Status:
COMPLETED
Assessment of Severe Extremity Wound Bioburden at the Time of Definitive Wound Closure or Coverage
Lead Sponsor:
Major Extremity Trauma Research Consortium
Collaborating Sponsors:
United States Department of Defense
Conditions:
Open Fracture
Eligibility:
All Genders
18-64 years
Brief Summary
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 populati...
Detailed Description
Infection remains the most common and significant complication following high energy fractures. The strategies used in the prevention of deep infection following severe open fracture wounds have remai...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 30 2022
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT01496014
Start Date
September 1 2011
End Date
June 30 2022
Last Update
July 29 2022
Active Locations (40)
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1
Naval Medical Center San Diego
San Diego, California, United States, 92134
2
UCSF Medical Center
San Francisco, California, United States, 94115
3
Denver Health and Hospital Authority
Denver, Colorado, United States, 80204
4
University of Miami Ryder Trauma Center
Miami, Florida, United States, 33101