What this study is
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
What's being tested
- Cefadroxil 500 mg Capsules
Intervention · DRUG
Cefadroxil 500 mg, twice a day for 7 days
- Clindamycin
Intervention · DRUG
Clindamycin 300 mg, three times a day for 7 days
- Bactrim DS
Intervention · DRUG
Bactrim DS, twice a day for 7 days
Study details
- Official title
- 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
- Conditions
- Fracture Lower Leg · Diabetes · Fracture Fixation, Internal
- Enrolling
- 40 people
- Starts
- 2026-04-01
- Est. completion
- 2027-12-31
- Design
- Open-label, randomized, parallel groups, Phase 4
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (3)
3 openUniversity of Southern California
Los Angeles, California, United States
- Sarah Blumenthal, MD · Contact800-872-2273Sarah.Blumenthal@med.usc.edu
RecruitingUniversity Medical Center of El Paso
El Paso, Texas, United States
- Taylor Yong · Contact8322027406tayong@ttuhsc.edu
RecruitingTexas Tech Health El Paso
El Paso, Texas, United States
- Taylor M Yong, MD, MS · Contact915-215-5480tayong@ttuhsc.edu
Recruiting
Study team
Sponsor
Texas Tech University Health Sciences Center, El Paso
Study ID E26052
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.