Study Summary
This trial is testing whether giving antibiotics to kids with a broken arm prevents infection.
- Supracondylar Humerus Fractures
- Infection
Treatment Effectiveness
Effectiveness Progress
Study Objectives
2 Primary · 0 Secondary · Reporting Duration: 3 months post intervention/surgery
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
Cefazolin prophylaxis
1 of 2
Placebo control
1 of 2
Active Control
Non-Treatment Group
1200 Total Participants · 2 Treatment Groups
Primary Treatment: Cefazolin prophylaxis · Has Placebo Group · N/A
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age No minimum age - 18 · All Participants · 1 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:- Schroeder, Nicholas O., Mark A. Seeley, Arun Hariharan, Frances A. Farley, Michelle S. Caird, and Ying Li. 2017. “Utility of Postoperative Antibiotics After Percutaneous Pinning of Pediatric Supracondylar Humerus Fractures”. Journal of Pediatric Orthopaedics. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/bpo.0000000000000685.
- Johnson, Shepard P., Lin Zhong, Kevin C. Chung, and Jennifer F. Waljee. 2018. “Perioperative Antibiotics for Clean Hand Surgery: A National Study”. The Journal of Hand Surgery. Elsevier BV. doi:10.1016/j.jhsa.2017.11.018.
- Formaini, Nathan, Paul Jacob, Leisel Willis, and John R. Kean. 2012. “Evaluating the Use of Preoperative Antibiotics in Pediatric Orthopaedic Surgery”. Journal of Pediatric Orthopaedics. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/bpo.0b013e318269543b.
- Vaquero-Picado, Alfonso, Gaspar González-Morán, and Luis Moraleda. 2018. “Management of Supracondylar Fractures of the Humerus in Children”. EFORT Open Reviews. Bioscientifica. doi:10.1302/2058-5241.3.170049.
- Iobst, Christopher A., Craig Spurdle, Wesley F. King, and Miguel Lopez. 2007. “Percutaneous Pinning of Pediatric Supracondylar Humerus Fractures with the Semisterile Technique”. Journal of Pediatric Orthopaedics. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/bpo.0b013e31802b68dc.
- Rizvi, Murtaza, Brian Bille, Paul Holtom, and Stephen B. Schnall. 2008. “The Role of Prophylactic Antibiotics in Elective Hand Surgery”. The Journal of Hand Surgery. Elsevier BV. doi:10.1016/j.jhsa.2007.12.017.
- Berríos-Torres, Sandra I., Craig A. Umscheid, Dale W. Bratzler, Brian Leas, Erin C. Stone, Rachel R. Kelz, Caroline E. Reinke, et al.. 2017. “Centers for Disease Control and Prevention Guideline for the Prevention of Surgical Site Infection, 2017”. JAMA Surgery. American Medical Association (AMA). doi:10.1001/jamasurg.2017.0904.
- Campbell, Kirk A., Spencer Stein, Christopher Looze, and Joseph A. Bosco. 2014. “Antibiotic Stewardship in Orthopaedic Surgery”. Journal of the American Academy of Orthopaedic Surgeons. Ovid Technologies (Wolters Kluwer Health). doi:10.5435/jaaos-22-12-772.
- Prokuski, Laura. 2008. “Prophylactic Antibiotics in Orthopaedic Surgery”. Journal of the American Academy of Orthopaedic Surgeons. Ovid Technologies (Wolters Kluwer Health). doi:10.5435/00124635-200805000-00007.
- Bashyal, Ravi K., Jennifer Y. Chu, Perry L. Schoenecker, Matthew B. Dobbs, Scott J. Luhmann, and J. Eric Gordon. 2009. “Complications After Pinning of Supracondylar Distal Humerus Fractures”. Journal of Pediatric Orthopaedics. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/bpo.0b013e3181b768ac.
- 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.
- Prokuski L. Prophylactic antibiotics in orthopaedic surgery. J Am Acad Orthop Surg. 2008 May;16(5):283-93. doi: 10.5435/00124635-200805000-00007.
- 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.
- 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. Erratum In: JAMA Surg. 2017 Aug 1;152(8):803.
- 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.
- 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.
- Justin Brohard 2021. "Supracondylar Pinning Antibiotic Stewardship (SPAS) Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04288206.
Frequently Asked Questions
Is this experiment enrolling the elderly population?
"According to the study's guidelines, minors ranging from newborns to 18 years of age are eligible for enrollment." - Anonymous Online Contributor
For what health issues is Cefazolin prophylaxis typically prescribed?
"Cefazolin prophylaxis is traditionally employed as a preventive measure for surgery. Yet, this therapeutic intervention can also combat skin and subcutaneous tissue bacterial infections, prophylactic measures against post-operative infection, and other related maladies." - Anonymous Online Contributor
Is this trial recruiting participants presently?
"The clinicaltrials.gov registry reveals that this medical trial is still recruiting patients and was first posted on the 7th of January 2021 with its most recent update made on 8th April 2022." - Anonymous Online Contributor
Who is eligible to join this experimental research?
"Eligibility for this medical trial necessitates that applicants are under 18 years of age and have an infection. 1200 people will ultimately be recruited into the experiment." - Anonymous Online Contributor
To what extent is this experiment involving participants?
"Affirmative. As evidenced on clinicaltrials.gov, this research project is currently recruiting participants and was initially publicized on July 1st 2021. The team hopes to enrol 1200 patients from a single trial site by April 8th 2022." - Anonymous Online Contributor
Has Cefazolin been tested as a form of preventive medicine in prior studies?
"At present, 17 clinical trials currently explore the use of Cefazolin prophylaxis. Of these studies, 2 are in phase 3 and they span 151 medical centres across Singapore and New South Wales." - Anonymous Online Contributor