The Treatment of Type I Open Fractures in Pediatrics

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Ann & Robert H Lurie Children's Hospital of Chicago
Sponsor:
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: January 28, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Fractures, Open
Procedure: Formal Operative Treatment
Procedure: Emergency Department Treatment
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Treatment of Type I Open Fractures in Pediatrics: Evaluating the Necessity of Formal Irrigation and Debridement

Resource links provided by NLM:


Further study details as provided by Ann & Robert H Lurie Children's Hospital of Chicago:

Primary Outcome Measures:
  • Rate of infection [ Time Frame: 1, 2, 4, 6, 12, 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 200
Study Start Date: March 2010
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
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.
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.

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.

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.

  Eligibility

Ages Eligible for Study:   3 Years to 14 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • open fracture amenable to treatment by closed reduction
  • low energy mechanism of injury
  • wound less than 1cm in length

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
  • wound greater than 1cm in length
  • gross contamination of wound
  • open fractures involving hands or feet
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00870064

Contacts
Contact: Joseph (Jay) A Janicki, MD 773-327-5382 jjanicki@luriechildrens.org
Contact: Joe Grissom, MPP, CCRP 773-327-1241 jgrissom@luriechildrens.org

Locations
United States, Illinois
Ann & Robert H Lurie Children's Hospital of Chicago Recruiting
Chicago, Illinois, United States, 60611
Contact: Joseph (Jay) A Janicki, MD    773-327-5382    jjanicki@luriechildrens.org   
Contact: Joe Grissom, MPP, CCRP    773-327-1241    jgrissom@luriechildrens.org   
Sponsors and Collaborators
Ann & Robert H Lurie Children's Hospital of Chicago
Investigators
Principal Investigator: Joseph (Jay) A Janicki, MD Ann & Robert H Lurie Children's Hospital of Chicago
  More Information

Publications:
Responsible Party: Joseph Janicki, MD, Assistant Professor of Pediatics, NU Feinberg School of Medicine, Ann & Robert H Lurie Children's Hospital of Chicago
ClinicalTrials.gov Identifier: NCT00870064     History of Changes
Other Study ID Numbers: 2009-13763
Study First Received: March 25, 2009
Last Updated: January 28, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Ann & Robert H Lurie Children's Hospital of Chicago:
Surgical Procedures, Operative
Fractures, Open
Fracture Fixation

Additional relevant MeSH terms:
Fractures, Bone
Fractures, Open
Wounds and Injuries

ClinicalTrials.gov processed this record on August 21, 2014