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RECRUITING
NCT07338773
PHASE4

Intraosseous vs. Intravenous Vancomycin Prophylaxis for Diabetic Foot Amputations: A Randomized Trial

Sponsor: Başakşehir Çam & Sakura City Hospital

View on ClinicalTrials.gov

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

Official title: Comparison of the Effects of Intraosseous and Intravenous Vancomycin Prophylaxis on Surgical Site Infections and Clinical Outcomes After Diabetic Foot Amputation: A Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2025-09-03

Completion Date

2026-06-19

Last Updated

2026-01-16

Healthy Volunteers

No

Interventions

DRUG

Intraosseous Vancomycin

A single dose of 500 mg Vancomycin is administered into the bone marrow (intraosseous route) to achieve high local tissue concentrations at the surgical site.

DRUG

Intravenous Vancomycin

A single dose of 500 mg Vancomycin is administered via systemic intravenous infusion for standard prophylactic care.

Locations (1)

Basaksehir Cam ve Sakura City Hospital

Istanbul, Turkey (Türkiye)