Antibiotic Prophylaxis in Pediatric Open Fractures

Infections Clinical Trial

Official title:

Antibiotic Prophylaxis in Pediatric Open Fractures

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06055712
• Other study ID #: 30873
• Status: Enrolling by invitation
• Phase: Phase 4
• Start date: September 11, 2023
• Est. completion date: January 2034

Study information

• Verified date: October 2023
• Source: St. Louis University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 800
• Est. completion date: January 2034
• Est. primary completion date: September 2033
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Years to 17 Years

Eligibility

Inclusion Criteria:

• Pediatric patients ages 0-17 years old

• Skeletally immagure 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

Related Conditions & MeSH terms

• Fractures, Bone
• Fractures, Open
• Infections

Intervention

Drug:
• Cefazolin
Intravenous dose(s).
• Cephalexin
Five days oral.

Locations

Country	Name	City	State
United States	Saint Louis University	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
St. Louis University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with an infection at the fracture site.	Participants will be monitored for infection at follow-up appointments and/or through follow-up phone contact.	Up to 3 months following injury.
Secondary	Drug adverse events	Any adverse side effects resulting from antibiotics administered.	Up to 3 months following injury.