NCT00870064

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
1mo left

Started Mar 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 25, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 26, 2009

Completed
11 months until next milestone

Study Start

First participant enrolled

March 1, 2010

Completed
15.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Expected
Last Updated

June 29, 2025

Status Verified

January 1, 2025

Enrollment Period

15.8 years

First QC Date

March 25, 2009

Last Update Submit

June 25, 2025

Conditions

Fractures, Open

Keywords

Surgical Procedures, OperativeFractures, OpenFracture Fixation

Outcome Measures

Primary Outcomes (1)

  • Rate of infection

    1\. 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.

    2 weeks

Secondary Outcomes (2)

  • Time to bone healing

    24 weeks

  • Return visits to OR

    24 weeks

Study Arms (2)

Formal Operative Treatment

OTHER

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.

Procedure: Formal Operative Treatment

Emergency Department Treatment

OTHER

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

Procedure: Emergency Department Treatment

Interventions

Formal Operative TreatmentPROCEDURE

Children randomized to the OR arm will be taken to the OR within 24 hours for irrigation and debridement and appropriate bone management.

Formal Operative Treatment
Emergency Department TreatmentPROCEDURE

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

Emergency Department Treatment

Eligibility Criteria

Age3 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, 60611, United States

RECRUITING

Related Publications (9)

  • Yang EC, Eisler J. Treatment of isolated type I open fractures: is emergent operative debridement necessary? Clin Orthop Relat Res. 2003 May;(410):289-94. doi: 10.1097/01.blo.0000063795.32430.4c.

    PMID: 12771843BACKGROUND

  • Iobst CA, Tidwell MA, King WF. Nonoperative management of pediatric type I open fractures. J Pediatr Orthop. 2005 Jul-Aug;25(4):513-7. doi: 10.1097/01.bpo.0000158779.45226.74.

    PMID: 15958906BACKGROUND

  • Doak J, Ferrick M. Nonoperative management of pediatric grade 1 open fractures with less than a 24-hour admission. J Pediatr Orthop. 2009 Jan-Feb;29(1):49-51. doi: 10.1097/BPO.0b013e3181901c66.

    PMID: 19098646BACKGROUND

  • Gustilo RB, Anderson JT. Prevention of infection in the treatment of one thousand and twenty-five open fractures of long bones: retrospective and prospective analyses. J Bone Joint Surg Am. 1976 Jun;58(4):453-8.

    PMID: 773941BACKGROUND

  • Grimard G, Naudie D, Laberge LC, Hamdy RC. Open fractures of the tibia in children. Clin Orthop Relat Res. 1996 Nov;(332):62-70. doi: 10.1097/00003086-199611000-00009.

    PMID: 8913146BACKGROUND

  • Haasbeek JF, Cole WG. Open fractures of the arm in children. J Bone Joint Surg Br. 1995 Jul;77(4):576-81.

    PMID: 7615601BACKGROUND

  • Skaggs DL, Kautz SM, Kay RM, Tolo VT. Effect of delay of surgical treatment on rate of infection in open fractures in children. J Pediatr Orthop. 2000 Jan-Feb;20(1):19-22.

    PMID: 10641682BACKGROUND

  • Jones BG, Duncan RD. Open tibial fractures in children under 13 years of age--10 years experience. Injury. 2003 Oct;34(10):776-80. doi: 10.1016/s0020-1383(03)00031-7.

    PMID: 14519359BACKGROUND

  • Jones IE, Williams SM, Dow N, Goulding A. How many children remain fracture-free during growth? a longitudinal study of children and adolescents participating in the Dunedin Multidisciplinary Health and Development Study. Osteoporos Int. 2002 Dec;13(12):990-5. doi: 10.1007/s001980200137.

    PMID: 12459942BACKGROUND

Related Links

MeSH Terms

Conditions

Fractures, Open

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and Injuries

Study Officials

  • Joseph (Jay) A Janicki, MD, MS

    Ann & Robert H Lurie Children's Hospital of Chicago

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jamie K Burgess, PhD, CCRP

CONTACT

312-227-6531jburgess@luriechildrens.org

Candace C Young, BS

CONTACT

312-227-6427cayoung@luriechildrens.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Assistant Professor of Pediatrics, Northwestern University Feinberg School of Medicine

Study Record Dates

First Submitted

March 25, 2009

First Posted

March 26, 2009

Study Start

March 1, 2010

Primary Completion

January 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

June 29, 2025

Record last verified: 2025-01

Locations

US(1)