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

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Bactrim DS, a drug called Cefadroxil 500 mg Capsules, and others for people with diabetes, fracture fixation, internal, and other related conditions. The study is currently recruiting participants at 3 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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)

University of Southern California

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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