Participants with Postoperative bile leak or pancreas fisula	Postoperative bile leak and pancreas fisula was assessed by the treating surgeons.	30 days after surgery
Postoperative hospital stay		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	Infection was assessed by the treating surgeons.	Other infections occurred within 30 days after surgery.
Number of Participants with unplanned readmission and secondary surgery		Unplanned readmission and secondary surgery within 30 days after surgery.

Collaborators and Investigators

• Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Study record dates

Study Major Dates

• Study Start (Actual): May 24, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): January 31, 2029

Study Registration Dates

• First Submitted: May 21, 2026
• First Submitted That Met QC Criteria: May 27, 2026
• First Posted (Actual): June 2, 2026

Study Record Updates

• Last Update Posted (Actual): June 2, 2026
• Last Update Submitted That Met QC Criteria: May 27, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Antimicrobial resistance; Surgical site infection; Prophylactic antibiotic; Hepatobiliary Surgery
• Additional Relevant MeSH Terms: Postoperative Complications; Pathologic Processes; Infections; Wound Infection; Pathological Conditions, Signs and Symptoms; Surgical Wound Infection; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Pharmaceutical Preparations; Amides; Drug Combinations; Penicillin G; beta-Lactams; Lactams; Sulfones; Tazobactam; Penicillanic Acid; Piperacillin; Ampicillin; Penicillins; Piperacillin, Tazobactam Drug Combination
• Other Study ID Numbers: 2026-0252-02, 2026-0452-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No