Hepatobiliary Surgery, Prophylactic Antibiotics
Conditions
Keywords
Hepatobiliary Surgery, Antimicrobial resistance, Prophylactic antibiotic, Surgical site infection
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.
Interventions
DRUGPiperacillin-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.
Sponsors
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 30-day mortality | 30 days after the surgery | — |
| Number of Participants with Sepsis within 30 days after surgery | 30 days after the surgery | Sepsis was defined according to criteria of the third international consensus of sepsis (doi: 10.1001/jama.2016.0287). |
| Number of Participants with Postoperative bile leak or pancreas fisula | 30 days after surgery | Postoperative bile leak and pancreas fisula was assessed by the treating surgeons. |
| 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. | Infection was assessed by the treating surgeons. |
| Number of Participants with unplanned readmission and secondary surgery | Unplanned readmission and secondary surgery within 30 days after surgery. | — |
Countries
China
Contacts
CONTACTDayu Chen, Pharmacist in Charge, PharmD
Outcome results
None listed