Extended Oral Antibiotic Prophylaxis in Diabetic Fracture Patients

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorTexas Tech University Health Sciences Center, El Paso

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

40 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Texas Tech University Health Sciences Center, El Paso

Lead sponsor

University of Southern California

Collaborator