Overview

INTRAOSSEOUS VS. INTRAVENOUS VANCOMYCIN PROPHYLAXIS FOR DIABETIC FOOT AMPUTATIONS: A PROSPECTIVE RANDOMIZED CONTROLLED TRIAL

Status:
RECRUITING

Trial end date:
2026-06-19

Target enrollment:

Participant gender:

Summary

he purpose of this study is to compare the effects of two different ways of giving the antibiotic vancomycin to prevent infections in patients undergoing amputation due to diabetic foot infection. Patients with diabetes often have poor blood circulation in their legs, which may prevent standard intravenous (IV) antibiotics from reaching the surgical site in high enough concentrations. This study compares: Intraosseous (IO) Administration: Giving the antibiotic directly into the bone at the amputation site during surgery. Intravenous (IV) Administration: Giving the antibiotic through a standard vein infusion before surgery. The researchers want to find out if the intraosseous method: Reduces the rate of surgical site infections compared to the standard IV method. Causes fewer changes in kidney function (measured by serum creatinine levels). Decreases the need for additional surgeries (reoperations) within 90 days. Patients will be randomly assigned to either the IO or IV group and will be followed for up to 90 days to evaluate their recovery and clinical outcomes

Phase:

PHASE4

Details

Lead Sponsor:

Baakehir am & Sakura City Hospital

Treatments:

Vancomycin