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

Locations

3
University of Southern California90033, Los AngelesCalifornia, United States
Texas Tech Health El Paso79912, El PasoTexas, United States
University Medical Center of El Paso79905, El PasoTexas, United States

Sponsors and collaborators

Texas Tech University Health Sciences Center, El Paso

Lead sponsor

University of Southern California

Collaborator