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RECRUITING
NCT07561541
PHASE4

Extended Oral Antibiotic Prophylaxis in Diabetic Fracture Patients

Sponsor: Texas Tech University Health Sciences Center, El Paso

View on ClinicalTrials.gov

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

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2026-04-01

Completion Date

2027-12-31

Last Updated

2026-05-08

Healthy Volunteers

No

Interventions

DRUG

Cefadroxil 500 mg Capsules

Cefadroxil 500 mg, twice a day for 7 days

DRUG

Clindamycin

Clindamycin 300 mg, three times a day for 7 days

DRUG

Bactrim 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