Extended Oral Antibiotic Prophylaxis in Diabetic Fracture Patients
Extended Oral Antibiotic Prophylaxis in Diabetic Patients With Lower Extremity Fracture: A Multicenter Pilot Randomized Controlled Trial
Texas Tech University Health Sciences Center, El Paso
40 participants
Apr 1, 2026
INTERVENTIONAL
Conditions
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
Eligibility
Inclusion Criteria5
- Low extremity fracture requiring surgical treatment
- Uncontrolled diabetes (HbA1c > 7.0 or random glucose > 200 mg/dL)
- Age 18 years or older
- Able to provide informed consent
- English or Spanish speaker
Exclusion Criteria7
- 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
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Interventions
Cefadroxil 500 mg, twice a day for 7 days
Clindamycin 300 mg, three times a day for 7 days
Bactrim DS, twice a day for 7 days
Locations(3)
View Full Details on ClinicalTrials.gov
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NCT07561541