Actively Recruiting

Phase 4
Age: 18Years +
All Genders
NCT07561541

Extended Oral Antibiotic Prophylaxis in Diabetic Fracture Patients

Led by Texas Tech University Health Sciences Center, El Paso · Updated on 2026-05-08

40

Participants Needed

3

Research Sites

91 weeks

Total Duration

On this page

Sponsors

T

Texas Tech University Health Sciences Center, El Paso

Lead Sponsor

U

University of Southern California

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

Extended Oral Antibiotic Prophylaxis in Diabetic Fracture Patients

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 3 locations

1

University of Southern California

Los Angeles, California, United States, 90033

Actively Recruiting

2

University Medical Center of El Paso

El Paso, Texas, United States, 79905

Actively Recruiting

3

Texas Tech Health El Paso

El Paso, Texas, United States, 79912

Actively Recruiting

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Research Team

T

Taylor M Yong, MD, MS

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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Extended Oral Antibiotic Prophylaxis in Diabetic Fracture Patients | DecenTrialz