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The Treatment of Type I Open Fractures in Pediatrics
Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago
Summary
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.
Official title: The Treatment of Type I Open Fractures in Pediatrics: Evaluating the Necessity of Formal Irrigation and Debridement
Key Details
Gender
All
Age Range
3 Years - 14 Years
Study Type
INTERVENTIONAL
Enrollment
300
Start Date
2010-03
Completion Date
2026-06
Last Updated
2025-06-29
Healthy Volunteers
No
Conditions
Interventions
Formal Operative Treatment
Children randomized to the OR arm will be taken to the OR within 24 hours for irrigation and debridement and appropriate bone management.
Emergency Department Treatment
Children in the ED arm will have a washout in the emergency room under conscious sedation, a closed reduction and home antibiotics.
Locations (1)
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States