7-day oral antibiotic after surgery for people with diabetes and lower-leg fractures.
Extended Oral Antibiotic Prophylaxis in Diabetic Patients With Lower Extremity Fracture: A Multicenter Pilot Randomized Controlled Trial
This trial will test whether taking a 7-day antibiotic pill after surgery lowers wound infection risk in adults with poorly controlled diabetes who had surgery to fix a broken bone in the lower leg, ankle, or foot.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Texas Tech University Health Sciences Center, El Paso Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 3 sites (Los Angeles, California and 2 other locations) |
| Trial ID | NCT07561541 on ClinicalTrials.gov |
What this trial studies
Adults with poorly controlled diabetes and a closed lower-extremity fracture requiring surgical fixation are randomized to either a 7-day course of oral prophylactic antibiotic (cefadroxil 500 mg twice daily, with alternatives for allergy or MRSA) or to standard perioperative care without extended antibiotics. All participants receive standard IV perioperative antibiotics and the same fracture care, with follow-up contact about one week after surgery and clinic visits at 3 weeks, 6 weeks, and 3 months. Primary outcomes include superficial and deep surgical site infection within 90 days, with secondary outcomes of antibiotic-related adverse effects and medication adherence. The trial aims to balance potential infection reduction against safety and antibiotic stewardship concerns.
Who should consider this trial
Good fit: Adults (18+) with a closed lower-extremity fracture needing surgical fixation and poorly controlled diabetes (HbA1c >7.0 or random glucose >200 mg/dL), who can consent and speak English or Spanish, are ideal candidates.
Not a fit: Patients with open fractures, an active infection needing antibiotics, immunocompromised status, end-stage renal disease that prevents safe dosing, pregnancy or breastfeeding, known allergy to the study antibiotics, or inability to follow-up are unlikely to benefit.
Why it matters
Potential benefit: If effective, a short, targeted 7-day oral antibiotic could reduce postoperative wound infections and related complications in high-risk diabetic patients after lower-extremity fracture surgery.
How similar studies have performed: Some observational studies and small trials suggest extended antibiotics may reduce infections in high-risk orthopedic patients, but randomized evidence specifically in poorly controlled diabetic fracture patients is limited and mixed.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Where this trial is running
Los Angeles, California and 2 other locations
- University of Southern California — Los Angeles, California, United States (Recruiting)
- University Medical Center of El Paso — El Paso, Texas, United States (Recruiting)
- Texas Tech Health El Paso — El Paso, Texas, United States (Recruiting)
Study contacts
- Study coordinator: Taylor M Yong, MD, MS
- Email: tayong@ttuhsc.edu
- Phone: 915-215-5480
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.