Clinical Trials in China / NCT07620223
Recruiting
Not applicable
Prophylactic Antibiotics in Preventing Surgical Site Infection After Hepatobiliary Surgery in High-Resistant Settings
NCT07620223 · tracked via the Priya Life Science China tracker
Condition(s) studied
Hepatobiliary SurgeryProphylactic Antibiotics
Investigational drug(s) / intervention(s)
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.
Study 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.
Eligibility
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.
Primary outcome measure(s)
- Number of participants with surgical site infection within 30 days after surgery — 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.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Nanjing Drum Tower Hospital | Nanjing | Jiangsu | Recruiting |
More The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School trials in China
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07620223 on ClinicalTrials.gov ↗ ← All trials in China