Phase
Condition
Bone Fractures
Treatment
Vancomycin
Clinical Study ID
Ages 18-89 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Subject or Legal Authorized Representative (LAR) is willing and able to providewritten informed consent.
Adult 18 years of age or older.
Open fracture of the humerus, radius, ulna, femur, tibia, and/or fibula.
24 hours or less has elapsed from the estimated time of injury to studyintervention.
Exclusion
Exclusion Criteria:
Time from injury > 24 hours.
Subjects who have received acute operative care (e.g., washout in the operating roomor fixation) of the open fracture at an outside facility.
Subject or LAR speaks neither English nor Spanish. Note that subjects that areunable to participate in the consent process (e.g. intoxication, poly-trauma, willbe enrolled into the observational arm where passive data collection will occur).
High-potency antibiotic powder or solution applied to the wound prior to enrollment.Simple ointment (i.e., bacitracin ointment) or antibiotic-impregnated dressings willbe permitted.
Documented allergies or serious reactions to vancomycin. History of uncomplicated "red man syndrome" will not be considered a reason for exclusion.
Pregnant subjects. If the subject is a female of childbearing potential, and shestates that she is likely to be pregnant, a pregnancy test will be performed; ifnegative, the subject will be eligible for enrollment.
Prisoners.
Participation in other clinical research involving investigational antimicrobialproducts within 30 days of randomization.
Study Design
Study Description
Connect with a study center
San Antonio Military Medical Center
San Antonio, Texas 78234
United StatesSite Not Available
University Hospital
San Antonio, Texas 78229
United StatesActive - Recruiting
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