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Duration of Perioperative Antibiotics in Pancreatoduodenectomy

NCT07043855 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 558

Last updated 2025-07-02

No results posted yet for this study

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

Conditions

  • Pancreatoduodenectomy
  • PPPD
  • Infectious Complications

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

Sponsors & Collaborators

  • Asan Medical Center

    lead OTHER

Principal Investigators

  • Sung-Han Kim, MD, PhD · Asan Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-31
Primary Completion
2027-09-30
Completion
2027-10-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07043855 on ClinicalTrials.gov