About this trial
This is the first prospective controlled study to determine whether the topical application of vancomycin powder reduces infection-related complications when applied to open fracture injuries in the acute emergency department setting.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Vancomycin
Treatment groups
Sponsors and collaborators
The University of Texas Health Science Center at San Antonio
Lead sponsor
United States Army Institute of Surgical Research
Collaborator
San Antonio Military Medical Center
Collaborator