Clinical Trial: Preventing Infections in Orthopaedic Patients

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Observational

Official Title: Antibiotic Prophylaxis for Type II and III Open Fractures: a Retrospective Chart Review

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

Detailed Summary:

  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

Sponsor: Olayemi Osiyemi MD

Current Primary Outcome: Rate of fracture site infections [ Time Frame: 30 days ]

number of infections


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Incidence of acute renal injury [ Time Frame: 30 days ]
    number of patients with worsening renal function from baseline
  • type of bacteria infection [ Time Frame: 30 days ]
    name of bacteria infection
  • resistance trend in patients with infections [ Time Frame: 30 days ]
    describe the number of MDRO infections
  • number of secondary infections at site other than fracture sites [ Time Frame: 30 days ]
    describe the number infections at secondary sites


Original Secondary Outcome: Same as current

Information By: Triple O Research Institute PA

Dates:
Date Received: October 14, 2016
Date Started: November 2016
Date Completion: February 2018
Last Updated: October 26, 2016
Last Verified: October 2016