Evaluating treatment options for type I open fractures in children
The Treatment of Type I Open Fractures in Pediatrics: Evaluating the Necessity of Formal Irrigation and Debridement
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 3 Years to 14 Years |
| Sex | All |
| Sponsor | Ann & Robert H Lurie Children's Hospital of Chicago Academic / other |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT00870064 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with open fractures that require surgical intervention or those with high-energy injuries will not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Chicago, Illinois
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.