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NOT YET RECRUITING
NCT07043855
NA

Duration of Perioperative Antibiotics in Pancreatoduodenectomy

Sponsor: Asan Medical Center

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to learn if different prophylactic antibiotic regimens can prevent surgical site infections in adult patients undergoing pancreatoduodenectomy. The main questions it aims to answer are: Does a single preoperative dose of cefazolin reduce the risk of surgical site infection? Does a three-day combination of cefotaxime plus metronidazole reduce the risk of surgical site infection? Researchers will compare a single dose of cefazolin to a three-day course of cefotaxime + metronidazole to see if there is a difference in postoperative infection rates. Participants will: * Be randomly assigned to one of two antibiotic regimens before and after surgery * Receive either Arm A: one dose of cefazolin immediately before surgery Arm B: cefoxitin for perioperative antibiotics followed by cefotaxime plus metronidazole administered for three days after surgery * Undergo routine postoperative monitoring for signs of infection * Have any surgical site infections and related complications recorded until 30 days after surgery

Official title: Duration of Perioperative Antibiotic Prophylaxis in Patients Undergoing Pancreatoduodenectomy: a Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

558

Start Date

2025-08

Completion Date

2027-10

Last Updated

2025-07-02

Healthy Volunteers

No

Interventions

DRUG

single dose preoperative antibiotic

Arm A is a single preoperative dose of cefazolin administered immediately before surgery

DRUG

Prolonged perioperative antibiotics

Preoperative Single-Dose Cefoxitin followed by Three-Day Cefotaxime and Metronidazole Prophylaxis

Locations (1)

Asan Medical Center

Seoul, South Korea