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The Treatment of Type I Open Fractures in Pediatrics
The Treatment of Type I Open Fractures in Pediatrics: Evaluating the Necessity of Formal Irrigation and Debridement
Who can join
Ages 3 to 14 · All sexes
Full eligibility criteria
Inclusion Criteria: * 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 Criteria: * 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)
About the study
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.
What is being tested
- Formal Operative Treatment (procedure)
- Emergency Department Treatment (procedure)
Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago · Participants: 300 · Started: 2010-03
Contact the study team
- Jamie K Burgess, PhD, CCRP · Phone: 312-227-6531
- Michelle S Adzido, MA · Phone: 312-227-2492
Official record on ClinicalTrials.gov — NCT00870064
Locations in the U.S.
| Illinois | Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.