The Treatment of Type I Open Fractures in Pediatrics (PROOF)
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|ClinicalTrials.gov Identifier: NCT00870064|
Recruitment Status : Recruiting
First Posted : March 26, 2009
Last Update Posted : December 29, 2017
|Condition or disease||Intervention/treatment||Phase|
|Fractures, Open||Procedure: Formal Operative Treatment Procedure: Emergency Department Treatment||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Treatment of Type I Open Fractures in Pediatrics: Evaluating the Necessity of Formal Irrigation and Debridement|
|Actual Study Start Date :||March 2010|
|Estimated Primary Completion Date :||October 2018|
|Estimated Study Completion Date :||October 2018|
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.
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.
- Rate of infection [ Time Frame: 1, 2, 4, 6, 12, 24 weeks ]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.
- Time to bone healing [ Time Frame: 1, 2, 4, 6, 12, 24 weeks ]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.
- Return visits to OR [ Time Frame: 1, 2, 4, 6, 12, 24 weeks ]Number of return visits to the operating room
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00870064
|Contact: Jamie K Burgess, PhD, CCRPfirstname.lastname@example.org|
|Contact: Carly A Strohbach, BAemail@example.com|
|United States, Illinois|
|Ann & Robert H. Lurie Children's Hospital of Chicago||Recruiting|
|Chicago, Illinois, United States, 60611|
|Contact: Joseph (Jay) A Janicki, MD, MS 312-227-6194 firstname.lastname@example.org|
|Contact: Carly A Strohbach, BA 312-227-6627 email@example.com|
|Principal Investigator:||Joseph (Jay) A Janicki, MD, MS||Ann & Robert H Lurie Children's Hospital of Chicago|