Vancomycin
Drug2 vials of Vancomycin 1g powder will be applied topically to the open fracture wound site.
Other names: NDC (National Drug Code) 67457-340-01, Topical vancomycin, Vancomycin powder
NCT Number: NCT03765567
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.
Interested in participating?
Request Info18 year–89 year
All sexes
Interventional
Phase 4
San Antonio Military Medical Center, San Antonio, Texas, United States
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, open fracture injuries often have compromised blood supply, reducing the amount of antibiotic that reaches the target tissue while increasing risk of injury to non-target organs. This trial aims to evaluate the effectiveness of early application of a topical vancomycin antibiotic powder on open fracture wounds, in combination with the usual treatment, in reducing the risk of infection seen in these injuries.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
2 vials of Vancomycin 1g powder will be applied topically to the open fracture wound site.
Other names: NDC (National Drug Code) 67457-340-01, Topical vancomycin, Vancomycin powder
Time frame: Within one year of injury date
The percentage of participants who develop an infection of the study open fracture requiring post-operative surgical intervention within one year of injury.
Time frame: Within one year of injury date
The percentage of participants who develop an infection of the study open fracture that requires post-operative medical intervention, including addition or change of antibiotic, bedside application of incision & drainage, needle aspiration, and bedside application of a drain.
Time frame: Within one year of injury date
The percentage of participants who experience an unscheduled medical encounter related to open fracture-site infection.
Time frame: Within one year of injury date
The percentage of participants who are readmitted to the hospital due to infection or complication of the study open fracture. Included in this assessment is sepsis and sepsis-related conditions arising from an open fracture infection.
Time frame: Within one year of injury date
The rate of death among participants from presumed or documented open fracture site infection, determined by documentation through reliable diagnostic means.
Contact information is provided by the study sponsor or research team.
The University of Texas Health Science Center at San Antonio
Other
Placement of Antibiotic Powder in Wounds During the Emergency Room (POWDER) Study
Acronym: POWDER
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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