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Antibiotic Prophylaxis in Pediatric Open Fractures

NCT06055712 · Status: ENROLLING_BY_INVITATION · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 800

Last updated 2025-10-17

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Cefazolin

Intravenous dose(s).

DRUG

Cephalexin

Five days oral.

Sponsors & Collaborators

  • St. Louis University

    lead OTHER

Principal Investigators

  • Sivashanmugam Raju, MD · St. Louis University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
0 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-11
Primary Completion
2033-09-30
Completion
2034-01-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06055712 on ClinicalTrials.gov