The Treatment of Type I Open Fractures in Pediatrics

Recruiting now · Not applicable

Conditions studied: Fractures, Open

In brief

Open fractures are frequently encountered in orthopaedics. Treatment usually calls for a formal, operative procedure in which the bone is exposed, foreign tissue is debrided and the wound is irrigated. While this is the current standard of care, not all open fractures are equal. In retrospective studies, centers are reporting less aggressive operative management for open fractures may result in equal results without the time and expense of the operative theater. The investigators propose a prospective, randomized trial of children with type I open fractures to evaluate whether formal operative treatment is necessary. The investigators' hypothesis is that minor open fractures can be safely treated in the emergency room with irrigation, closed reduction and home antibiotics without an increased risk of infection or other complications. Children who meet the study criteria will be randomized into two treatment arms - formal operative management (OR) and emergency department (ED) management. Outcomes from each group will be evaluated and compared, including rate of infection, number of return visits to the operating room, time to union, and other complications.

Key facts

Study ID

NCT00870064

Run by

Ann & Robert H Lurie Children's Hospital of Chicago

People needed

300

Starts

2010-03-01

Expected to finish

2027-09-01

Last updated by the study team

2026-07-01

Who can join

Age: 3 and older, up to 14. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago, Illinois, United States (enrolling)

Full record on ClinicalTrials.gov

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