Extended Oral Antibiotics for Diabetic Fracture Patients

This study is looking into whether taking an antibiotic pill for 7 days after surgery can lower the chance of wound infection in adults with poorly controlled diabetes who have a broken bone in their leg, ankle, or foot. You might be eligible if you are 18 or older, have a lower leg fracture needing surgery, and have uncontrolled diabetes (Hemoglobin A1c greater than 7.0 or random glucose greater than 200 mg/dL). Researchers will compare a 7-day course of Cefadroxil 500 mg (or Clindamycin or Bactrim DS if needed) to standard care (no extra antibiotics after surgery). The main goal is to see if this extended antibiotic course reduces surgical site infections within 90 days and what side effects might occur. The study aims to enroll 40 participants, but its current status is unclear.

Study design
This interventional study plans to enroll 40 participants. It will compare a 7-day course of an oral antibiotic to standard care.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for surgical site infection for 90 days after surgery.

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NCT07561541

Extended Oral Antibiotic Prophylaxis in Diabetic Fracture Patients

Recruiting
PHASE4Ages 18+InterventionalPrevention
Texas Tech University Health Sciences Center, El Paso
~40 participants
Updated 2026-05-08 on ClinicalTrials.gov
What's tested:Cefadroxil 500 mg CapsulesClindamycinBactrim DS

At a glance

Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Surgical site infection
Measured over 90 days
Fracture Lower Leg
Diabetes
Fracture Fixation, Internal
3 sites across 2 states
Texas2
California1

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Eligibility criteria

Inclusion

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
English or Spanish speaker

Exclusion

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
  • Surgical site infection90 days

    Incidence of superficial infection (a wound with erythema, warmth, or drainage that is treated with oral antibiotics or wound care) and deep infection (per fracture-related infection definition).