Regional and Seasonal Variations in the Incidence and Causative Organisms for Post-traumatic Wound Infections and Osteomyelitis After Open Fractures

May 29, 2018 updated by: Claude Sagi, University of Washington
To determine if there is a relationship between people with open fractures and the season and location of where the injury occurred and the infections they develop

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

300

Contacts and Locations

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

Study Locations

  • United States
    • Florida
      • Tampa, Florida, United States, 33606
        • Tampa General Hospital
    • Washington
      • Seattle, Washington, United States, 98104
        • Harborview Medical Center

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

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Open fracture

Description

Inclusion Criteria:

Open Fracture treated surgically between distal radius and distal tibia

-

Exclusion Criteria:

  • GSW Unable to follow for one year

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

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Open Fractures
Patients with Open fractures between the distal radius and the distal tibia
Other: Infection
This is an observational trial

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Infection
Time Frame: One year after injury
Infection of the open fracture
One year after injury

Collaborators and Investigators

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

Sponsor

University of Washington

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

February 1, 2017

Primary Completion (Actual)

May 29, 2018

Study Completion (Actual)

May 29, 2018

Study Registration Dates

First Submitted

February 22, 2017

First Submitted That Met QC Criteria

February 22, 2017

First Posted (Actual)

February 24, 2017

Study Record Updates

Last Update Posted (Actual)

May 31, 2018

Last Update Submitted That Met QC Criteria

May 29, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 51835-ED

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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