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

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ClinicalTrials.gov Identifier: NCT03064009
Recruitment Status : Terminated (Study halted prematurely and will not resume; participants are no longer being examined or receiving intervention. Low enrollment and PI leaving institution)
First Posted : February 24, 2017
Last Update Posted : May 31, 2018
Sponsor:
Information provided by (Responsible Party):
Claude Sagi, University of Washington

Brief Summary:
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

Condition or disease Intervention/treatment
Infection Other: Infection

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Study Type : Observational
Actual Enrollment : 300 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Regional and Seasonal Variations in the Incidence and Causative Organisms for Post-traumatic Wound Infections and Osteomyelitis After Open Fractures
Actual Study Start Date : February 1, 2017
Actual Primary Completion Date : May 29, 2018
Actual Study Completion Date : May 29, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures

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




Primary Outcome Measures :
  1. Infection [ Time Frame: One year after injury ]
    Infection of the open fracture



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Open fracture
Criteria

Inclusion Criteria:

Open Fracture treated surgically between distal radius and distal tibia

-

Exclusion Criteria:

  • GSW Unable to follow for one year

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03064009


Locations
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United States, Florida
Tampa General Hospital
Tampa, Florida, United States, 33606
United States, Washington
Harborview Medical Center
Seattle, Washington, United States, 98104
Sponsors and Collaborators
University of Washington

Publications of Results:
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Responsible Party: Claude Sagi, Professor, University of Washington
ClinicalTrials.gov Identifier: NCT03064009     History of Changes
Other Study ID Numbers: 51835-ED
First Posted: February 24, 2017    Key Record Dates
Last Update Posted: May 31, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Infection
Communicable Diseases
Wound Infection
Osteomyelitis
Fractures, Open
Bone Diseases, Infectious
Bone Diseases
Musculoskeletal Diseases
Fractures, Bone
Wounds and Injuries