Emergency Department Treatment for Open Fractures

(PROOF Trial)

Overseen By Candace C Young, BS

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago

Disqualifiers: High energy injury, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 2 weeks

300 Participants Needed

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. ^{1 2 3 4 5}

Is 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. ^{6 7 8 9 10}

How 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. ^{1 3 4 5 11}

Research Team

Joseph (Jay) A Janicki, MD, MS

Principal Investigator

Ann & Robert H Lurie Children's Hospital of Chicago

Eligibility 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.

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)

Treatment Details

Interventions

• Emergency Department Treatment
• Formal Operative Treatment

Trial Overview 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.

Participant Groups

Group I: Formal Operative Treatment Experimental Treatment 1 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 Treatment Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Ann & Robert H Lurie Children's Hospital of Chicago

Lead Sponsor

Trials

275

Recruited

5,182,000+

Children's Hospital of Orange County

Collaborator

Trials

38

Recruited

5,700+

Provincial Health Services Authority

Collaborator

Trials

40

Recruited

31,900+

University of Mississippi Medical Center

Collaborator

Trials

185

Recruited

200,000+

MultiCare Mary Bridge Children's Hospital & Health Center

Collaborator

Trials

3

Recruited

840+

Yale New Haven Health System Center for Healthcare Solutions

Collaborator

Trials

6

Recruited

5,600+

University of New Mexico Carrie Tingley Hospital

Collaborator

Trials

1

Recruited

300+

IWK Health Centre

Collaborator

Trials

131

Recruited

112,000+

Phoenix Children's Hospital

Collaborator

Trials

78

Recruited

5,014,000+

Children's Hospital Colorado

Collaborator

Trials

121

Recruited

5,135,000+

Findings from Research

A new emergency department protocol for administering antibiotics to patients with open fractures significantly reduced the average time to antibiotic initiation from 0.907 hours to 0.568 hours, which is crucial for lowering infection rates.

The protocol also improved the average time to definitive treatment in the operating room from 6.63 hours to 3.97 hours, demonstrating that structured guidelines can enhance patient care and outcomes in emergency settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of an Antibiotic Therapy Protocol for Open Fractures in the Emergency Department. Endres, T., Danielson, K., O'Neil, S., et al.[2023]

The implementation of an open fracture pathway significantly reduced the time from emergency department arrival to antibiotic administration for pediatric patients, decreasing the average time from 163.3 minutes to 99.2 minutes.

The percentage of patients receiving antibiotics before transfer increased from 60.5% to 90.0% after the pathway was implemented, indicating improved pre-hospital care and potentially better outcomes in preventing infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Open Fractures in Pediatric Orthopaedics-Can Pathways Improve Care? A 1-Year Pre and Postimplementation Analysis. Makarewich, CA., McNeely, LW., Gohel, S., et al.[2023]

A survey of 653 surgeons in Germany revealed significant variability in the management of open fractures, with only 55% reporting a standard operating procedure for treatment, highlighting a need for more consistent practices.

The preferred treatment methods varied by fracture type, with 61% favoring internal osteosynthesis for Gustilo type I fractures, while temporary external fixation was preferred for more severe types (74% for type II and 93% for type III), indicating differing approaches to stabilization based on fracture severity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current management of open fractures: results from an online survey. Gümbel, D., Matthes, G., Napp, M., et al.[2022]

Open fractures require immediate surgical intervention to ensure proper management and care.

The main objectives in treating open fractures are to achieve effective healing, prevent infections, and restore the best possible function to the affected limb.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of open fractures. Karlin, JM.[2010]

Open fractures are serious orthopedic emergencies that require immediate treatment to prevent complications, including infection and prolonged recovery.

Effective management involves a combination of antibiotics, thorough cleaning of the wound, early stabilization of the fracture, and prompt rehabilitation, with outcomes heavily influenced by factors like soft-tissue damage and wound cleanliness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of open fractures. O'Meara, PM.[2022]

In a study of 1367 children treated in a pediatric emergency department, 2.5% experienced adverse events related to their care, highlighting a significant risk of harm in this setting.

