Skip to content

The Treatment of Type I Open Fractures in Pediatrics

The Treatment of Type I Open Fractures in Pediatrics: Evaluating the Necessity of Formal Irrigation and Debridement

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00870064
Acronym
PROOF
Enrollment
300
Registered
2009-03-26
Start date
2010-03-01
Completion date
2027-09-01
Last updated
2026-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fractures, Open

Keywords

Surgical Procedures, Operative, Fractures, Open, Fracture Fixation

Brief summary

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.

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. The investigators propose a prospective, randomized trial of children with type I open fractures to evaluate whether formal operative treatment is necessary. The investigators hypothesize 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.

Interventions

PROCEDUREFormal 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.

PROCEDUREEmergency Department Treatment

Children in the ED arm will have a washout in the emergency room under conscious sedation, a closed reduction and home antibiotics.

Sponsors

Ann & Robert H Lurie Children's Hospital of Chicago
Lead SponsorOTHER
Provincial Health Services Authority British Columbia
CollaboratorOTHER
University of Mississippi Medical Center
CollaboratorOTHER
MultiCare Mary Bridge Children's Hospital & Health Center
CollaboratorOTHER
Yale New Haven Health System Center for Healthcare Solutions
CollaboratorOTHER
University of New Mexico Carrie Tingley Hospital
CollaboratorUNKNOWN
IWK Health Centre
CollaboratorOTHER
Phoenix Children's Hospital
CollaboratorOTHER
Children's Hospital Colorado
CollaboratorOTHER
Nationwide Children's Hospital
CollaboratorOTHER
Morristown Medical Center
CollaboratorOTHER
NYUMC-Hospital for Joint Diseases
CollaboratorUNKNOWN
Children's Medical Center Dallas
CollaboratorOTHER
Johns Hopkins University
CollaboratorOTHER
Orthopaedic Institute for Children
CollaboratorOTHER
Children's Hospital Los Angeles
CollaboratorOTHER
St. Christopher's Hospital for Children
CollaboratorOTHER
Children's Hospital of Orange County
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
3 Years to 14 Years
Healthy volunteers
No

Inclusion criteria

* open fracture amenable to treatment by closed reduction * low energy mechanism of injury (e.g., falls from less than 10 feet, bicycle accidents) * wound less than 1cm in length and the bone not visualized through the skin

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 (e.g., struck by vehicle, motor vehicle accidents, fall from height greater than 10 feet) * wound greater than 1cm in length * gross contamination of wound * open fractures involving hands or feet (the current standard of care to treat open injuries involving hands or feet is only emergency room management)

Design outcomes

Primary

MeasureTime frameDescription
Rate of infection2 weeks1\. 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.

Secondary

MeasureTime frameDescription
Time to bone healing24 weeks2\. 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 OR24 weeksNumber of return visits to the operating room

Countries

United States

Contacts

CONTACTJamie K Burgess, PhD, CCRP
jburgess@luriechildrens.org312-227-6531
CONTACTMichelle S Adzido, MA
madzido@luriechildrens.org312-227-2492
PRINCIPAL_INVESTIGATORJoseph (Jay) A Janicki, MD, MS

Ann & Robert H Lurie Children's Hospital of Chicago

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 2, 2026