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Preventing Infections in Orthopaedic Patients

O

Olayemi Osiyemi MD

Status

Unknown

Conditions

Open Fracture

Study type

Observational

Funder types

Other
Industry

Identifiers

NCT02948387
TEF-IT-40A

Details and patient eligibility

About

Determine if antibiotic prophylaxis with intravenous cephalosporin and aminoglycoside in patients with Type II and II open fractures is safe and effective.

Full description

  1. Determine the safety and efficacy of antibiotic prophylaxis in type II and II open fractures when using IV Cephalosporin and aminoglycoside.
  2. Identify the incidence of acute kidney injury.
  3. Identify the type and number of associated infections
  4. Identify the antibiotic resistance profile noted
  5. Identify any secondary infections at sites other than the fracture site

Enrollment

50 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Male or Female >= 18 years old
  • Patients are diagnosed with a Type II or III open fracture

Exclusion criteria

  • Prior to treatment, report of an allergy to beta-lactam or aminoglycoside antibiotics
  • pregnancy
  • did not receive 72 hours of IV antibiotic prophylaxis with 1st or 2nd generation cephalosporin and either gentamicin or tobramycin
  • receiving ongoing inpatient care

Trial contacts and locations

1

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Central trial contact

Olayemi Osiyemi, MD; Paul Glickman

Data sourced from clinicaltrials.gov

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