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Extended Oral Antibiotic Prophylaxis in Diabetic Fracture Patients

NCT07561541 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-05-08

No results posted yet for this study

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

Conditions

  • Fracture Lower Leg
  • Diabetes
  • Fracture Fixation, Internal

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

Sponsors & Collaborators

  • University of Southern California

    collaborator OTHER

  • Texas Tech University Health Sciences Center, El Paso

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-01
Primary Completion
2027-12-31
Completion
2027-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07561541 on ClinicalTrials.gov