Recruiting

Type I Open Fractures

Sponsor:

Ann & Robert H Lurie Children's Hospital of Chicago

Code:

NCT00870064

Conditions

Fractures, Open

Eligibility Criteria

Sex: All

Age: 3 - 14

Healthy Volunteers: Not accepted

Interventions

Formal Operative Treatment

Emergency Department Treatment

Study Details

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.

Conditions

Fractures, Open

Study ID

NCT00870064

Start date

Mar, 2010

Status verified date

Jun, 2026

Completion date

Sep, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 3 - 14

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Formal Operative Treatment

Children randomized to the formal operative management arm will be taken to the Operating Room within 24 hours for irrigation and debridement and appropriate bone management.

other: Emergency Department Treatment

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

Interventions

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.

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.

Primary outcome measure

  • Rate of infection [ Time Frame: 2 weeks ]

Central Contacts and Locations

Central contacts

Locations

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

Recruiting

Chicago, Illinois, United States, 60611

Contacts

More Information

Sponsor

Ann & Robert H Lurie Children's Hospital of Chicago

Last update posted

Jul 1, 2026

Last verified

Jun, 2026

Keywords

  • Surgical Procedures, Operative
  • Fractures, Open
  • Fracture Fixation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Ann & Robert H Lurie Children's Hospital of Chicago on 2026-07-01.