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NCT00870064 · ClinicalTrials.gov registry record · NA
The Treatment of Type I Open Fractures in Pediatrics
A NA study of Fractures, Open, sponsored by Ann & Robert H Lurie Children's Hospital of Chicago.
- Recruiting
- Registry status
- NA
- Development phase
- 300
- Enrollment target
- 1
- Study location
NCT00870064 is a NA study of Fractures, Open that is actively recruiting participants, run by Ann & Robert H Lurie Children's Hospital of Chicago. The registered enrollment target is 300 participants, roughly in line with the 293-participant average among 3 other Fractures, Open trials with a reported enrollment target. The trial reports 1 study location across 1 state.
The verdict
NCT00870064, a NA study of Fractures, Open, is actively recruiting participants, sponsored by Ann & Robert H Lurie Children's Hospital of Chicago.
- RECRUITING
- Registry status
- NA
- Development phase
- 300 participants
- Enrollment target
- 1
- Study location
Study 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 Studied
Interventions
- PROCEDURE Formal Operative Treatment
- PROCEDURE Emergency Department Treatment
Study Locations (1)
Illinois
- Ann & Robert H. Lurie Children's Hospital of Chicago - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2010-03 |
| Est. Completion | 2026-06 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00870064
The ClinicalTrials.gov registry entry for NCT00870064 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 300 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 293-participant average among 3 other Fractures, Open trials with a reported enrollment target. The listed sponsor is Ann & Robert H Lurie Children's Hospital of Chicago, which has 159 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Fractures, Open appearing as the primary indexed condition, and to 2 interventions - of which Formal Operative Treatment is the first listed.
NCT00870064 reports 1 study location spanning 1 distinct geographic area - top geographies include Illinois.
Frequently Asked Questions
What is clinical trial NCT00870064 about?
NCT00870064 is a clinical study titled "The Treatment of Type I Open Fractures in Pediatrics". 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 stu...
What is the current status of trial NCT00870064?
This trial is currently recruiting. It is a NA study. The enrollment target is 300 participants. The study started on 2010-03. Estimated completion is 2026-06.
What conditions does trial NCT00870064 study?
This clinical trial studies the following conditions: Fractures, Open.
What interventions are being tested in trial NCT00870064?
The interventions under investigation include: Formal Operative Treatment (PROCEDURE), Emergency Department Treatment (PROCEDURE).
Who is sponsoring clinical trial NCT00870064?
This trial is sponsored by Ann & Robert H Lurie Children's Hospital of Chicago, which has 159 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00870064 being conducted?
This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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