NCT03765567 Placement of Antibiotic Powder in Wounds During the Emergency Room
| NCT ID | NCT03765567 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | The University of Texas Health Science Center at San Antonio |
| Condition | Open Fracture |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2020-10-05 |
| Primary Completion | 2026-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 200 participants in total. It began in 2020-10-05 with a primary completion date of 2026-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 acute emergency department setting.
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.
Contact & Investigator
Robert A De Lorenzo, MD
PRINCIPAL INVESTIGATOR
University of Texas
Frequently Asked Questions
Who can join the NCT03765567 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 89 Years, studying Open Fracture. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03765567 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT03765567 currently recruiting?
Yes, NCT03765567 is actively recruiting participants. Contact the research team at DeLorenzo@uthscsa.edu for enrollment information.
Where is the NCT03765567 trial being conducted?
This trial is being conducted at San Antonio, United States, San Antonio, United States.
Who is sponsoring the NCT03765567 clinical trial?
NCT03765567 is sponsored by The University of Texas Health Science Center at San Antonio. The principal investigator is Robert A De Lorenzo, MD at University of Texas. The trial plans to enroll 200 participants.