Prophylactic Antibiotics in Preventing Surgical Site Infection After Hepatobiliary Surgery in High-Resistant Settings: A Randomized Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 378
- Locations
- 1
Study Overview
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.
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Investigators
Chen Dayu
Pharmacist in Charge
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School