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OpenTrials
Enrolling by Invitation

NCT Number: NCT06055712

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.

Enrolling by Invitation

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Key information

Age range

0 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Saint Louis University

St Louis, Missouri, 63110, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cefazolin

Drug

Intravenous dose(s).

Cephalexin

Drug

Five days oral.

Primary outcomes

  1. Number of participants with an infection at the fracture site.

    Time frame: Up to 3 months following injury.

    Participants will be monitored for infection at follow-up appointments and/or through follow-up phone contact.

Secondary outcomes

  1. Drug adverse events

    Time frame: Up to 3 months following injury.

    Any adverse side effects resulting from antibiotics administered.

Sponsors and collaborators

Lead sponsor

St. Louis University

Other

Registry information

Important dates

Study start
2023
Primary completion
2033
Study completion
2034
First posted
Sep 28, 2023
Registry last updated
Oct 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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