Standard Versus Short Course Prophylactic Antibiotic in Femur and Tibia Shaft Fractures Managed With Intramedullary Interlocking Nail

Summary

Long-bone fractures, particularly of femur and tibia, are common following fall injury and road traffic accidents.1,2 The standard treatment is "intramedullary nailing," where a metal rod is inserted into the center of the bone to hold it in place.3,4 However, surgical site infection (SSI) and fracture related infection (FRI) remain significant complications of nailing that delay healing and increase healthcare costs.5,6 To prevent these infections, doctors give patients antibiotics around the time of surgery. However, there is ongoing debate about how long these antibiotics should be continued. In many regions, patients receive antibiotics for several days, but recent evidence suggests that a shorter course may be just as effective and could reduce the risk of antibiotic resistance and side effects. Study Question The goal of this study is to determine if a one-day (short) course of antibiotics is as effective as a three-day (standard) course in preventing infections after bone-nailing surgery. Hypotheses Null Hypothesis (H0): There is no significant difference in the incidence of infection or short-term clinical outcomes between the one-day (short-course) and three-day (standard-course) antibiotic protocols. Alternative Hypothesis (H1): There is a significant difference in the incidence of infection or short-term clinical outcomes between the one-day (short-course) and three-day (standard-course) antibiotic protocols.

Timeline

Start

2024-02-15

Primary completion

2025-11-08

Completion

2025-11-08

Publications

• Background Rodrigues FL, Ferrari ALM, Faria FF, Pinto RLE, Lopes MF, Santos MEA, Varela EC, Lopes Filho MJ, Cecyn MN, De Oliveira NHC. Epidemiology and Outcomes of Intramedullary Nailing for Tibial Diaphyseal Fractures: A Retrospective Multicenter Cohort Study. Cureus. 2025 Apr 24;17(4):e82894. doi: 10.7759/cureus.82894. eCollection 2025 Apr.
• Background Saleeb H, Tosounidis T, Papakostidis C, Giannoudis PV. Incidence of deep infection, union and malunion for open diaphyseal femoral shaft fractures treated with IM nailing: A systematic review. Surgeon. 2019 Oct;17(5):257-269. doi: 10.1016/j.surge.2018.08.003. Epub 2018 Aug 27.
• Background GBD 2019 Fracture Collaborators. Global, regional, and national burden of bone fractures in 204 countries and territories, 1990-2019: a systematic analysis from the Global Burden of Disease Study 2019. Lancet Healthy Longev. 2021 Sep;2(9):e580-e592. doi: 10.1016/S2666-7568(21)00172-0.

Drugs

Indications

No indication recorded.