Extended Oral Antibiotic Prophylaxis in Diabetic Fracture Patients

Summary

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

Timeline

Start

2026-04-01

Primary completion

2027-12-31

Completion

2027-12-31

Publications

• Background Lipson S, Pagani NR, Moverman MA, Puzzitiello RN, Menendez ME, Smith EL. The Cost-Effectiveness of Extended Oral Antibiotic Prophylaxis for Infection Prevention After Total Joint Arthroplasty in High-Risk Patients. J Arthroplasty. 2022 Oct;37(10):1961-1966. doi: 10.1016/j.arth.2022.04.025. Epub 2022 Apr 25.
• Background Dasari SP, Kanumuri SD, Yang J, Manner PA, Fernando ND, Hernandez NM. Extended Prophylactic Antibiotics for Primary and Aseptic Revision Total Joint Arthroplasty: A Meta-Analysis. J Arthroplasty. 2024 Sep;39(9 Suppl 2):S476-S487. doi: 10.1016/j.arth.2024.01.014. Epub 2024 Jan 17.
• Background Inabathula A, Dilley JE, Ziemba-Davis M, Warth LC, Azzam KA, Ireland PH, Meneghini RM. Extended Oral Antibiotic Prophylaxis in High-Risk Patients Substantially Reduces Primary Total Hip and Knee Arthroplasty 90-Day Infection Rate. J Bone Joint Surg Am. 2018 Dec 19;100(24):2103-2109. doi: 10.2106/JBJS.17.01485.
• Background Kheir MM, Dilley JE, Ziemba-Davis M, Meneghini RM. The AAHKS Clinical Research Award: Extended Oral Antibiotics Prevent Periprosthetic Joint Infection in High-Risk Cases: 3855 Patients With 1-Year Follow-Up. J Arthroplasty. 2021 Jul;36(7S):S18-S25. doi: 10.1016/j.arth.2021.01.051. Epub 2021 Jan 23.

Drugs

Indications