Antibiotic Prophylaxis in Pediatric Open Fractures

NCT ID: NCT06055712

Last Updated: 2025-10-17

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: PHASE4
• Total Enrollment: 800 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-11
• Study Completion Date: 2034-01-31

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 cefazolin, 24 hours intravenous cefazolin, and 24 hours intravenous cefazolin plus 5 days of oral 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.

Conditions

Fractures, Open; Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

One dose of IV cefazolin

Patients in group A will receive one dose of IV cefazolin and will have no further antibiotic administration.

Group Type: ACTIVE_COMPARATOR

Cefazolin

Intervention Type: DRUG

Intravenous dose(s).

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).

Group Type: ACTIVE_COMPARATOR

Cefazolin

Intervention Type: DRUG

Intravenous dose(s).

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.

Group Type: ACTIVE_COMPARATOR

Cefazolin

Intervention Type: DRUG

Intravenous dose(s).

Cephalexin

Intervention Type: DRUG

Five days oral.

Interventions

Cefazolin

Intravenous dose(s).

Intervention Type: DRUG

Cephalexin

Five days oral.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 0 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

St. Louis University

OTHER

Sponsor Role: lead

Responsible Party

Raju Sivashanmugam

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sivashanmugam Raju, MD

Role: PRINCIPAL_INVESTIGATOR

St. Louis University

Locations

Saint Louis University

St Louis, Missouri, United States

Countries

United States

Other Identifiers

30873

Identifier Type: -

Identifier Source: org_study_id