Clinical trial NCT04288206: Supracondylar Pinning Antibiotic Stewardship (SPAS) Trial
Official title: Supracondylar Pinning Antibiotic Stewardship (SPAS) Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Supracondylar Humerus Fracture
Infection
Keywords: antibiotic stewardship
post operative infection
pediatric
cefazolin
Lead sponsor: Legacy Health System
Sponsor class: OTHER
First posted: 2020-02-28
Enrollment: 1200
Sex: ALL
Minimum age (years): 0
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: intervention arm of intravenous cefazolin at the time of surgery (standard of care) vs placebo arm of intravenous normal saline at the time of surgery
Primary purpose: TREATMENT

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 supracondylar humerus fractures.

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 designed as a prospective, double-blinded, two-arm, non-inferiority trial. The control arm will receive standard of care preoperative prophylactic antibiotics. The intervention group will receive a preoperative saline placebo. The primary outcome of the study will be the development of a surgical site infection, including all infections both superficial and deep. Secondary outcomes will include rate and type of post-operative complications in either group, to account for any drug-related adverse outcomes. The hypothesis is that this surgery is safe to perform without prophylactic antibiotics, and the investigators anticipate finding no difference in infection rates between the two groups. Inclusion criteria will consist of an isolated, closed, displaced supracondylar humerus fracture treated with closed reduction and temporary percutaneous pinning. Immunocompromised patients, pathological fractures, open fractures, polytrauma, skeletally mature patients, and those treated primarily with open reduction or those converted to open reduction will be excluded. Because of the low infection rate observed in this type of surgery, the sample size for the study is estimated at 600 patients per arm for adequate power. With a multicenter design, the expectation will be enrollment over the course of 1-2 years with a follow up of approximately 3 months post-surgical intervention per participant.

Eligibility 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

Primary outcomes:
measure: deep post operative infection
timeFrame: 3 months post intervention/surgery
measure: superficial post operative infection
timeFrame: 3 months post intervention/surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Portland
country: United States
facility: Legacy Emanuel Medical Center
state: Oregon
Study officials:
affiliation: Physician within Legacy Health System
name: Bob Umberhandt, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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citation: 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.
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citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.