RecruitingNot ApplicableNCT00870064

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


Sponsor

Ann & Robert H Lurie Children's Hospital of Chicago

Enrollment

300 participants

Start Date

Mar 1, 2010

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 3 YearsMax Age: 14 Years

Inclusion Criteria3

  • 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 Criteria6

  • 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)

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Interventions

PROCEDUREFormal 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.

PROCEDUREEmergency 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

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NCT00870064


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