Preventing Infections in Orthopaedic Patients

October 26, 2016 updated by: Olayemi Osiyemi MD

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

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

Study Overview

Status

Unknown

Conditions

Detailed 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

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Florida
      • West Palm Beach, Florida, United States, 33401
        • Triple O Research Institute PA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who are at least 18 years of age with Type II or III open fractures

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of fracture site infections
Time Frame: 30 days
number of infections
30 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Olayemi Osiyemi MD

Collaborators

Forest Laboratories

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2016

Primary Completion (Anticipated)

October 1, 2017

Study Completion (Anticipated)

February 1, 2018

Study Registration Dates

First Submitted

October 14, 2016

First Submitted That Met QC Criteria

October 26, 2016

First Posted (Estimate)

October 28, 2016

Study Record Updates

Last Update Posted (Estimate)

October 28, 2016

Last Update Submitted That Met QC Criteria

October 26, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TEF-IT-40A

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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