NCT07620223

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
378

participants targeted

Target at P75+ for not_applicable

Timeline
32mo left

Started May 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress2%
May 2026Jan 2029

First Submitted

Initial submission to the registry

May 21, 2026

Completed
3 days until next milestone

Study Start

First participant enrolled

May 24, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 2, 2026

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2029

Last Updated

June 2, 2026

Status Verified

May 1, 2026

Enrollment Period

2.6 years

First QC Date

May 21, 2026

Last Update Submit

May 27, 2026

Conditions

Hepatobiliary SurgeryProphylactic Antibiotics

Keywords

Hepatobiliary SurgeryAntimicrobial resistanceProphylactic antibioticSurgical site infection

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • 30-day mortality

    30 days after the surgery

  • Number of Participants with Sepsis within 30 days after surgery

    30 days after the surgery

  • Number of Participants with Postoperative bile leak or pancreas fisula

    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

    Other infections occurred within 30 days after surgery.

  • +1 more secondary outcomes

Study Arms (2)

Intervention Group

EXPERIMENTAL

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

Drug: Piperacillin-tazobactam

Control group

NO INTERVENTION

Interventions

Piperacillin-tazobactamDRUG

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.

Intervention Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, 210008, China

RECRUITING

MeSH Terms

Conditions

Surgical Wound Infection

Interventions

Piperacillin, Tazobactam Drug Combination

Condition Hierarchy (Ancestors)

Wound InfectionInfectionsPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TazobactamPenicillanic AcidPenicillinsbeta-LactamsLactamsAmidesOrganic ChemicalsPiperacillinAmpicillinPenicillin GSulfur CompoundsSulfonesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsDrug CombinationsPharmaceutical Preparations

Central Study Contacts

Dayu Chen, Pharmacist in Charge, PharmD

CONTACT

+86-025-83106666-60924cdy_pharmacy@njglyy.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: This is a single-centre, prospective, open-label, randomised pragmatic trial evaluating the efficacy of piperacillin-tazobactam as a perioperative prophylactic antimicrobial agent for the prevention of surgical site infection following hepatobiliary surgery in a high antimicrobial resistance setting. Participants in the intervention arm receive piperacillin-tazobactam for perioperative prophylaxis, whereas those in the control arm receive cefuroxime.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Pharmacist in Charge

Study Record Dates

First Submitted

May 21, 2026

First Posted

June 2, 2026

Study Start

May 24, 2026

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

January 31, 2029

Last Updated

June 2, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

CN(1)