NCT03064009

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2017

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2017

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

February 22, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 24, 2017

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 29, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 29, 2018

Completed
Last Updated

May 31, 2018

Status Verified

May 1, 2018

Enrollment Period

1.3 years

First QC Date

February 22, 2017

Last Update Submit

May 29, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Infection

    Infection of the open fracture

    One year after injury

Study Arms (1)

Open Fractures

Patients with Open fractures between the distal radius and the distal tibia

Other: Infection

Interventions

This is an observational trial

Open Fractures

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Open fracture

You may qualify if:

  • Open Fracture treated surgically between distal radius and distal tibia

You may not qualify if:

  • GSW Unable to follow for one year

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Tampa General Hospital

Tampa, Florida, 33606, United States

Location

Harborview Medical Center

Seattle, Washington, 98104, United States

Location

Related Publications (1)

  • Sagi HC, Donohue D, Cooper S, Barei DP, Siebler J, Archdeacon MT, Sciadini M, Romeo M, Bergin PF, Higgins T, Mir H; Center for Bone and Joint Infection. Institutional and Seasonal Variations in the Incidence and Causative Organisms for Posttraumatic Infection following Open Fractures. J Orthop Trauma. 2017 Feb;31(2):78-84. doi: 10.1097/BOT.0000000000000730.

MeSH Terms

Conditions

Infections

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 22, 2017

First Posted

February 24, 2017

Study Start

February 1, 2017

Primary Completion

May 29, 2018

Study Completion

May 29, 2018

Last Updated

May 31, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

Locations