Extended Oral Antibiotic Prophylaxis in Diabetic Fracture Patients

Recruiting now · Phase 4

Conditions studied: Fracture Lower Leg, Diabetes, Fracture Fixation, Internal

In brief

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

Key facts

Study ID

NCT07561541

Run by

Texas Tech University Health Sciences Center, El Paso

People needed

40

Starts

2026-04-01

Expected to finish

2027-12-31

Last updated by the study team

2026-05-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Low extremity fracture requiring surgical treatment
• Uncontrolled diabetes (Hemoglobin A1c > 7.0 or random glucose > 200 mg/dL)
• Age 18 years or older
• Able to provide informed consent
• English or Spanish speaker

You may not qualify if…

• Known allergy to prescribed antibiotic and pre-determined alternatives
• Open fractures
• Current infection requiring antibiotic treatment
• Immunocompromised status (chemotherapy, immunosuppressant medications)
• End-stage renal disease that medication dosing cannot be adjusted for
• Pregnant or breast-feeding
• Unable to comply with follow-up

Where it is running

• University of Southern California — Los Angeles, California, United States (enrolling)
• University Medical Center of El Paso — El Paso, Texas, United States (enrolling)
• Texas Tech Health El Paso — El Paso, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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