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
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
Description
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 si…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 wi…
Interventions
- DrugCefadroxil 500 mg Capsules
Cefadroxil 500 mg, twice a day for 7 days
- DrugClindamycin
Clindamycin 300 mg, three times a day for 7 days
- DrugBactrim DS
Bactrim DS, twice a day for 7 days
Locations (3)
- University of Southern CaliforniaLos Angeles, California
- University Medical Center of El PasoEl Paso, Texas
- Texas Tech Health El PasoEl Paso, Texas