Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
300 participants
INTERVENTIONAL
2010-03-31
2026-06-30
Brief Summary
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Detailed Description
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The investigators propose a prospective, randomized trial of children with type I open fractures to evaluate whether formal operative treatment is necessary. The investigators hypothesize that minor open fractures in children can be safely treated in the emergency room with irrigation, closed reduction and home antibiotics without an increased risk of infection or other complications. If the inclusion criteria is met and informed consent is obtained, children will be randomized into two treatment arms - formal operative management (OR) and emergency department (ED) management. Children randomized to the OR arm will be taken to the OR within 24 hours for irrigation and debridement and appropriate bone management. Children in the ED arm will have a washout in the emergency room under conscious sedation, a closed reduction and home antibiotics. Both wounds will be examined at interval follow up periods for signs of infection. Outcomes evaluated will include the rate of infection, the number of return visits to the operating room, the time to bone healing, and other complications. This is a pilot study with the plan of eventually being a multicenter study evaluating open fracture care in children.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Formal Operative Treatment
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.
Formal Operative Treatment
Children randomized to the OR arm will be taken to the OR within 24 hours for irrigation and debridement and appropriate bone management.
Emergency Department Treatment
Children in the Emergency Department Treatment arm will have a washout in the emergency room under conscious sedation, a closed reduction and home antibiotics.
Emergency Department Treatment
Children in the ED arm will have a washout in the emergency room under conscious sedation, a closed reduction and home antibiotics.
Interventions
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Formal Operative Treatment
Children randomized to the OR arm will be taken to the OR within 24 hours for irrigation and debridement and appropriate bone management.
Emergency Department Treatment
Children in the ED arm will have a washout in the emergency room under conscious sedation, a closed reduction and home antibiotics.
Eligibility Criteria
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Inclusion Criteria
* 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 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)
3 Years
14 Years
ALL
No
Sponsors
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Provincial Health Services Authority
OTHER
University of Mississippi Medical Center
OTHER
MultiCare Mary Bridge Children's Hospital & Health Center
OTHER
Yale New Haven Health System Center for Healthcare Solutions
OTHER
University of New Mexico Carrie Tingley Hospital
UNKNOWN
IWK Health Centre
OTHER
Phoenix Children's Hospital
OTHER
Children's Hospital Colorado
OTHER
Nationwide Children's Hospital
OTHER
Morristown Medical Center
OTHER
NYUMC-Hospital for Joint Diseases
UNKNOWN
Children's Medical Center Dallas
OTHER
Johns Hopkins University
OTHER
Orthopaedic Institute for Children
OTHER
Children's Hospital Los Angeles
OTHER
St. Christopher's Hospital for Children
OTHER
Children's Hospital of Orange County
OTHER
Ann & Robert H Lurie Children's Hospital of Chicago
OTHER
Responsible Party
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Joseph Janicki
MD, Assistant Professor of Pediatrics, Northwestern University Feinberg School of Medicine
Principal Investigators
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Joseph (Jay) A Janicki, MD, MS
Role: PRINCIPAL_INVESTIGATOR
Ann & Robert H Lurie Children's Hospital of Chicago
Locations
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Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Yang EC, Eisler J. Treatment of isolated type I open fractures: is emergent operative debridement necessary? Clin Orthop Relat Res. 2003 May;(410):289-94. doi: 10.1097/01.blo.0000063795.32430.4c.
Iobst CA, Tidwell MA, King WF. Nonoperative management of pediatric type I open fractures. J Pediatr Orthop. 2005 Jul-Aug;25(4):513-7. doi: 10.1097/01.bpo.0000158779.45226.74.
Doak J, Ferrick M. Nonoperative management of pediatric grade 1 open fractures with less than a 24-hour admission. J Pediatr Orthop. 2009 Jan-Feb;29(1):49-51. doi: 10.1097/BPO.0b013e3181901c66.
Gustilo RB, Anderson JT. Prevention of infection in the treatment of one thousand and twenty-five open fractures of long bones: retrospective and prospective analyses. J Bone Joint Surg Am. 1976 Jun;58(4):453-8.
Grimard G, Naudie D, Laberge LC, Hamdy RC. Open fractures of the tibia in children. Clin Orthop Relat Res. 1996 Nov;(332):62-70. doi: 10.1097/00003086-199611000-00009.
Haasbeek JF, Cole WG. Open fractures of the arm in children. J Bone Joint Surg Br. 1995 Jul;77(4):576-81.
Skaggs DL, Kautz SM, Kay RM, Tolo VT. Effect of delay of surgical treatment on rate of infection in open fractures in children. J Pediatr Orthop. 2000 Jan-Feb;20(1):19-22.
Jones BG, Duncan RD. Open tibial fractures in children under 13 years of age--10 years experience. Injury. 2003 Oct;34(10):776-80. doi: 10.1016/s0020-1383(03)00031-7.
Jones IE, Williams SM, Dow N, Goulding A. How many children remain fracture-free during growth? a longitudinal study of children and adolescents participating in the Dunedin Multidisciplinary Health and Development Study. Osteoporos Int. 2002 Dec;13(12):990-5. doi: 10.1007/s001980200137.
Related Links
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Center for Disease Control. (12 April 2024). Surgical Site Infection. In Center for Disease Control and Prevention. Retrieved August 28, 2024
Other Identifiers
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2012-13763
Identifier Type: -
Identifier Source: org_study_id
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