Actively Recruiting
The Treatment of Type I Open Fractures in Pediatrics
Led by Ann & Robert H Lurie Children's Hospital of Chicago · Updated on 2025-06-29
300
Participants Needed
1
Research Sites
848 weeks
Total Duration
On this page
Sponsors
A
Ann & Robert H Lurie Children's Hospital of Chicago
Lead Sponsor
P
Provincial Health Services Authority British Columbia
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The Treatment of Type I Open Fractures in Pediatrics
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- 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)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States, 60611
Actively Recruiting
Research Team
J
Jamie K Burgess, PhD, CCRP
CONTACT
C
Candace C Young, BS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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