Clinical trial NCT06055712: Antibiotic Prophylaxis in Pediatric Open Fractures
Official title: Antibiotic Prophylaxis in Pediatric Open Fractures
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE4
Conditions: Fractures, Open
Infections
Keywords: Pediatric open fracture
Antibiotic regimen
Infection rate
Lead sponsor: St. Louis University
Sponsor class: OTHER
First posted: 2023-09-28
Enrollment: 800
Sex: ALL
Minimum age (years): 0
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a prospective clinical trial in which patients will be assigned a study arm in sequential fashion.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of participants with an infection at the fracture site.
timeFrame: Up to 3 months following injury.
Secondary outcomes:
measure: Drug adverse events
timeFrame: Up to 3 months following injury.
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Saint Louis University
state: Missouri
Study officials:
affiliation: St. Louis University
name: Sivashanmugam Raju, MD
role: PRINCIPAL_INVESTIGATOR
References: