Extended Oral Antibiotic Prophylaxis in Diabetic Patients With Lower Extremity Fracture: A Multicenter Pilot Randomized Controlled Trial
| Registry | NCT07561541 |
|---|---|
| Status | Recruiting |
| Phase | Phase 4 |
| Study type | Interventional; randomized, parallel, masking: none, prevention |
| Enrollment | 40 (Estimated) |
| Sponsor | Texas Tech University Health Sciences Center, El Paso (Other); collaborators: University of Southern California |
| Conditions | Fracture Lower Leg, Diabetes, Fracture Fixation, Internal |
| Interventions | Cefadroxil 500 mg Capsules, Clindamycin, Bactrim DS (Drug) |
| Dates | start 2026-04-01, primary completion 2027-12-31 (estimated), completion 2027-12-31 (estimated), first posted 2026-05-01, last updated 2026-05-08 |
| Locations | 3 sites in United States |
Related Papers Related Patents Related Grants Related Experts
All trials for Fracture Lower Leg All trials for Diabetes All trials of Cefadroxil 500 mg Capsules All trials of Clindamycin
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
The purpose of this research study is to investigate whether a 7-day course of an oral, prophylactic antibiotic following surgical fixation of a lower extremity fracture effectively decreases the risk of surgical site infection in patients with poorly controlled diabetes. Patients with an uncontrolled hemoglobin A1c greater than 7.0 or a random blood glucose greater than 200 mg/dL undergoing operative fixation of a closed fracture of the distal femur, patella, tibial plateau, tibial shaft, pilon, ankle, talus, calcaneus, or other operative foot fracture are considered high-risk for surgical site infection and are the target population for this study.
Study participants will be randomized to either a 7-day course of an oral prophylactic antibiotic following surgery (cefadroxil 500 mg twice daily, or an alternative regimen based on allergy status or methicillin-resistant Staphylococcus aureus colonization) or standard care with no additional antibiotics beyond the standard perioperative intravenous antibiotic dosing. All other standard perioperative fracture care will remain the same for both groups. Outcomes assessed will include superficial and deep surgical site infection occurring within 90 days of surgery, antibiotic-related adverse effects, and patient compliance with the extended antibiotic regimen.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| No extended oral antibiotic prophylaxis | No intervention | No additional extended oral antibiotic prophylaxis beyond institutional perioperative protocols. | |
| Extended oral antibiotic prophylaxis | Experimental | Drug: Cefadroxil 500 mg Capsules; Drug: Clindamycin; Drug: Bactrim DS | Extended oral antibiotic therapy in addition to institutional protocols for perioperative antibiotic therapy |
Sex: All, ages: 18 Years to any
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
| Facility | City | Country | Status |
|---|---|---|---|
| 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 |