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RECRUITING
NCT00870064
NA

The Treatment of Type I Open Fractures in Pediatrics

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

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

3 Years - 14 Years

Study Type

INTERVENTIONAL

Enrollment

300

Start Date

2010-03

Completion Date

2026-06

Last Updated

2025-06-29

Healthy Volunteers

No

Conditions

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.

Locations (1)

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

Chicago, Illinois, United States