The Treatment of Type I Open Fractures in Pediatrics

Conditions

• Fractures, Open

Eligibility Criteria

Sex

ALL

Age

3 Years - 14 Years

Healthy Volunteers

Not accepted

Interventions

• Formal Operative Treatment — PROCEDURE
  Children randomized to the OR arm will be taken to the OR within 24 hours for irrigation and debridement and appropriate bone management.
• Emergency Department Treatment — PROCEDURE
  Children in the ED arm will have a washout in the emergency room under conscious sedation, a closed reduction and home antibiotics.

Study Details

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.

Key Dates

Start date

Mar 31, 2010

Status verified

Jan 2025

Primary completion

Jan 31, 2026

Completion

Jun 30, 2026

Study Design

Enrollment

300 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

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

Primary Outcome Measure

Rate of infection [ Time Frame: 2 weeks ]

Central Contacts

• Jamie K Burgess, PhD, CCRP
  312-227-6531
  [email protected]
• Candace C Young, BS
  312-227-6427
  [email protected]

Locations (1)

Find similar trials in Chicago, IL

Related Studies

• Safety, Efficacy, & Use of ViviGen Cellular Bone Matrix Allograft in Orthopaedic Fracture Care
  Recruiting · LifeNet Health · Orlando, Florida
• Antibiotic Prophylaxis in Pediatric Open Fractures
  PHASE4 · Enrolling By Invitation · St. Louis University · St Louis, Missouri