Clinical trial NCT00870064: The Treatment of Type I Open Fractures in Pediatrics
Official title: The Treatment of Type I Open Fractures in Pediatrics: Evaluating the Necessity of Formal Irrigation and Debridement
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Fractures, Open
Keywords: Surgical Procedures, Operative
Fractures, Open
Fracture Fixation
Lead sponsor: Ann & Robert H Lurie Children's Hospital of Chicago
Sponsor class: OTHER
Collaborators: name: Provincial Health Services Authority
name: University of Mississippi Medical Center
name: MultiCare Mary Bridge Children's Hospital & Health Center
name: Yale New Haven Health System Center for Healthcare Solutions
name: University of New Mexico Carrie Tingley Hospital
name: IWK Health Centre
name: Phoenix Children's Hospital
name: Children's Hospital Colorado
name: Nationwide Children's Hospital
name: Morristown Medical Center
name: NYUMC-Hospital for Joint Diseases
name: Children's Medical Center Dallas
name: Johns Hopkins University
name: Orthopaedic Institute for Children
name: Children's Hospital Los Angeles
name: St. Christopher's Hospital for Children
name: Children's Hospital of Orange County
First posted: 2009-03-26
Enrollment: 300
Sex: ALL
Minimum age (years): 3
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Open fractures are frequently encountered in orthopaedics. Treatment usually calls for a formal, operative procedure in which the bone is exposed, foreign tissue is debrided and the wound is irrigated. While this is the current standard of care, not all open fractures are equal. In retrospective studies, centers are reporting less aggressive operative management for open fractures may result in equal results without the time and expense of the operative theater. The investigators propose a prospective, randomized trial of children with type I open fractures to evaluate whether formal operative treatment is necessary. The investigators' hypothesis is that minor 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. Children who meet the study criteria will be randomized into two treatment arms - formal operative management (OR) and emergency department (ED) management. Outcomes from each group will be evaluated and compared, including rate of infection, number of return visits to the operating room, time to union, and other complications.

Detailed description: Fractures in which bone has been exposed to the outside world through an associated skin injury, known as open fractures, are frequently encountered in orthopaedics. Traditionally, treatment calls for a formal, operative treatment in which the bone is exposed, foreign tissue is debrided and the wound is irrigated. The bone itself, depending on the age of the patient, fracture location and stability is then treated by the appropriate method of casting or internal fixation. However, while this is the current standard of care for all open fractures, not all open fractures are the same and can differ in terms of the bone involved, energy causing the injury and the skeletal maturity of the patient. Children, for example, have a thick periosteum which may diminish the rate of infection and decrease the time to healing. In addition, the protocol of operative debridement was introduced at the same time as widespread antibiotic use. It is not known whether the mechanical operative management or antibiotic use has resulted in improved outcomes. In retrospective studies, centers are reporting emergency department management alone may result in equal results without the time and expense of the operative theater.

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.

Eligibility 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)

Primary outcomes:
measure: Rate of infection
timeFrame: 2 weeks
Secondary outcomes:
measure: Time to bone healing
timeFrame: 24 weeks
measure: Return visits to OR
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Ann & Robert H. Lurie Children's Hospital of Chicago
state: Illinois
Study officials:
affiliation: Ann & Robert H Lurie Children's Hospital of Chicago
name: Joseph (Jay) A Janicki, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Haasbeek JF, Cole WG. Open fractures of the arm in children. J Bone Joint Surg Br. 1995 Jul;77(4):576-81.
citation: 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.
citation: 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.
citation: 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.