A Phase III Multicenter, Open Label Randomized Controlled Trial of Cefoxitin versus Piperacillin-Tazobactam as Surgical Antibiotic Prophylaxis in Patients Undergoing Pancreatoduodenectomy
Categories (click each to see list of all clinical trials associated with that category): Gastrointestinal (GI)
Current Status: Open to accrual
Phase: III
Principal Investigator: Reames, Bradley
Contact Information:
Christina Hoy
+1 402-559-1577
christina.hoy@unmc.edu
Eligibility: https://www.clinicaltrials.gov/ct2/show/NCT03269994?cond=NCT03269994&draw=2&rank=1#eligibility
Summary
Compare the effectiveness of cefoxitin with piperacillin-tazobactam as surgical antibiotic prophylaxis in decreasing the overall rate of postoperative surgical site infections in participants undergoing pancreatoduodenectomy [ Time Frame: 30 days ]
To compare the effectiveness of cefoxitin, a second generation cephalosporin (Cohort 1), with piperacillin-tazobactam, a broad-spectrum penicillin (Cohort 2), as surgical antibiotic prophylaxis in decreasing the overall rate of postoperative SSIs in patients undergoing PD. 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.