Assessment of Severe Extremity Wound Bioburden at the Time of Definitive Wound Closure or Coverage (NCT01496014) | Clinical Trial Compass
CompletedNot Applicable
Assessment of Severe Extremity Wound Bioburden at the Time of Definitive Wound Closure or Coverage
United States646 participantsStarted 2011-09
Plain-language 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 populations.
Who can participate
Age range18 Years – 64 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. Patient speaks neither English nor Spanish
✕. Patient is a prisoner
✕. Patient has been diagnosed with a severe psychiatric condition