Supracondylar Pinning Antibiotic Stewardship (SPAS) Trial

NCT04288206 | Unknown DMC

• 1 other identifier: SPAS Trial
• Study Type: interventional
• Target: 1,200
• Locations: 1 country
• Sites: 1

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.

Conditions

Supracondylar Humerus Fracture; Infection

Keywords

antibiotic stewardship; post operative infection; pediatric; cefazolin

Outcome Measures

Primary Outcomes (2)

• deep post operative infection

  rate of deep post operative infections at the surgical site, requiring treatment including possible hospital admission, intravenous antibiotics, or surgical intervention

  3 months post intervention/surgery

• superficial post operative infection

  rate of superficial post operative infections at the surgical site, requiring treatment limited to oral antibiotics, local wound care, pin removal, or cast change/removal

  3 months post intervention/surgery

Study Arms (2)

Placebo control

PLACEBO COMPARATOR

Patient will receive 'study drug' which is comprised of 300 mL of normal saline without any medication/antibiotic, which will be delivered by intravenous means at the time of surgery.

Drug: normal saline

Cefazolin prophylaxis

ACTIVE COMPARATOR

Patient will receive 'study drug' which is comprised of weight-based dose of cefazolin mixed in 300 mL of normal saline, which will be delivered by intravenous means at the time of surgery.

Drug: Cefazolin

Interventions

Cefazolin DRUG

intravenous cefazolin is being evaluated as a pre-operative prophylactic antibiotic measure with primary outcome being post operative infection rate among participants.

Cefazolin prophylaxis

normal saline DRUG

intravenous normal saline placebo

Placebo control

Eligibility Criteria

• Age: 0 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

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

Sponsors & Collaborators

• Legacy Health System: lead

Study Sites (1)

Legacy Emanuel Medical Center

Portland, Oregon, 97227, United States

RECRUITING

Related Publications (10)

• 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.

  PMID: 25425612 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.

  PMID: 18460689 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.

  PMID: 29398330 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.

  PMID: 22955540 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.

  PMID: 18343301 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.

  PMID: 28467526 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.

  PMID: 30662761 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.

  PMID: 17195791 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.

  PMID: 26558958 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.

  PMID: 20104149 BACKGROUND

MeSH Terms

Conditions

Infections

Interventions

Cefazolin; Saline Solution

Intervention Hierarchy (Ancestors)

Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Bob Umberhandt, MD

  Physician within Legacy Health System

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Justin N Brohard, DO

CONTACT

2177913888; justinbrohard@gmail.com

Bob Umberhandt, MD

CONTACT

5034134488; rumberha@lhs.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 'study drug' will be prepared by a participating pharmacist and labeled with a study identification number. The drug will be otherwise not labeled with regard to the arm of the study. This will be delivered to the operating room and administered to the patient. The patient will be entered into a spreadsheet with the study identification number to be used later to evaluate the data. The enrolling/consenting surgeon, and the patient and consenting family member, will be masked to the arm of the study throughout.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-Investigator

Model Details: 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

Study Record Dates

• First Submitted: February 24, 2020
• First Posted: February 28, 2020
• Study Start: January 7, 2021
• Primary Completion: October 1, 2023
• Study Completion: December 1, 2023
• Last Updated: April 12, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)