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.
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
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
378
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.
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China
RECRUITINGNumber 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.
Time frame: 30 days after the surgery
30-day mortality
Time frame: 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).
Time frame: 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.
Time frame: 30 days after surgery
Postoperative hospital stay
Time frame: 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.
Time frame: Other infections occurred within 30 days after surgery.
Number of Participants with unplanned readmission and secondary surgery
Time frame: Unplanned readmission and secondary surgery within 30 days after surgery.
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