The Treatment of Type I Open Fractures in Pediatrics

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.

NCT Number	NCT00870064
Lead Sponsor	Ann & Robert H Lurie Children's Hospital of Chicago Collaborators: Provincial Health Services Authority British Columbia, University of Mississippi Medical Center, MultiCare Mary Bridge Children's Hospital & Health Center, Yale New Haven Health System Center for Healthcare Solutions, University of New Mexico Carrie Tingley Hospital, IWK Health Centre, Phoenix Children's Hospital, Children's Hospital Colorado, Nationwide Children's Hospital, Morristown Medical Center, NYUMC-Hospital for Joint Diseases, Children's Medical Center Dallas, Johns Hopkins University, Orthopaedic Institute for Children, Children's Hospital Los Angeles, St. Christopher's Hospital for Children, Children's Hospital of Orange County
Conditions	Fractures, Open
Enrollment	300 participants
Start Date	2010-03
Primary Completion	2027-06 (estimated)
Study Completion	2027-09 (estimated)
Updated on ClinicalTrials.gov	2026-07-01