Nanjing Drum Tower Hospital
Nanjing, Jiangsu, 210008, China
Location status: Recruiting
Location contact
Dayu Chen, PharmD
PRINCIPAL_INVESTIGATOR
Yao Du
PRINCIPAL_INVESTIGATOR
Yao Du, Pharmacist in Charge
CONTACT
NCT Number: NCT07620223
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Nanjing, Jiangsu, 210008, China
Location status: Recruiting
Dayu Chen, PharmD
PRINCIPAL_INVESTIGATOR
Yao Du
PRINCIPAL_INVESTIGATOR
Yao Du, Pharmacist in Charge
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 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.
Time frame: 30 days after the surgery
Time frame: 30 days after the 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 surgery
Postoperative bile leak and pancreas fisula was assessed by the treating surgeons.
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.
Time frame: Other infections occurred within 30 days after surgery.
Infection was assessed by the treating surgeons.
Time frame: Unplanned readmission and secondary surgery within 30 days after surgery.
Contact information is provided by the study sponsor or research team.
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Other
Prophylactic Antibiotics in Preventing Surgical Site Infection After Hepatobiliary Surgery in High-Resistant Settings: A Randomized Clinical Trial
Acronym: PASH
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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