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

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.

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Key information

Conditions

Fracture Femur Antibiotic Antibiotic Prescription Femoral Fractures Fracture Tibia Fractures, Bone Infections Leg Injuries Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Surgical Site Infection (SSI) Surgical Wound Infection Tibial Fractures Wound Infection Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dhulikhel Hospital, Kathmandu University Hospital

Dhulikhel, Bagmati, Nepal

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Adult patients (≥18 years)
Diaphyseal fractures of the femur (AO 32) or tibia (AO 42), including closed injuries and Gustilo-Anderson type I open fractures, who were scheduled for intramedullary interlocking nailing

Exclusion criteria

Polytrauma
Open fractures classified as Gustilo-Anderson type II or III
Procedures other than intramedullary nailing
Pregnancy
Comorbidities known to affect infection risk, such as diabetes mellitus, immunocompromised states, chronic steroid use, active skin or chest infections, or other conditions requiring alternative antibiotic regimens

Treatment and study plan

Short Course Antibiotics

Drug

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

Standard Course Antibiotics

Drug

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

Primary outcomes

Incidence of Wound Infection based on ASEPSIS score

Time frame: From enrollment to the end of postoperative follow up at six week

The primary outcome is the rate of wound infection as categorized by the ASEPSIS scoring system. The ASEPSIS score is a validated tool that evaluates wound healing based on clinical criteria (Additional treatment, Serous discharge, Erythema, Purulent exudate, Separation of deep tissues, Isolation of bacteria, and Stay as inpatient).

Satisfactory Healing: Score 0-10 Disturbance in Healing: Score 11-20 Infection: Score >20

The primary comparison will be the proportion of patients in each group reaching the "Wound Infection" category.

Sponsors and collaborators

Lead sponsor

Kathmandu University School of Medical Sciences

Other

Registry information

Official study title

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

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: Apr 28, 2026
Registry last updated: May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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