Supracondylar Pinning Antibiotic Stewardship (SPAS) Trial

• Status: Recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

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 supracondylar humerus fractures.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Legacy Health System
• Treatments: Anti-Bacterial Agents; Antibiotics, Antitubercular; Cefazolin

Criteria

Inclusion Criteria:

• Closed, isolated extension type supracondylar humerus fracture, Gartland type 2, 3, or 4

Exclusion Criteria:

• 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