The Treatment of Type I Open Fractures in Pediatrics

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.

Conditions

• Fractures, Open

Interventions

PROCEDURE

Formal 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.

PROCEDURE

Emergency Department Treatment

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

Sponsors & Collaborators

• Provincial Health Services Authority

  collaborator OTHER

• University of Mississippi Medical Center

  collaborator OTHER

• MultiCare Mary Bridge Children's Hospital & Health Center

  collaborator OTHER

• Yale New Haven Health System Center for Healthcare Solutions

  collaborator OTHER

• University of New Mexico Carrie Tingley Hospital

  collaborator UNKNOWN

• IWK Health Centre

  collaborator OTHER

• Phoenix Children's Hospital

  collaborator OTHER

• Children's Hospital Colorado

  collaborator OTHER

• Nationwide Children's Hospital

  collaborator OTHER

• Morristown Medical Center

  collaborator OTHER

• NYUMC-Hospital for Joint Diseases

  collaborator UNKNOWN

• Children's Medical Center Dallas

  collaborator OTHER

• Johns Hopkins University

  collaborator OTHER

• Orthopaedic Institute for Children

  collaborator OTHER

• Children's Hospital Los Angeles

  collaborator OTHER

• St. Christopher's Hospital for Children

  collaborator OTHER

• Children's Hospital of Orange County

  collaborator OTHER

• Ann & Robert H Lurie Children's Hospital of Chicago

  lead OTHER

Principal Investigators

• Joseph (Jay) A Janicki, MD, MS · Ann & Robert H Lurie Children's Hospital of Chicago

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

3 Years

Max Age

14 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-03-31

Primary Completion

2026-01-31

Completion

2026-06-30

Countries

• United States

Study Locations