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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• PATIENTS AGED 18 YEARS AND OLDER. DIAGNOSED WITH TYPE 1 OR TYPE 2 DIABETES MELLITUS. SCHEDULED FOR TRANSTIBIAL (BELOW-KNEE) AMPUTATION DUE TO DIABETIC FOOT INFECTION.

• WILLING AND ABLE TO PROVIDE WRITTEN INFORMED CONSENT.

Locations
Other Locations
Turkey
Basaksehir Cam ve Sakura City Hospital
RECRUITING
Istanbul
Contact Information
Primary
lezgin mert
lezginmert@gmail.com
+905056003904
Time Frame
Start Date: 2025-09-03
Estimated Completion Date: 2026-06-19
Participants
Target number of participants: 40
Treatments
Experimental: Intraosseous Vancomycin
500 mg Vancomycin hydrochloride dissolved in of %0.9 NaCl, administered directly into the intramedullary space.
Active_comparator: Intravenous Vancomycin
500 mg Vancomycin hydrochloride administered via peripheral intravenous infusion
Related Therapeutic Areas
Sponsors
Leads: Başakşehir Çam & Sakura City Hospital

This content was sourced from clinicaltrials.gov