Antibiotic Prophylaxis in Pediatric Open Fractures

Enrolling by invitation · Phase 4

Conditions studied: Fractures, Open, Infections

In brief

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.

Key facts

Study ID

NCT06055712

Run by

St. Louis University

People needed

800

Starts

2023-09-11

Expected to finish

2034-01-01

Last updated by the study team

2025-10-20

Who can join

Age: any, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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