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Formal Operative Treatment for Fractures (PROOF Trial)

N/A

Waitlist Available

Led By Joseph (Jay) A Janicki, MD, MS

Research Sponsored by Ann & Robert H Lurie Children's Hospital of Chicago

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 weeks

Awards & highlights

PROOF Trial Summary

This trial is studying whether children with type I 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.

Eligible Conditions

Open Fractures

PROOF Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Communicable Diseases

Secondary outcome measures

Return visits to

Time to bone healing

PROOF Trial Design

2Treatment groups

Experimental Treatment

Group I: Formal Operative TreatmentExperimental Treatment1 Intervention

Children randomized to the formal operative management arm will be taken to the Operating Room within 24 hours for irrigation and debridement and appropriate bone management.

Group II: Emergency Department TreatmentExperimental Treatment1 Intervention

Children in the Emergency Department Treatment arm will have a washout in the emergency room under conscious sedation, a closed reduction and home antibiotics.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Ann & Robert H Lurie Children's Hospital of ChicagoLead Sponsor

258 Previous Clinical Trials

5,188,830 Total Patients Enrolled

Provincial Health Services AuthorityOTHER

39 Previous Clinical Trials

31,295 Total Patients Enrolled

University of Mississippi Medical CenterOTHER

174 Previous Clinical Trials

195,087 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals is this experiment encompassing?

"Correct. Clinicaltrials.gov has the most up-to-date information on this clinical trial, first posted in March 2010 and recently revised August 2021. It is actively recruiting 300 patients from one location."

Answered by AI

Is this experiment enrolling new participants at the present time?

"Affirmative. Information hosted on clinicaltrials.gov demonstrates that the medical trial, initially posted March 1st 2010, is actively seeking participants. 300 volunteers are required to participate at a single location."

Answered by AI

Who meets the criteria for eligibility in this trial?

"This clinical study is accepting 300 participants between the ages of 3 and 14 with open fractures. To qualify for this trial, hopeful candidates must meet these criteria."

Answered by AI

Are geriatric patients eligible for participation in this research?

"This medical trial is open for enrollment to individuals aged 3-14. Furthermore, 67 studies are available for minors and 293 trials accept seniors who meet the criteria."

Answered by AI

Recent research and studies

Archives of SurgeryJournal

Use of Antimicrobials in the Management of Open Fractures

Gustilo, Ramon B.. 1979. “Use of Antimicrobials in the Management of Open Fractures”. Archives of Surgery. American Medical Association (AMA). doi:10.1001/archsurg.1979.01370310047010.

Clinical Orthopaedics & Related ResearchJournal

Treatment of Isolated Type I Open Fractures

Yang, Edward C., and Jesse Eisler. 2003. “Treatment of Isolated Type I Open Fractures”. Clinical Orthopaedics & Related Research. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/01.blo.0000063795.32430.4c.

Osteoporosis InternationalJournal

How Many Children Remain Fracture-free During Growth? A Longitudinal Study of Children and Adolescents Participating in the Dunedin Multidisciplinary Health and Development Study

Jones, I. E., S. M. Williams, N. Dow, and A. Goulding. 2002. “How Many Children Remain Fracture-free During Growth? A Longitudinal Study of Children and Adolescents Participating in the Dunedin Multidisciplinary Health and Development Study”. Osteoporosis International. Springer Science and Business Media LLC. doi:10.1007/s001980200137.

formation/NLM/NIH, NCBI. “Gprobe”. 2017. Web. <https://github.com/ncbi/gprobe>..Journal