Assessment of Severe Extremity Wound Bioburden at the Time of Definitive Wound Closure or Coverage

Completed

Conditions studied: Open Fracture

In brief

The purpose of this study is to characterize the bacteria in the wound "bioburden" at the time of definitive wound coverage/closure of severe tibia fractures in both the military and civilian populations.

Key facts

Study ID

NCT01496014

Run by

Major Extremity Trauma Research Consortium

People needed

646

Starts

2011-09-01

Expected to finish

2022-06-30

Last updated by the study team

2026-05-05

Who can join

Age: 18 and older, up to 64. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• All open Grade III tibia fractures (plateau, shaft, pilon) requiring a second procedure following fixation, or traumatic transtibial amputations requiring delayed primary closure, skin grafting and/ or flap coverage.
• Ages 18 - 64 years inclusive
• Patients may have risk factors for infection including diabetes, immunosuppression from steroids or other medications, HIV, or other infections.
• Patients may have a traumatic brain injury.
• Patients may have other fractures including spine, upper extremity fractures, contralateral lower extremity injuries, ipsilateral pelvis, hip, femur or foot injuries.
• Patients may be treated initially at an outside institution prior to transfer to the study institution, as long as the definitive fixation was not performed prior to entrance into the study.
• Patients with bilateral injuries that meet inclusion criteria may be included, but only the limb rated as "more severe" by the treating surgeon will be enrolled in the study.
• Patients may have co-existing non-tibial infection, with or without antibiotic treatment.
• Patients may have an existing infection of the surgical wound under treatment at the time of wound closure.
• Patients may be definitively fixed using any method (nail, plate, ex fix)
• Patients may have a fasciotomy

You may not qualify if…

• Patient speaks neither English nor Spanish
• Patient is a prisoner
• Patient has been diagnosed with a severe psychiatric condition
• Patient is intellectually challenged without adequate family support
• Patient lives outside the hospital's catchment area
• Patients with planned follow-up at another medical center

Where it is running

• Naval Medical Center San Diego — San Diego, California, United States
• UCSF Medical Center — San Francisco, California, United States
• Denver Health and Hospital Authority — Denver, Colorado, United States
• University of Miami Ryder Trauma Center — Miami, Florida, United States
• Florida Orthopaedic Institute — Tampa, Florida, United States
• Emory University Dept of Orthopaedics — Atlanta, Georgia, United States
• OrthoIndy at St Vincent — Indianapolis, Indiana, United States
• University of Iowa Hospitals & Clinics — Iowa City, Iowa, United States
• University of Kansas Medical Center — Kansas City, Kansas, United States
• Louisiana State University — New Orleans, Louisiana, United States
• University of Maryland, R Adams Cowley Shock Trauma Center — Baltimore, Maryland, United States
• Walter Reed Military Medical Center — Bethesda, Maryland, United States
• Walter Reed National Military Medical Center — Bethesda, Maryland, United States
• Boston Medical Center — Boston, Massachusetts, United States
• Orthopaedic Associates of Michigan, Spectrum Health — Grand Rapids, Michigan, United States
• Hennepin County Medical Center / Minneapolis — Minneapolis, Minnesota, United States
• Regions Hospital — Saint Paul, Minnesota, United States
• University of Mississippi Medical Center — Jackson, Mississippi, United States
• Barnes Jewish Hospital — St Louis, Missouri, United States
• St. Louis Medical Center — St Louis, Missouri, United States
• University of Rochester — Rochester, New York, United States
• Carolinas Medical Center — Charlotte, North Carolina, United States
• Duke University Hospital — Durham, North Carolina, United States
• Wake Forest University Baptist Medical Center — Winston-Salem, North Carolina, United States
• MetroHealth Medical Center — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.