Clinical Trial: The Treatment of Type I Open Fractures in Pediatrics

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: The Treatment of Type I Open Fractures in Pediatrics: Evaluating the Necessity of Formal Irrigation and Debridement

Brief 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.

Detailed Summary:

Fractures in which bone has been exposed to the outside world through an associated skin injury, known as open fractures, are frequently encountered in orthopaedics. Traditionally, treatment calls for a formal, operative treatment in which the bone is exposed, foreign tissue is debrided and the wound is irrigated. The bone itself, depending on the age of the patient, fracture location and stability is then treated by the appropriate method of casting or internal fixation. However, while this is the current standard of care for all open fractures, not all open fractures are the same and can differ in terms of the bone involved, energy causing the injury and the skeletal maturity of the patient. Children, for example, have a thick periosteum which may diminish the rate of infection and decrease the time to healing. In addition, the protocol of operative debridement was introduced at the same time as widespread antibiotic use. It is not known whether the mechanical operative management or antibiotic use has resulted in improved outcomes. In retrospective studies, centers are reporting emergency department management alone may result in equal results without the time and expense of the operative theater.

We propose a prospective, randomized trial of children with type I open fractures to evaluate whether formal operative treatment is necessary. Our hypothesis is that minor open fractures in children can be safely treated in the emergency room with irrigation, closed reduction and home antibiotics without an increased risk of infection or other complications. If the inclusion criteria is met and informed consent is obtained, children will be randomized into two treatment arms - formal operative management (OR) and emergency department (ED) management. Children randomized to the OR arm will be taken to the OR within 24 hours for irrigation and debridement and appropriate bone m
Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago

Current Primary Outcome: Rate of infection [ Time Frame: 1, 2, 4, 6, 12, 24 weeks ]

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.


Original Primary Outcome: Rate of infection [ Time Frame: 1, 2, 4, 6, 12, 24 weeks ]

Current Secondary Outcome:

  • Time to bone healing [ Time Frame: 1, 2, 4, 6, 12, 24 weeks ]
    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.
  • Number of return visits to OR [ Time Frame: 1, 2, 4, 6, 12, 24 weeks ]


Original Secondary Outcome:

  • Time to bone healing [ Time Frame: 1, 2, 4, 6, 12, 24 weeks ]
  • Number of return visits to OR [ Time Frame: 1, 2, 4, 6, 12, 24 weeks ]


Information By: Ann & Robert H Lurie Children's Hospital of Chicago

Dates:
Date Received: March 25, 2009
Date Started: March 2010
Date Completion: October 2018
Last Updated: July 29, 2015
Last Verified: July 2015