Most of these adverse events (87.9%) were deemed preventable, with management and diagnostic issues being the most common types, indicating areas where patient safety can be improved.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events in the paediatric emergency department: a prospective cohort study. Plint, AC., Stang, A., Newton, AS., et al.[2021]

Patients who visit emergency departments during times of long waiting periods face a higher risk of adverse events, such as hospital admission or death, particularly if they are high acuity patients.

However, patients who leave the emergency department without being seen do not show an increased risk of short-term adverse events, suggesting that their decision to leave may not be harmful.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association between waiting times and short term mortality and hospital admission after departure from emergency department: population based cohort study from Ontario, Canada. Guttmann, A., Schull, MJ., Vermeulen, MJ., et al.[2022]

A retrospective analysis of 144 adverse events in Veterans Health Administration emergency departments revealed that the most common issues included delays in care (26.4%), elopements (14.6%), and suicide attempts (10.4%).

The primary root causes identified were knowledge deficits (11.4%), inadequate policies and procedures (11.1%), and a lack of standardized practices (9.4%), highlighting areas for improvement to enhance patient safety in emergency care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Review of Adverse Event Reports From Emergency Departments in the Veterans Health Administration. Gill, S., Mills, PD., Watts, BV., et al.[2023]

In a study of 503 patients treated in high-acuity areas of two emergency departments, 8.5% were found to have experienced adverse events, with over half of these events (55.8%) deemed preventable.

The most common types of adverse events included management issues, procedural complications, and diagnostic errors, highlighting the need for improved safety measures in emergency care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events among patients registered in high-acuity areas of the emergency department: a prospective cohort study. Calder, LA., Forster, A., Nelson, M., et al.[2022]

In a study of 1574 emergency department visits, only 6.8% of adverse drug events (ADEs) diagnosed at the point-of-care were documented in administrative data, highlighting significant underreporting.

When broadening the criteria for identifying ADEs in administrative records, the sensitivity increased to 28.1%, indicating that many adverse events may still go unrecorded, which could impact patient safety monitoring and drug effectiveness research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating adverse drug event reporting in administrative data from emergency departments: a validation study. Hohl, CM., Kuramoto, L., Yu, E., et al.[2021]

A survey of 181 pediatric orthopedic surgeons revealed significant variability in treatment preferences for type I open fractures, with many favoring emergency room (ER) treatment over traditional operating room (OR) management.

Despite the lack of consensus on irrigation techniques and antibiotic use, a majority of surgeons (92%) indicated they would change their practices if level 1 evidence showed equivalent outcomes between ER and OR treatments, highlighting the need for further research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current Practice in the Management of Type I Open Fractures in Children: A Survey of POSNA Membership. Wetzel, RJ., Minhas, SV., Patrick, BC., et al.[2018]

References

1. United States pubmed.ncbi.nlm.nih.gov

Implementation of an Antibiotic Therapy Protocol for Open Fractures in the Emergency Department. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Open Fractures in Pediatric Orthopaedics-Can Pathways Improve Care? A 1-Year Pre and Postimplementation Analysis. [2023]

3. Germany pubmed.ncbi.nlm.nih.gov

Current management of open fractures: results from an online survey. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Management of open fractures. [2010]

5. United States pubmed.ncbi.nlm.nih.gov

Management of open fractures. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Adverse events in the paediatric emergency department: a prospective cohort study. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Association between waiting times and short term mortality and hospital admission after departure from emergency department: population based cohort study from Ontario, Canada. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

A Review of Adverse Event Reports From Emergency Departments in the Veterans Health Administration. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Adverse events among patients registered in high-acuity areas of the emergency department: a prospective cohort study. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Evaluating adverse drug event reporting in administrative data from emergency departments: a validation study. [2021]

11. United States pubmed.ncbi.nlm.nih.gov

Current Practice in the Management of Type I Open Fractures in Children: A Survey of POSNA Membership. [2018]