The Cost-Effectiveness of Extended Oral Antibiotic Prophylaxis for Infection Prevention After Total Joint Arthroplasty in High-Risk Patients.
Sophie Lipson, Nicholas R Pagani, Michael A Moverman...
https://pubmed.ncbi.nlm.nih.gov/35472436Actively Recruiting
Phase 4
Age: 18Years +
All Genders
ID07561541
Extended Oral Antibiotic Prophylaxis in Diabetic Patients With Lower Extremity Fracture: A Multicenter Pilot Randomized Controlled Trial
Led by Texas Tech University Health Sciences Center, El Paso · Updated on 2026-05-08
40
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
Sponsors
T
Texas Tech University Health Sciences Center, El Paso
Lead Sponsor
U
University of Southern California
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating if taking an oral antibiotic for 7 days after surgery can reduce wound infections in adults with poorly controlled diabetes who have surgery to fix a broken bone in the lower leg, ankle, or foot. This Phase 4 clinical trial compares an extended antibiotic course to the standard care of no additional antibiotics after surgery to understand its impact on infection rates and safety. Participants will be randomly assigned to receive either a 7-day course of oral antibiotics, such as cefadroxil twice daily or alternatives like clindamycin or Bactrim DS based on allergies or bacterial colonization, or no additional antibiotics beyond standard perioperative intravenous doses. Both groups will receive usual fracture care. The study includes follow-up phone calls and clinic visits at 3 weeks, 6 weeks, and 3 months after surgery. During the study, participants will be monitored for surgical site infections within 90 days after surgery and any antibiotic-related side effects. Researchers will also track how well participants follow the antibiotic regimen. The total participation involves initial treatment and follow-up visits over three months to assess outcomes and safety.
CONDITIONS
Brief Title
Extended Oral Antibiotic Prophylaxis in Diabetic Fracture Patients
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 7 days
Participants undergo surgical fixation of their lower extremity fracture and receive either a 7-day course of oral prophylactic antibiotics or standard care without extended antibiotics.
1 surgical visit plus daily oral medication for 7 days
Follow-up
Duration - Up to 90 days post-surgery
Participants are monitored for surgical site infections, antibiotic-related side effects, and adherence to the antibiotic regimen for up to 90 days after surgery.
Approximately 3 follow-up visits
Trial Site Locations
Total: 3 locations
1
University of Southern California
Los Angeles, California, United States, 90033
Actively Recruiting
2
University Medical Center of El Paso
El Paso, Texas, United States, 79905
Actively Recruiting
3
Texas Tech Health El Paso
El Paso, Texas, United States, 79912
Actively Recruiting
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Research Team
T
Taylor M Yong, MD, MS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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Published Research Related To This Trial
Extended Prophylactic Antibiotics for Primary and Aseptic Revision Total Joint Arthroplasty: A Meta-Analysis.
Suhas P Dasari, Sanjana D Kanumuri, JaeWon Yang...
https://pubmed.ncbi.nlm.nih.gov/38237874Extended Oral Antibiotic Prophylaxis in High-Risk Patients Substantially Reduces Primary Total Hip and Knee Arthroplasty 90-Day Infection Rate.
Avinash Inabathula, Julian E Dilley, Mary Ziemba-Davis...
https://pubmed.ncbi.nlm.nih.gov/30562290The AAHKS Clinical Research Award: Extended Oral Antibiotics Prevent Periprosthetic Joint Infection in High-Risk Cases: 3855 Patients With 1-Year Follow-Up.
Michael M Kheir, Julian E Dilley, Mary Ziemba-Davis...
https://pubmed.ncbi.nlm.nih.gov/33589279