Antibiotic Prophylaxis in Pediatric Open Fractures

This research will involve a prospective study on infection rates after grade 1 or 2 open fractures in the skeletally immature pediatric population. There will be 3 arms: one dose intravenous cefazolin, 24 hours intravenous cefazolin, and 24 hours intravenous cefazolin plus 5 days of oral cephalexin.

Study Overview

• Status: Enrolling by invitation
• Conditions: Infections; Fractures, Open
• Intervention / Treatment: Drug: Cefazolin; Drug: Cephalexin

Detailed Description

Pediatric patients presenting with open fractures will be screened for eligibility at the time of presentation. Informed consent form discussion will take place within 8 hours of the patient's presentation, or before their second dose of antibiotics would be due (if randomized to group 2 or 3).

Upon arrival to the ED with an open fracture (grade I or II), the patient is assessed and care is initiated based on patient presentation. Patients are given an IV for medication administration and receive the first dose of antibiotics (cefazolin) as soon as possible. This is standard of care.

Treatment of the fracture includes irrigation with saline (at least 1 liter depending on wound size). The fracture then needs to be stabilized and wound closed. Patients are taken to the trauma room typically within 8 hours of presentation for sedation and closed reduction of the fracture. These practices are standard of care.

If the patient and guardian consent to the study, the patient will be randomized to one of three study arms:

A) one dose of IV cefazolin B) 24 hours IV cefazolin (3 doses Q8hrs) C) 24 hours IV cefazolin (3 doses Q8hrs) plus 5 days oral cephalexin.

Patients in group A will have no further antibiotic administration, assuming they received their first (and only) dose as soon as possible upon arrival. Patients in groups B and C will need to receive their second doses of IV cefazolin 8 hours after administration of the first dose. This is why we plan to consent the patients/guardians within 8 hours of presentation.

Aside from antibiotic administration, all other treatment will be standard of care. Patients will undergo closed reduction and any other medical management deemed necessary. Prior to discharge, participants will be educated on how to identify symptoms of infection. It is standard of care to discuss this during discharge education.

Frequency of follow up will be determined by standard of care treatment plan for age and fracture type. This is at the discretion of the physician. Typical follow up is at 1 week then 1 or 2 week intervals for up to 8-12 weeks. Study team members will check the patient's medical record for indication of infection or adverse events at each follow-up visit. If no follow up is reported after three months, study staff will conduct a phone interview to collect this data.

• Study Type: Interventional
• Enrollment (Estimated): 800
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Missouri
    • St Louis, Missouri, United States, 63110
      • Saint Louis University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Pediatric patients ages 0-17 years old
• Skeletally immature patients, as confirmed by xray imaging evaluated by an orthopaedic surgeon
• Patient as sustained a grade 1 or 2 open fracture within 24 hours of presentation
• Physician plans to manage the fracture non-operatively

Exclusion Criteria:

• Patients 18 years or older
• Skeletally mature patients, as as confirmed by xray imaging evaluated by an orthopaedic surgeon
• Patients with grade 3 open fractures
• Gross contamination of the fracture
• Fracture requires surgery
• Immunocompromised patients
• Allergies to cephalosporins
• Severe penicillin allergy
• non-English speaking patients &/or guardian

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: One dose of IV cefazolin; Patients in group A will receive one dose of IV cefazolin and will have no further antibiotic administration.	Drug: Cefazolin; Intravenous dose(s).
Active Comparator: 24 hours IV cefazolin; Patients in group B will receive a dose of IV cefazolin every 8 hours for 24 hours (a total of 3 doses).	Drug: Cefazolin; Intravenous dose(s).
Active Comparator: 24 hours IV cefazolin plus 5 days oral cephalexin; Patients in group C will receive a dose of IV cefazolin every 8 hours for 24 hours (a total of 3 doses). Additionally, they will be instructed to take 5 days of oral cephalexin.	Drug: Cefazolin; Intravenous dose(s).; Drug: Cephalexin; Five days oral.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with an infection at the fracture site.	Participants will be monitored for infection at follow-up appointments and/or through follow-up phone contact.	Up to 3 months following injury.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Drug adverse events	Any adverse side effects resulting from antibiotics administered.	Up to 3 months following injury.

Collaborators and Investigators

• Sponsor: St. Louis University
• Investigators: Principal Investigator: Sivashanmugam Raju, MD, St. Louis University

Study record dates

Study Major Dates

• Study Start (Actual): September 11, 2023
• Primary Completion (Estimated): September 1, 2033
• Study Completion (Estimated): January 1, 2034

Study Registration Dates

• First Submitted: September 20, 2023
• First Submitted That Met QC Criteria: September 20, 2023
• First Posted (Actual): September 28, 2023

Study Record Updates

• Last Update Posted (Actual): October 20, 2025
• Last Update Submitted That Met QC Criteria: October 14, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Infection rate; Pediatric open fracture; Antibiotic regimen
• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone; Infections; Fractures, Open; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Amides; beta-Lactams; Lactams; Cephalosporins; Thiazines; Cefazolin; Cephalexin
• Other Study ID Numbers: 30873

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No