Extended Oral Antibiotic Prophylaxis in Diabetic Fracture Patients

The purpose of this research study is to investigate whether a 7-day course of an oral, prophylactic antibiotic following surgical fixation of a lower extremity fracture effectively decreases the risk of surgical site infection in patients with poorly controlled diabetes. Patients with an uncontrolled hemoglobin A1c greater than 7.0 or a random blood glucose greater than 200 mg/dL undergoing operative fixation of a closed fracture of the distal femur, patella, tibial plateau, tibial shaft, pilon, ankle, talus, calcaneus, or other operative foot fracture are considered high-risk for surgical site infection and are the target population for this study.

Study participants will be randomized to either a 7-day course of an oral prophylactic antibiotic following surgery (cefadroxil 500 mg twice daily, or an alternative regimen based on allergy status or methicillin-resistant Staphylococcus aureus colonization) or standard care with no additional antibiotics beyond the standard perioperative intravenous antibiotic dosing. All other standard perioperative fracture care will remain the same for both groups. Outcomes assessed will include superficial and deep surgical site infection occurring within 90 days of surgery, antibiotic-related adverse effects, and patient compliance with the extended antibiotic regimen.

Inclusion criteria

• 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

Exclusion criteria

• 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