Recruiting

Antibiotic Stewardship

Sponsor:

Legacy Health System

Code:

NCT04288206

Conditions

Supracondylar Humerus Fracture

Infection

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Accepted

Interventions

Cefazolin

normal saline

Study Details

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

Study ID

NCT04288206

Start date

Jan 7, 2021

Status verified date

Apr, 2022

Completion date

Dec, 2023

Anticipated

Primary completion date

Oct, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Accepted

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

Study Design

Enrollment

1200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

placebo comparator: Placebo control

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.

active comparator: Cefazolin prophylaxis

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.

Interventions

Cefazolin

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

normal saline

intravenous normal saline placebo

Primary outcome measure

  • deep post operative infection [ Time Frame: 3 months post intervention/surgery ]
  • superficial post operative infection [ Time Frame: 3 months post intervention/surgery ]

Central Contacts and Locations

Central contacts

Justin N Brohard, DO

2177913888justinbrohard@gmail.com

Bob Umberhandt, MD

5034134488rumberha@lhs.org

Locations

Legacy Emanuel Medical Center

Recruiting

Portland, Oregon, United States, 97227

Contacts

Bette Manulik

bmanulik@lhs.org

More Information

Sponsor

Legacy Health System

Last update posted

Apr 12, 2022

Last verified

Apr, 2022

Keywords

  • antibiotic stewardship
  • post operative infection
  • pediatric
  • cefazolin

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Legacy Health System on 2022-04-12.