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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
200
2 vials of Vancomycin 1g powder will be applied topically to the open fracture wound site.
University Hospital
San Antonio, Texas, United States
RECRUITINGSan Antonio Military Medical Center
San Antonio, Texas, United States
NOT_YET_RECRUITINGDeep-space infection rate at prophylaxis site
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
Superficial infection rate requiring post-operative medical intervention
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
Unplanned repeat visit rate
The percentage of participants who experience an unscheduled medical encounter related to open fracture-site infection.
Time frame: Within one year of injury date
Readmission rate for open fracture infection
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
Death rate
The rate of death among participants from presumed or documented open fracture site infection, determined by documentation through reliable diagnostic means.
Time frame: Within one year of injury date
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.