By InvitationPhase 4

Antibiotic Prophylaxis in Pediatric Open Fractures

United States800 participantsStarted 2023-09-11

Plain-language 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 cefazolin, 24 hours intravenous cefazolin, and 24 hours intravenous cefazolin plus 5 days of oral cephalexin.

Who can participate

Age range0 Years – 17 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Number of participants with an infection at the fracture site.

Timeframe: Up to 3 months following injury.

Trial details

NCT IDNCT06055712

SponsorSt. Louis University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2033-09

View on ClinicalTrials.gov More Fractures, Open trials