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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores better ways to treat minor open fractures in children by comparing two methods: standard surgery in an operating room (formal operative treatment) and a simpler treatment in the emergency room, which involves cleaning, setting the bone, and administering antibiotics at home (emergency department treatment). The goal is to determine if the simpler method is equally safe and effective. Children may qualify if they have a minor fracture from a low-energy accident, such as a fall or a bike crash, and the wound is small and not deep. The trial will assess infection rates and bone healing speed for each method. As an unphased trial, this study provides an opportunity to explore innovative treatment options that could simplify recovery for children.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that treating open fractures in the emergency room lacks well-documented safety data. This method involves cleaning the wound, setting the broken bone, and prescribing antibiotics for home use. Clear information on the safety of this approach is unavailable.

In contrast, studies have shown that surgery is a common and accepted treatment for open fractures. However, approximately 40% of these cases can experience complications, such as infections and other issues.

Both treatments have advantages and disadvantages. Emergency room treatment is less invasive but lacks detailed safety data. Surgery is more established but carries a risk of complications. Considering these factors is important when deciding whether to join a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for open fractures because they offer new approaches to managing these injuries. Unlike standard care, which typically involves immediate surgery for cleaning and repairing the fracture, the Emergency Department Treatment provides immediate washout and closed reduction right in the ER, under conscious sedation, followed by antibiotics at home. This could potentially reduce the need for immediate operative intervention and make recovery more comfortable. On the other hand, the Formal Operative Treatment involves taking the child to the operating room within 24 hours, ensuring thorough cleaning and management of the fracture in a controlled surgical environment. These approaches aim to improve recovery times and patient comfort, potentially transforming how open fractures are treated in emergency settings.

What evidence suggests that this trial's treatments could be effective for open fractures?

This trial compares two treatment approaches for open fractures in children. In the Emergency Department Treatment arm, children receive a washout in the emergency room under conscious sedation, a closed reduction, and home antibiotics. Studies have shown that treating open fractures in the emergency room with antibiotics and simple cleaning can be as effective as more complicated surgeries. Research indicates that taking antibiotics for 24 hours can be as effective as longer courses for all types of open fractures. This quicker approach can also help prevent infections by delivering antibiotics to patients faster.

In the Formal Operative Treatment arm, children go to the Operating Room within 24 hours for irrigation, debridement, and appropriate bone management. Traditionally, surgery has been used to clean and align broken bones properly. Both methods have their advantages, but less aggressive emergency treatments might offer similar results without requiring surgery. ^{1 2 3 5 6}

Who Is on the Research Team?

Joseph (Jay) A Janicki, MD, MS

Principal Investigator

Ann & Robert H Lurie Children's Hospital of Chicago

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10502353/

Management of open fractures: A narrative review - PMC 5.3.​​ Studies have shown non-inferiority of 24 h of antibiotic treatment with a second-generation cephalosporin when compared to 5 days in all grades of open ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0020138325003973

Tracking the prehospital time course of open fracture patients Many patients with open fractures had transfer of care more than one hour after dispatch. FRI was associated with increased prehospital time.

3. researchprotocols.org researchprotocols.org/2024/1/e57820/

Improving the Care of Severe, Open Fractures and ... Studies show that, in approximately 40% of cases, complications occur during the treatment in open fractures [ Outcomes in open tibia fractures ...

4. journals.lww.com journals.lww.com/jbjsoa/fulltext/2024/06000/an_assessment_of_open_fracture_management_in.3.aspx

An Assessment of Open Fracture Management in Hospitals ... There was no significant improvement (p = 0.083) in the percentage who underwent open-fracture debridement before referral, 40% (4) before and 64% (7) after the ...

5. withpower.com withpower.com/trial/phase-fractures-open-2-2010-61ea0

Emergency Department Treatment for Open Fractures A new emergency department protocol for administering antibiotics to patients with open fractures significantly reduced the average time to antibiotic ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12499681/

Factors associated with hospitalization for emergency ... The analysis results showed that 7 variables were statistically associated with hospitalization, including living alone, open fracture status, ...