drugset / Trial / NCT04288206
Supracondylar Pinning Antibiotic Stewardship (SPAS) Trial
RandomizedParallel-groupTriple-blindTreatment
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.
Timeline
- Start
- 2021-01-07
- Primary completion
- 2023-10
- Completion
- 2023-12
Publications
- Background Campbell KA, Stein S, Looze C, Bosco JA. Antibiotic stewardship in orthopaedic surgery: principles and practice. J Am Acad Orthop Surg. 2014 Dec;22(12):772-81. doi: 10.5435/JAAOS-22-12-772.
- Background Prokuski L. Prophylactic antibiotics in orthopaedic surgery. J Am Acad Orthop Surg. 2008 May;16(5):283-93. doi: 10.5435/00124635-200805000-00007.
- Background Johnson SP, Zhong L, Chung KC, Waljee JF. Perioperative Antibiotics for Clean Hand Surgery: A National Study. J Hand Surg Am. 2018 May;43(5):407-416.e1. doi: 10.1016/j.jhsa.2017.11.018. Epub 2018 Feb 3.
- Background Formaini N, Jacob P, Willis L, Kean JR. Evaluating the use of preoperative antibiotics in pediatric orthopaedic surgery. J Pediatr Orthop. 2012 Oct-Nov;32(7):737-40. doi: 10.1097/BPO.0b013e318269543b.
- Background Rizvi M, Bille B, Holtom P, Schnall SB. The role of prophylactic antibiotics in elective hand surgery. J Hand Surg Am. 2008 Mar;33(3):413-20. doi: 10.1016/j.jhsa.2007.12.017.
- Background Berrios-Torres SI, Umscheid CA, Bratzler DW, Leas B, Stone EC, Kelz RR, Reinke CE, Morgan S, Solomkin JS, Mazuski JE, Dellinger EP, Itani KMF, Berbari EF, Segreti J, Parvizi J, Blanchard J, Allen G, Kluytmans JAJW, Donlan R, Schecter WP; Healthcare Infection Control Practices Advisory Committee. Centers for Disease Control and Prevention Guideline for the Prevention of Surgical Site Infection, 2017. JAMA Surg. 2017 Aug 1;152(8):784-791. doi: 10.1001/jamasurg.2017.0904.
- Background Vaquero-Picado A, Gonzalez-Moran G, Moraleda L. Management of supracondylar fractures of the humerus in children. EFORT Open Rev. 2018 Oct 1;3(10):526-540. doi: 10.1302/2058-5241.3.170049. eCollection 2018 Oct.
- Background Iobst CA, Spurdle C, King WF, Lopez M. Percutaneous pinning of pediatric supracondylar humerus fractures with the semisterile technique: the Miami experience. J Pediatr Orthop. 2007 Jan-Feb;27(1):17-22. doi: 10.1097/bpo.0b013e31802b68dc.
- Background Schroeder NO, Seeley MA, Hariharan A, Farley FA, Caird MS, Li Y. Utility of Postoperative Antibiotics After Percutaneous Pinning of Pediatric Supracondylar Humerus Fractures. J Pediatr Orthop. 2017 Sep;37(6):363-367. doi: 10.1097/BPO.0000000000000685.
- Background Bashyal RK, Chu JY, Schoenecker PL, Dobbs MB, Luhmann SJ, Gordon JE. Complications after pinning of supracondylar distal humerus fractures. J Pediatr Orthop. 2009 Oct-Nov;29(7):704-8. doi: 10.1097/BPO.0b013e3181b768ac.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Cefazolin | Small molecule | — | Intravenous |