Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2025-12-25 @ 12:39 AM
NCT ID:
NCT03765567
Eligibility Criteria:
Inclusion Criteria:
* Subject or Legal Authorized Representative (LAR) is willing and able to provide written 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 study intervention.
Exclusion Criteria:
* Time from injury \> 24 hours.
* Subjects who have received acute operative care (e.g., washout in the operating room or fixation) of the open fracture at an outside facility.
* Subject or LAR speaks neither English nor Spanish. Note that subjects that are unable to participate in the consent process (e.g. intoxication, poly-trauma, will be 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 will be 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 she states that she is likely to be pregnant, a pregnancy test will be performed; if negative, the subject will be eligible for enrollment.
* Prisoners.
* Participation in other clinical research involving investigational antimicrobial products within 30 days of randomization.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
89 Years
Study:
NCT03765567
Study Brief:
Protocol Section:
NCT03765567