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COMPLETED
NCT07554079
NA

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

View on ClinicalTrials.gov

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

Interventions

DRUG

Short Course Antibiotics

Three postoperative doses of cefuroxime 750 mg; each dose eight hours apart

DRUG

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