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Standard Versus Short Course Prophylactic Antibiotic in Femur and Tibia Shaft Fractures Managed With Intramedullary Interlocking Nail: A Prospective Randomized Comparative Study Using the ASEPSIS Score
Sponsor: Kathmandu University School of Medical Sciences
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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
56
Start Date
2024-02-15
Completion Date
2025-11-08
Last Updated
2026-04-28
Healthy Volunteers
No
Conditions
Interventions
Short Course Antibiotics
Three postoperative doses of cefuroxime 750 mg; each dose eight hours apart
Standard Course Antibiotics
Nine postoperative doses of cefuroxime 750 mg; each dose eight hours apart
Locations (1)
Dhulikhel Hospital, Kathmandu University Hospital
Dhulikhel, Bagmati, Nepal