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Extended Oral Antibiotic Prophylaxis in Diabetic Fracture Patients

RECRUITINGPhase 4Sponsored by Texas Tech University Health Sciences Center, El Paso
Actively Recruiting
PhasePhase 4
SponsorTexas Tech University Health Sciences Center, El Paso
Started2026-04-01
Est. completion2027-12-31
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations3 sites

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

Age: 18 Years+Healthy volunteers accepted
Inclusion Criteria:

* 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 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 with follow-up

Conditions3

DiabetesFracture Fixation, InternalFracture Lower Leg

Interventions3

Locations3 sites

California

1 site
USC
Los Angeles, California, 90033
Sarah Blumenthal, MD800-872-2273Sarah.Blumenthal@med.usc.edu

Texas

2 sites
University Medical Center of El Paso
El Paso, Texas, 79905
Taylor Yong8322027406tayong@ttuhsc.edu
Texas Tech Health El Paso
El Paso, Texas, 79912
Taylor M Yong, MD, MS915-215-5480tayong@ttuhsc.edu

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