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

April 28, 2026 updated by: Rohit Shrestha, Kathmandu University School of Medical Sciences

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Nepal
    • Bagmati
      • Dhulikhel, Bagmati, Nepal
        • Dhulikhel Hospital, Kathmandu University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard Course Antibiotics
Nine postoperative doses of cefuroxime 750 mg; each dose every eight hours for three days
Drug: Standard Course Antibiotics
Nine postoperative doses of cefuroxime 750 mg; each dose eight hours apart
Experimental: Short Course Antibiotics
Drug: Short Course Antibiotics
Three postoperative doses of cefuroxime 750 mg; each dose eight hours apart

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From enrollment to the end of postoperative follow up at six week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kathmandu University School of Medical Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 15, 2024

Primary Completion (Actual)

November 8, 2025

Study Completion (Actual)

November 8, 2025

Study Registration Dates

First Submitted

April 21, 2026

First Submitted That Met QC Criteria

April 21, 2026

First Posted (Actual)

April 28, 2026

Study Record Updates

Last Update Posted (Actual)

May 4, 2026

Last Update Submitted That Met QC Criteria

April 28, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 43/24

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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