Status:
UNKNOWN
Supracondylar Pinning Antibiotic Stewardship (SPAS) Trial
Lead Sponsor:
Legacy Health System
Conditions:
Supracondylar Humerus Fracture
Infection
Eligibility:
All Genders
Up to 18 years
Phase:
NA
Brief Summary
Prospective, multi-center, randomized controlled trial studying infection rate with or without prophylactic antibiotics at the time of closed reduction and percutaneous pinning of pediatric supracondy...
Detailed Description
The goal of the SPAS trial will be to determine the role of prophylactic antibiotics in closed reduction and percutaneous fixation of pediatric supracondylar humerus fractures. The study will be desig...
Eligibility Criteria
Inclusion
- Closed, isolated extension type supracondylar humerus fracture, Gartland type 2, 3, or 4
Exclusion
- Inability to secure consent
- Open fractures
- Polytrauma
- Pathologic fractures
- Flexion type fracture
- Associated compartment syndrome
- Allergy to cefazolin which precludes its use
- Skeletally mature patients or patients greater than 18 years of age
- Medical comorbidities including immunocompromised state, active infection, and any associated bone, endocrine, or neoplastic conditions contributing to local or generalized abnormal bone mineralization.
- Inability to attain satisfactory reduction and fixation via closed manipulation, resulting in conversion to open reduction
Key Trial Info
Start Date :
January 7 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2023
Estimated Enrollment :
1200 Patients enrolled
Trial Details
Trial ID
NCT04288206
Start Date
January 7 2021
End Date
December 1 2023
Last Update
April 12 2022
Active Locations (1)
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1
Legacy Emanuel Medical Center
Portland, Oregon, United States, 97227