The Treatment of Type I Open Fractures in Pediatrics



Status:Recruiting
Conditions:Orthopedic
Therapuetic Areas:Orthopedics / Podiatry
Healthy:No
Age Range:3 - 14
Updated:12/31/2017
Start Date:March 2010
End Date:October 2018
Contact:Jamie K Burgess, PhD, CCRP
Email:jburgess@luriechildrens.org
Phone:312-227-6531

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

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.

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 management. Children in the ED arm will have
a washout in the emergency room under conscious sedation, a closed reduction and home
antibiotics. Both wounds will be examined at interval follow up periods for signs of
infection. Outcomes evaluated will include the rate of infection, the number of return visits
to the operating room, the time to bone healing, and other complications. This is a pilot
study with the plan of eventually being a multicenter study evaluating open fracture care in
children.

Inclusion Criteria:

- 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 Criteria:

- 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)
We found this trial at
1
site
225 E Chicago Ave
Chicago, Illinois 60611
(312) 227-4000
Phone: 312-227-6194
Ann & Robert H. Lurie Children's Hospital of Chicago Ann & Robert H. Lurie Children
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mi
from
Chicago, IL
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