About this trial
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 criteria
Qualifiers
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
Disqualifiers
Known allergy to prescribed antibiotic and pre-determined alternatives
Open fractures
Current infection requiring antibiotic treatment
Immunocompromised status (chemotherapy, immunosuppressant medications)
Trial design
Treatments tested in this trial
- Cefadroxil 500 mg Capsules
- Clindamycin
- Bactrim DS
Treatment groups
Sponsors and collaborators
Texas Tech University Health Sciences Center, El Paso
Lead sponsor
University of Southern California
Collaborator