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

• Sponsor: University of Washington (Other)
• Overall Status: Terminated
• CT.gov ID: NCT03064009
• Collaborator: (none)
• Enrollment: 300
• Locations: 2
• Actual Duration (Months): 15.8
• Patients Per Site: 150
• Patients Per Site Per Month: 9.5

Study Details

Study Description

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	Phase
Infection	Other: Infection

Study Design

• 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: Feb 1, 2017
• Actual Primary Completion Date: May 29, 2018
• Actual Study Completion Date: May 29, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Infection [One year after injury]

   Infection of the open fracture

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

Open Fracture treated surgically between distal radius and distal tibia

-

Exclusion Criteria:

• GSW Unable to follow for one year

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tampa General Hospital	Tampa	Florida	United States	33606
2	Harborview Medical Center	Seattle	Washington	United States	98104

Sponsors and Collaborators

• University of Washington

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Claude Sagi, Professor, University of Washington
• ClinicalTrials.gov Identifier: NCT03064009
• Other Study ID Numbers: 51835-ED
• First Posted: Feb 24, 2017
• Last Update Posted: May 31, 2018
• Last Verified: May 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Infections; Communicable Diseases; Wound Infection; Osteomyelitis; Fractures, Open

Study Results

No Results Posted as of May 31, 2018