Supracondylar Pinning Antibiotic Stewardship (SPAS) Trial
Status unconfirmed · Not applicable · Has a placebo group
Conditions studied: Supracondylar Humerus Fracture, Infection
In brief
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 supracondylar humerus fractures.
Key facts
- Study ID
- NCT04288206
- Run by
- Legacy Health System
- People needed
- 1200
- Starts
- 2021-01-07
- Expected to finish
- 2023-12-01
- Last updated by the study team
- 2022-04-12
Who can join
Age: any, up to 18. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Closed, isolated extension type supracondylar humerus fracture, Gartland type 2, 3, or 4
You may not qualify if…
- 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
Where it is running
- Legacy Emanuel Medical Center — Portland, Oregon, United States (enrolling)
Full record on ClinicalTrials.gov
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