Extended Oral Antibiotic Prophylaxis in Diabetic Fracture Patients

Part of paid clinical trials in Los Angeles, California.

Sponsor
Texas Tech University Health Sciences Center, El Paso
Study ID
NCT07561541
Phase
PHASE4
Status
Recruiting
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Conditions

  • Diabetes
  • Fracture Fixation, Internal
  • Fracture Lower Leg

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cefadroxil 500 mg Capsules — DRUG
    Cefadroxil 500 mg, twice a day for 7 days
  • Clindamycin — DRUG
    Clindamycin 300 mg, three times a day for 7 days
  • Bactrim DS — DRUG
    Bactrim DS, twice a day for 7 days

Study Details

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

Key Dates

Start date
Apr 1, 2026
Status verified
May 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • No Intervention: No extended oral antibiotic prophylaxis
    No additional extended oral antibiotic prophylaxis beyond institutional perioperative protocols.
  • Experimental: Extended oral antibiotic prophylaxis
    Extended oral antibiotic therapy in addition to institutional protocols for perioperative antibiotic therapy

Primary Outcome Measure

Surgical site infection [ Time Frame: 90 days ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
University of Southern CaliforniaLos AngelesCalifornia90033
Sarah Blumenthal, MD
[email protected]
800-872-2273
Texas Tech Health El PasoEl PasoTexas79912
Taylor M Yong, MD, MS
[email protected]
915-215-5480
University Medical Center of El PasoEl PasoTexas79905
Taylor Yong
[email protected]
8322027406

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By research site
University of Southern California· Los Angeles, CATexas Tech Health El Paso· El Paso, TXUniversity Medical Center of El Paso· El Paso, TX

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