Evaluating treatment options for type I open fractures in children
Official title: The Treatment of Type I Open Fractures in Pediatrics: Evaluating the Necessity of Formal Irrigation and Debridement
Run by Ann & Robert H Lurie Children's Hospital of Chicago · NCT00870064 · Data updated 2026-11-12
This study tests if children with type I open fractures can be treated safely in the emergency room without surgery, comparing this approach to the usual surgical treatment.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 3 Years to 14 Years |
| Sex | All |
| Enrollment | 300 (estimated) |
| Sponsor | Ann & Robert H Lurie Children's Hospital of Chicago Academic / other |
| Locations | 1 site (Chicago, Illinois) |
| Status | Recruiting |
| Started | March 2010 |
| Main results expected | June 2027 |
| Study ends | September 2027 |
| Registry record updated | July 1, 2026 |
| Trial ID | NCT00870064 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are children with type I open fractures resulting from low-energy injuries, with wounds less than 1cm in length.
✕Probably not a fit
Patients with open fractures that require surgical intervention or those with high-energy injuries will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial investigates whether children with type I open fractures can be effectively treated in the emergency department without formal surgery. The study compares two treatment approaches: traditional operative management and emergency department management involving irrigation, closed reduction, and home antibiotics. By randomizing participants into these two groups, the researchers aim to determine if less invasive treatment can yield similar outcomes to standard surgical procedures. The hypothesis is that minor open fractures can be safely managed without the need for surgery, potentially reducing healthcare costs and patient recovery time.
Why it matters
Potential benefit: If successful, this study could lead to less invasive treatment options for children with type I open fractures, minimizing the need for surgery.
How similar studies have gone: Other studies have suggested that less aggressive management of open fractures may yield comparable outcomes, indicating that this approach is promising but still requires further validation.
Who can join: the full rules
Show full inclusion / exclusion criteria
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)
Where it's running
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Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States Recruiting
Study contacts
- Principal investigator: Joseph (Jay) A Janicki, MD, MS — Ann & Robert H Lurie Children's Hospital of Chicago
- Study coordinator: Jamie K Burgess, PhD, CCRP
- Email: jburgess@luriechildrens.org
- Phone: 312-227-6531
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.