About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Formal Operative Treatment
Procedure/SurgeryChildren 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
Procedure/SurgeryChildren in the ED arm will have a washout in the emergency room under conscious sedation, a closed reduction and home antibiotics.
Treatment groups
Trial outcomes
Primary outcomes
Rate of infection
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.
Secondary outcomes
Time to bone healing
2\. Do patients with type I open fractures who are treated nonoperatively have a non-inferior time to bone healing when compared to those treated operatively? The response variable will be time to clinical and radiographic fracture healing.
Return visits to OR
Number of return visits to the operating room
Sponsors and contacts
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Ann & Robert H Lurie Children's Hospital of Chicago
Lead sponsor
Provincial Health Services Authority British Columbia
Collaborator
University of Mississippi Medical Center
Collaborator
MultiCare Mary Bridge Children's Hospital & Health Center
Collaborator
Yale New Haven Health System Center for Healthcare Solutions
Collaborator
University of New Mexico Carrie Tingley Hospital
Collaborator
IWK Health Centre
Collaborator
Phoenix Children's Hospital
Collaborator
Children's Hospital Colorado
Collaborator
Nationwide Children's Hospital
Collaborator
Morristown Medical Center
Collaborator
NYUMC-Hospital for Joint Diseases
Collaborator
Children's Medical Center Dallas
Collaborator
Johns Hopkins University
Collaborator
Orthopaedic Institute for Children
Collaborator
Children's Hospital Los Angeles
Collaborator
St. Christopher's Hospital for Children
Collaborator
Children's Hospital of Orange County
Collaborator