Status:
ENROLLING_BY_INVITATION
Antibiotic Prophylaxis in Pediatric Open Fractures
Lead Sponsor:
St. Louis University
Conditions:
Fractures, Open
Infections
Eligibility:
All Genders
Up to 17 years
Phase:
PHASE4
Brief Summary
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 cefazoli...
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 present...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 11 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2034
Estimated Enrollment :
800 Patients enrolled
Trial Details
Trial ID
NCT06055712
Start Date
September 11 2023
End Date
January 1 2034
Last Update
October 17 2025
Active Locations (1)
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1
Saint Louis University
St Louis, Missouri, United States, 63110