Antibiotic Prophylaxis in Pediatric Open Fractures

Sponsor

St. Louis University (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT06055712

Collaborator

(none)

800

Enrollment

Location

Arms

123.7

Anticipated Duration (Months)

6.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Fractures, Open Infections	Drug: Cefazolin Drug: Cephalexin	Phase 4

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:

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

800 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

This is a prospective clinical trial in which patients will be assigned a study arm in sequential fashion.This is a prospective clinical trial in which patients will be assigned a study arm in sequential fashion.

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Antibiotic Prophylaxis in Pediatric Open Fractures

Actual Study Start Date :

Sep 11, 2023

Anticipated Primary Completion Date :

Sep 1, 2033

Anticipated Study Completion Date :

Jan 1, 2034

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: One dose of IV cefazolin Patients in group A will receive one dose of IV cefazolin and will have no further antibiotic administration.	Drug: Cefazolin Intravenous dose(s).
Active Comparator: 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).	Drug: Cefazolin Intravenous dose(s).
Active Comparator: 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.	Drug: Cefazolin Intravenous dose(s). Drug: Cephalexin Five days oral.

Arm

Intervention/Treatment

Active Comparator: One dose of IV cefazolin

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

Drug: Cefazolin

Intravenous dose(s).

Active Comparator: 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).

Drug: Cefazolin

Intravenous dose(s).

Active Comparator: 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.

Drug: Cefazolin

Intravenous dose(s).

Drug: Cephalexin

Five days oral.

Outcome Measures

Primary Outcome Measures

Number of participants with an infection at the fracture site. [Up to 3 months following injury.]
Participants will be monitored for infection at follow-up appointments and/or through follow-up phone contact.

Secondary Outcome Measures

Drug adverse events [Up to 3 months following injury.]
Any adverse side effects resulting from antibiotics administered.

Eligibility Criteria

Criteria

Ages Eligible for Study:

0 Years to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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