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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: Recruiting NA study of Fractures, Open, sponsored by Ann & Robert H Lurie Children's Hospital of Chicago.

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

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.

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

FieldValue
Enrollment Target 300 participants
Start Date 2010-03
Est. Completion 2026-06
Phase NA

What NCT00870064 shows while recruiting

NCT00870064 is an interventional study that assigns participants to a tested intervention. The registered 300 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 293-participant average among 3 other Fractures, Open trials with a reported enrollment target.

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 a single indexed study location in 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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Source: ClinicalTrials.gov NCT00870064, the US trial registry maintained by the National Library of Medicine. NCT00870064 (mid enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.