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Study for Type I Open Fractures in Children

This study is looking at the best way to treat a specific type of broken bone in children, called a Type I open fracture. This is when the bone breaks and there's a small wound in the skin, but the injury wasn't caused by a lot of force. Researchers want to see if treating these fractures in the emergency room with a washout (cleaning the wound), setting the bone, and antibiotics works as well as a formal surgery. Children aged 3 to 14 years old with these specific types of fractures can join. The main goal is to compare the rate of infection in both treatment groups after two weeks.

Study design
This is an interventional study with a planned enrollment of 300 children. Participants will be randomly assigned to receive either formal operative treatment or emergency department treatment.
What's involved
Children in the formal operative treatment group will have surgery within 24 hours. Children in the emergency department group will have a washout and bone setting in the emergency room and go home with antibiotics.
Compensation
Not stated in the trial record.
Follow-up
The rate of infection will be measured at 2 weeks after treatment.

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NCT00870064

The Treatment of Type I Open Fractures in Pediatrics

Recruiting
NAAges 3–14InterventionalTreatment
Ann & Robert H Lurie Children's Hospital of Chicago
~300 participants
Updated 2026-07-01 on ClinicalTrials.gov
What's tested:Formal Operative TreatmentEmergency Department Treatment

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Rate of infection
Measured over 2 weeks

Conditions

Fractures, Open

Explore related trials

Open Fracture

Where it's being run

1 sites across 1 states
Illinois1

Study leadership

  • Joseph (Jay) A Janicki, MD, MS · PRINCIPAL_INVESTIGATOR · Ann & Robert H Lurie Children's Hospital of Chicago

Who to contact

Jamie K Burgess, PhD, CCRP
[email protected]
312-227-6531
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Eligibility criteria

Inclusion

open fracture amenable to treatment by closed reduction
low energy mechanism of injury (e.g., falls from less than 10 feet, bicycle accidents)
wound less than 1cm in length and the bone not visualized through the skin

Exclusion

open fracture not amenable to treatment by closed reduction
open fracture that would typically require operative reduction and fixation
high energy mechanism of injury (e.g., struck by vehicle, motor vehicle accidents, fall from height greater than 10 feet)
wound greater than 1cm in length
gross contamination of wound
open fractures involving hands or feet (the current standard of care to treat open injuries involving hands or feet is only emergency room management)

What this trial measures

  • Rate of infection2 weeks

    1\. Do patients with type one open fractures treated in the emergency department with irrigation have a non-inferior rate of infections compared to those treated in the operating room with formal irrigation and debridement? The response variable will be the presence of an infection in children with open fractures.