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Could a simple ER washout replace surgery for Kids' minor open fractures?

NCT ID NCT00870064

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 01, 2026 · Last updated Jul 02, 2026 · Updated 1 time

Summary

This trial investigates whether children with minor open fractures (type I) can be treated safely in the emergency room with irrigation, closed reduction, and antibiotics, instead of undergoing formal surgery in the operating room. The study enrolls 300 children with low-energy fractures and wounds smaller than 1 cm. Researchers will compare infection rates, bone healing time, and other complications between the two approaches to see if the less invasive method is just as effective.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Formal operative treatment vs. emergency department treatment
What this could lead to
If successful, this could show that many children with minor open fractures can be safely treated in the emergency room, avoiding the need for surgery and its associated costs and risks.
What could go wrong
This is a single trial with 300 children, and results may not apply to all fracture types or more severe injuries. There is a small risk that the emergency room approach could lead to higher infection rates or slower healing.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 300 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2010

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

3 to 14 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

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Conditions

The condition(s) this trial relates to.

Fractures, Open

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

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

    RECRUITING

    Chicago, Illinois, 60611, United States

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