RecruitingPhase 4NCT07561541

Extended Oral Antibiotic Prophylaxis in Diabetic Fracture Patients

Extended Oral Antibiotic Prophylaxis in Diabetic Patients With Lower Extremity Fracture: A Multicenter Pilot Randomized Controlled Trial


Sponsor

Texas Tech University Health Sciences Center, El Paso

Enrollment

40 participants

Start Date

Apr 1, 2026

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 18 Years

Inclusion Criteria5

  • Low extremity fracture requiring surgical treatment
  • Uncontrolled diabetes (HbA1c > 7.0 or random glucose > 200 mg/dL)
  • Age 18 years or older
  • Able to provide informed consent
  • English or Spanish speaker

Exclusion Criteria7

  • 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

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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)

USC

Los Angeles, California, United States

University Medical Center of El Paso

El Paso, Texas, United States

Texas Tech Health El Paso

El Paso, Texas, United States

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NCT07561541


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