The Treatment of Type I Open Fractures in Pediatrics

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age3-14
SponsorAnn & Robert H Lurie Children's Hospital of Chicago

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Formal Operative Treatment

    Procedure/Surgery

    Children 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/Surgery

    Children in the ED arm will have a washout in the emergency room under conscious sedation, a closed reduction and home antibiotics.

Treatment groups

300 Participants
are divided into 2 treatment groups
Group A: Formal Operative TreatmentOther 1 intervention
Group B: Emergency Department TreatmentOther 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
2 weeks

Secondary outcomes

1

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.

Time frame
24 weeks
2

Return visits to OR

Number of return visits to the operating room

Time frame
24 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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