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Supracondylar Humerus FractureSPASNCT04288206

Supracondylar Pinning Antibiotic Stewardship (SPAS) Trial

A study testing Cefazolin and normal saline in people with Supracondylar Humerus Fracture and Infection, run by Legacy Health System at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 0 to 18 yearsHealthy volunteers can take part
Conditions the study is for
Supracondylar Humerus Fracture, Infection
What is being tested?
Cefazolin and normal saline
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,200 participants
Where
1 siteUnited States
Study dates
7 Jan 2021to Dec 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 0 to 18 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

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

Who cannot join

  • Inability to secure consent
  • Open fractures
  • Polytrauma
  • Pathologic fractures
  • Flexion type fracture
  • Associated compartment syndrome
Show all 10Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Justin N Brohard, DO contact

2177913888

justinbrohard@gmail.com

Bob Umberhandt, MD contact

5034134488

rumberha@lhs.org

United States1 site, 1 recruiting

  • Legacy Emanuel Medical Center

    Portland, Oregon, 97227

    Bette Manulik, bmanulik@lhs.org

    Recruiting

Other trials in United States

About this study

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.

Read the 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.

Being tested
Cefazolin, normal saline
Keywords
antibiotic stewardship, post operative infection, pediatric, cefazolin
Medical subject headings
Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CefazolinDrug

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

  • normal salineDrug

    intravenous normal saline placebo

Study groups in NCT04288206
Study groupRoleWhat they receive
Placebo controlPlacebo comparatorPatient 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.
Receives: Drug: normal saline
Cefazolin prophylaxisActive comparatorPatient 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.
Receives: Drug: Cefazolin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 3 months post intervention/surgery

  2. 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

    Measured: 3 months post intervention/surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Feb 2020
  2. Study start7 Jan 2021
  3. Primary completionOct 2023 (estimated)
  4. Study completionDec 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
1,200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04288206
Sponsor's protocol ID
SPAS Trial
Acronym
SPAS
Status last verified
Apr 2022
First submitted
24 Feb 2020
Last updated
12 Apr 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: All data will be de-identified prior to sharing amongst participating researchers. Each participating site will maintain a spreadsheet of participants with their study identification numbers. This information will be de-identified prior to sharing with the PI and safety monitor at LHS. This will occur at a midterm assessment for safety, as well as at the completion of data collection when it is time to process and analyze the data.

Publications

  • 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.

    PubMed 25425612

  • Prokuski L. Prophylactic antibiotics in orthopaedic surgery. J Am Acad Orthop Surg. 2008 May;16(5):283-93. doi: 10.5435/00124635-200805000-00007.

    PubMed 18460689

  • 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.

    PubMed 29398330

  • 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.

    PubMed 22955540

  • 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.

    PubMed 18343301

  • 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.

    PubMed 28467526

  • 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.

    PubMed 30662761

  • 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.

    PubMed 17195791

  • 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.

    PubMed 26558958

  • 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.

    PubMed 20104149

Questions about this trial

What is this clinical trial studying?

A study testing Cefazolin and normal saline in people with Supracondylar Humerus Fracture and Infection, run by Legacy Health System at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 12 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Justin N Brohard, DO (2177913888, justinbrohard@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

deep post operative infection (time frame: 3 months post intervention/surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04288206, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2022.

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