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Antibiotic Prophylaxis in Pediatric Open Fractures

Primary Purpose

Fractures, Open, Infections

Status
Enrolling by invitation
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Cefazolin
Cephalexin
Sponsored by
St. Louis University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Fractures, Open focused on measuring Pediatric open fracture, Antibiotic regimen, Infection rate

Eligibility Criteria

0 Years - 17 Years (Child)All SexesDoes not accept 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

Sites / Locations

  • Saint Louis University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

One dose of IV cefazolin

24 hours IV cefazolin

24 hours IV cefazolin plus 5 days oral cephalexin

Arm Description

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

Patients in group B will receive a dose of IV cefazolin every 8 hours for 24 hours (a total of 3 doses).

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Drug adverse events
Any adverse side effects resulting from antibiotics administered.

Full Information

First Posted
September 20, 2023
Last Updated
October 1, 2023
Sponsor
St. Louis University
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1. Study Identification

Unique Protocol Identification Number
NCT06055712
Brief Title
Antibiotic Prophylaxis in Pediatric Open Fractures
Official Title
Antibiotic Prophylaxis in Pediatric Open Fractures
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
September 11, 2023 (Actual)
Primary Completion Date
September 2033 (Anticipated)
Study Completion Date
January 2034 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. Louis University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fractures, Open, Infections
Keywords
Pediatric open fracture, Antibiotic regimen, Infection rate

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
This is a prospective clinical trial in which patients will be assigned a study arm in sequential fashion.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
800 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
One dose of IV cefazolin
Arm Type
Active Comparator
Arm Description
Patients in group A will receive one dose of IV cefazolin and will have no further antibiotic administration.
Arm Title
24 hours IV cefazolin
Arm Type
Active Comparator
Arm Description
Patients in group B will receive a dose of IV cefazolin every 8 hours for 24 hours (a total of 3 doses).
Arm Title
24 hours IV cefazolin plus 5 days oral cephalexin
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Cefazolin
Intervention Description
Intravenous dose(s).
Intervention Type
Drug
Intervention Name(s)
Cephalexin
Intervention Description
Five days oral.
Primary Outcome Measure Information:
Title
Number of participants with an infection at the fracture site.
Description
Participants will be monitored for infection at follow-up appointments and/or through follow-up phone contact.
Time Frame
Up to 3 months following injury.
Secondary Outcome Measure Information:
Title
Drug adverse events
Description
Any adverse side effects resulting from antibiotics administered.
Time Frame
Up to 3 months following injury.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
0 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sivashanmugam Raju, MD
Organizational Affiliation
St. Louis University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Saint Louis University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States

12. IPD Sharing Statement

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Antibiotic Prophylaxis in Pediatric Open Fractures

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