Status:
RECRUITING
Placement of Antibiotic Powder in Wounds During the Emergency Room
Lead Sponsor:
The University of Texas Health Science Center at San Antonio
Collaborating Sponsors:
United States Army Institute of Surgical Research
San Antonio Military Medical Center
Conditions:
Open Fracture
Eligibility:
All Genders
18-89 years
Phase:
PHASE4
Brief Summary
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 a...
Detailed Description
Open fracture injuries are highly susceptible to infection and infection-related complications. The current routine treatment for these injuries includes the use of systemic IV antibiotics. However, o...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 5 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2027
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT03765567
Start Date
October 5 2020
End Date
July 1 2027
Last Update
August 1 2025
Active Locations (2)
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1
University Hospital
San Antonio, Texas, United States, 78229
2
San Antonio Military Medical Center
San Antonio, Texas, United States, 78234