Emergency Department Treatment for Open Fractures
(PROOF Trial)
Recruiting in Palo Alto (17 mi)
Overseen byJoseph (Jay) A Janicki, MD, MS
Age: < 18
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago
Disqualifiers: High energy injury, others
No Placebo Group
Trial Summary
What is the purpose of this trial?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.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment Emergency Department Treatment, Formal Operative Treatment for open fractures?
Research shows that quickly giving antibiotics in the emergency department is crucial for preventing infections in open fractures. This suggests that timely and appropriate treatment in the emergency department can be effective in managing open fractures.
12345Is emergency department treatment for open fractures generally safe for humans?
Research on emergency department treatments shows that adverse events (unintended injuries related to healthcare) can occur, but these studies focus on general emergency care and not specifically on open fractures. While these studies highlight the importance of patient safety, they do not provide specific safety data for emergency treatment of open fractures.
678910How does the Emergency Department Treatment for Open Fractures differ from other treatments?
The Emergency Department Treatment for Open Fractures is unique because it emphasizes the rapid administration of antibiotics to prevent infection, which is crucial in reducing complications. This approach is part of a protocol designed to ensure timely and appropriate antibiotic use, setting it apart from other treatments that may not prioritize this immediate step.
134511Eligibility Criteria
This trial is for children with minor type I open fractures, typically from low-energy injuries like small falls or bike accidents. The wound must be less than 1cm without the bone showing through the skin. It's not for kids with high-energy injuries, larger wounds, grossly contaminated wounds, hand/foot fractures, or those needing surgery to align and fix the bones.Inclusion Criteria
My broken bone can be fixed without surgery.
I was injured in a low-impact accident, like a fall or bike crash.
My wound is smaller than 1cm and the bone isn't visible.
Exclusion Criteria
I have an open fracture in my hand or foot.
I have a wound longer than 1cm.
My wound is severely infected.
+3 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
1-2 weeks
Treatment
Participants are randomized into two treatment arms: formal operative management or emergency department management. Formal operative management involves irrigation and debridement in the operating room, while emergency department management involves washout, closed reduction, and home antibiotics.
2 weeks
1 visit (in-person)
Follow-up
Participants are monitored for infection rates, time to bone healing, and other complications. Wounds are examined at interval follow-up periods.
24 weeks
Multiple visits (in-person)
Participant Groups
The study compares two ways to treat these fractures: traditional surgery (OR) versus simpler emergency room (ED) care involving cleaning the wound and setting the bone without surgery. Kids will be randomly placed in one of these groups to see which method works best regarding infection rates and healing times.
2Treatment groups
Experimental Treatment
Group I: Formal Operative TreatmentExperimental Treatment1 Intervention
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.
Group II: Emergency Department TreatmentExperimental Treatment1 Intervention
Children in the Emergency Department Treatment arm will have a washout in the emergency room under conscious sedation, a closed reduction and home antibiotics.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Ann & Robert H. Lurie Children's Hospital of ChicagoChicago, IL
Loading ...
Who Is Running the Clinical Trial?
Ann & Robert H Lurie Children's Hospital of ChicagoLead Sponsor
Children's Hospital of Orange CountyCollaborator
Provincial Health Services AuthorityCollaborator
University of Mississippi Medical CenterCollaborator
MultiCare Mary Bridge Children's Hospital & Health CenterCollaborator
Yale New Haven Health System Center for Healthcare SolutionsCollaborator
University of New Mexico Carrie Tingley HospitalCollaborator
IWK Health CentreCollaborator
Phoenix Children's HospitalCollaborator
Children's Hospital ColoradoCollaborator
References
Implementation of an Antibiotic Therapy Protocol for Open Fractures in the Emergency Department. [2023]Well established in the Emergency Department (ED) literature is that the most important factor in decreasing subsequent infection rate in open fractures is the time to first administration of antibiotics. As such, the authors developed a new ED open fracture antibiotic protocol to facilitate more expeditious antibiotic administration and appropriate choice of antibiotics.
Open Fractures in Pediatric Orthopaedics-Can Pathways Improve Care? A 1-Year Pre and Postimplementation Analysis. [2023]In the care of open fractures, time to antibiotic administration has been shown to be a critical factor in preventing infection. To help improve outcomes at our institution we designed and implemented an open fracture pathway with the goal of reducing the time from emergency department (ED) arrival to antibiotic administration. Here we evaluate the success of this pathway, propose improvements in the protocol, and provide a framework for initiation at other institutions.
Current management of open fractures: results from an online survey. [2022]Open fractures are orthopaedic emergencies that carry a high risk for infection, non-union and soft tissue complications. Evidence-based treatment is impeded by the lack of high-quality evidence-based studies. The aim of this investigation was to elucidate the current practice of open fracture management in Germany and to determine major differences in treatment.
Management of open fractures. [2010]The management of open fractures is a surgical emergency. This article discusses in detail the primary goals of obtaining fracture healing, preventing infection, and restoring optimum function of the injured extremity.
Management of open fractures. [2022]An open fracture is an orthopaedic emergency that can lead to devastating complications and prolonged rehabilitation. The goals of treatment are to prevent infection, achieve bone union, and restore function. The treatment should involve the use of antibiotics, repeated thorough irrigation and debridement, early fracture stabilization, early wound closure, and aggressive rehabilitation. The result of treatment is largely affected by the initial soft-tissue loss, wound contamination, fracture stability, and neurovascular status.
Adverse events in the paediatric emergency department: a prospective cohort study. [2021]Understanding adverse events among children treated in the emergency department (ED) offers an opportunity to improve patient safety by providing evidence of where to focus efforts in a resource-restricted environment.
Association between waiting times and short term mortality and hospital admission after departure from emergency department: population based cohort study from Ontario, Canada. [2022]To determine whether patients who are not admitted to hospital after attending an emergency department during shifts with long waiting times are at risk for adverse events.
A Review of Adverse Event Reports From Emergency Departments in the Veterans Health Administration. [2023]Previous work assessing the frequency of adverse events in emergency medicine has been limited. The emergency department (ED) provides an initial point of care for millions of patients. Given the volume of patient encounters and the complexity of medical conditions treated in the ED, it is necessary to determine the system-based issues and associated contributing factors impacting patient safety.
Adverse events among patients registered in high-acuity areas of the emergency department: a prospective cohort study. [2022]To enhance patient safety, it is important to understand the frequency and causes of adverse events (defined as unintended injuries related to health care management). We performed this study to describe the types and risk of adverse events in high-acuity areas of the emergency department (ED).
Evaluating adverse drug event reporting in administrative data from emergency departments: a validation study. [2021]Adverse drug events are a frequent cause of emergency department presentations. Administrative data could be used to identify patients presenting with adverse drug events for post-market surveillance, and to conduct research in patient safety and in drug safety and effectiveness. However, such data sources have not been evaluated for their completeness with regard to adverse drug event reporting. Our objective was to determine the proportion of adverse drug events to outpatient medications diagnosed at the point-of-care in emergency departments that were documented in administrative data.
Current Practice in the Management of Type I Open Fractures in Children: A Survey of POSNA Membership. [2018]Treatment of pediatric type I open fractures is controversial. Centers have reported good success with emergency room (ER) treatment of low-energy (type I) open pediatric fractures. The purpose of this study was to ascertain the treatment preferences of pediatric orthopaedic surgeons for type I open fractures. We hypothesize that surgeons will have different treatment protocols and preferred location for these injuries.