Clinical Trial

Extended Oral Antibiotic Prophylaxis in Diabetic Fracture Patients

Recruiting Phase 4
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Summary
The goal of this clinical trial is to learn if taking an antibiotic pill for 7 days after surgery reduces the risk of wound infection in adults with poorly controlled diabetes who have surgery to fix a broken bone in the leg, ankle, or foot. It will also learn about the safety of the extended antibiotic course. The main questions it aims to answer are: Does a 7-day antibiotic course after surgery lower the rate of wound infection within 90 days? What medical problems do participants have when taking the extended antibiotic course? Researchers will compare a 7-day course of an oral antibiotic (cefadroxil) to standard care (no additional antibiotics after surgery) to see if the extended course reduces infections. Participants will: Take an antibiotic pill or receive standard care for 7 days after surgery Receive a phone call from the study team about 1 week after surgery Visit the clinic at 3 weeks, 6 weeks, and 3 months after surgery for checkups
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2026-04-24.
Trial Details
NCT Number NCT07561541
Lead Sponsor Texas Tech University Health Sciences Center, El Paso
Collaborators: University of Southern California
Conditions Fracture Lower Leg, Diabetes, Fracture Fixation, Internal
Enrollment 40 participants
Start Date 2026-04-01
Primary Completion 2027-12-31 (estimated)
Study Completion 2027-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-05-08