The Treatment of Type I Open Fractures in Pediatrics (PROOF)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2015 by Ann & Robert H Lurie Children's Hospital of Chicago
Sponsor:
Collaborators:
Riley Children's Hospital
Provincial Health Services Authority
University of Mississippi Medical Center
Mary Bridge Children's Hospital
Yale-New Haven Children's Hospital
Carrie Tingley Children's Hospital
IWK Health Centre
Phoenix Children's Hospital
Texas Children's Hospital
Children's Hospital Colorado
Nationwide Children's Hospital
Morristown Medical Center
NYUMC-Hospital for Joint Diseases
Children's Medical Center Dallas
Carolinas Healthcare System
Pediatric Orthopaedic Society of North America (POSNA)
Johns Hopkins University
Orthopaedic Institute for Children
Children's Hospital Los Angeles
Information provided by (Responsible Party):
Joseph Janicki, Ann & Robert H Lurie Children's Hospital of Chicago
ClinicalTrials.gov Identifier:
NCT00870064
First received: March 25, 2009
Last updated: July 29, 2015
Last verified: July 2015

March 25, 2009
July 29, 2015
March 2010
October 2018   (final data collection date for primary outcome measure)
Rate of infection [ Time Frame: 1, 2, 4, 6, 12, 24 weeks ] [ Designated as safety issue: No ]
1. Do patients with type one open fractures treated in the emergency department with irrigation have a non-inferior rate of infections compared to those treated in the operating room with formal irrigation and debridement? The response variable will be the presence of an infection in children with open fractures.
Rate of infection [ Time Frame: 1, 2, 4, 6, 12, 24 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00870064 on ClinicalTrials.gov Archive Site
  • Time to bone healing [ Time Frame: 1, 2, 4, 6, 12, 24 weeks ] [ Designated as safety issue: No ]
    2. Do patients with type I open fractures who are treated nonoperatively have a non-inferior time to bone healing when compared to those treated operatively? The response variable will be time to clinical and radiographic fracture healing.
  • Number of return visits to OR [ Time Frame: 1, 2, 4, 6, 12, 24 weeks ] [ Designated as safety issue: No ]
  • Time to bone healing [ Time Frame: 1, 2, 4, 6, 12, 24 weeks ] [ Designated as safety issue: No ]
  • Number of return visits to OR [ Time Frame: 1, 2, 4, 6, 12, 24 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
The Treatment of Type I Open Fractures in Pediatrics
The Treatment of Type I Open Fractures in Pediatrics: Evaluating the Necessity of Formal Irrigation and Debridement

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.

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.

We propose a prospective, randomized trial of children with type I open fractures to evaluate whether formal operative treatment is necessary. Our hypothesis is 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.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Fractures, Open
  • Procedure: 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.
  • Procedure: 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.
  • Formal Operative Management
    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.
    Intervention: Procedure: Formal Operative Treatment
  • 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.
    Intervention: Procedure: Emergency Department Treatment

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
300
October 2018
October 2018   (final data collection date for primary outcome measure)

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)
Both
3 Years to 14 Years
No
Contact: Jamie K Burgess, PhD, CCRP 312-227-6531 jburgess@luriechildrens.org
Contact: Sarah A Goldberg, BA, CCRP 312-227-6627 sgoldberg@luriechildrens.org
United States
 
NCT00870064
2009-13763
No
Joseph Janicki, Ann & Robert H Lurie Children's Hospital of Chicago
Ann & Robert H Lurie Children's Hospital of Chicago
  • Riley Children's Hospital
  • Provincial Health Services Authority
  • University of Mississippi Medical Center
  • Mary Bridge Children's Hospital
  • Yale-New Haven Children's Hospital
  • Carrie Tingley Children's Hospital
  • IWK Health Centre
  • Phoenix Children's Hospital
  • Texas Children's Hospital
  • Children's Hospital Colorado
  • Nationwide Children's Hospital
  • Morristown Medical Center
  • NYUMC-Hospital for Joint Diseases
  • Children's Medical Center Dallas
  • Carolinas Healthcare System
  • Pediatric Orthopaedic Society of North America (POSNA)
  • Johns Hopkins University
  • Orthopaedic Institute for Children
  • Children's Hospital Los Angeles
Principal Investigator: Joseph (Jay) A Janicki, MD, MS Ann & Robert H Lurie Children's Hospital of Chicago
Ann & Robert H Lurie Children's Hospital of Chicago
July 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP