RECRUITING

The Treatment of Type I Open Fractures in Pediatrics

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2010-03
Study Completion:2025-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT00870064

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:3 Years to 14 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * open fracture amenable to treatment by closed reduction
  2. * low energy mechanism of injury (e.g., falls from less than 10 feet, bicycle accidents)
  3. * wound less than 1cm in length and the bone not visualized through the skin
  1. * open fracture not amenable to treatment by closed reduction
  2. * open fracture that would typically require operative reduction and fixation
  3. * high energy mechanism of injury (e.g., struck by vehicle, motor vehicle accidents, fall from height greater than 10 feet)
  4. * wound greater than 1cm in length
  5. * gross contamination of wound
  6. * open fractures involving hands or feet (the current standard of care to treat open injuries involving hands or feet is only emergency room management)

Contacts and Locations

Study Contact

Jamie K Burgess, PhD, CCRP
CONTACT
312-227-6531
jburgess@luriechildrens.org
Candace C Young, BS
CONTACT
312-227-6427
cayoung@luriechildrens.org

Principal Investigator

Joseph (Jay) A Janicki, MD, MS
PRINCIPAL_INVESTIGATOR
Ann & Robert H Lurie Children's Hospital of Chicago

Study Locations (Sites)

Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
United States

Collaborators and Investigators

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

  • Joseph (Jay) A Janicki, MD, MS, PRINCIPAL_INVESTIGATOR, Ann & Robert H Lurie Children's Hospital of Chicago

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2010-03
Study Completion Date2025-12

Study Record Updates

Study Start Date2010-03
Study Completion Date2025-12

Terms related to this study

Keywords Provided by Researchers

  • Surgical Procedures, Operative
  • Fractures, Open
  • Fracture Fixation

Additional Relevant MeSH Terms

  • Fractures, Open