Placement of Antibiotic Powder in Wounds During the Emergency Room (POWDER)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03765567|
Recruitment Status : Recruiting
First Posted : December 5, 2018
Last Update Posted : March 2, 2022
|Condition or disease||Intervention/treatment||Phase|
|Open Fracture||Drug: Vancomycin||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Placement of Antibiotic Powder in Wounds During the Emergency Room (POWDER) Study|
|Actual Study Start Date :||October 5, 2020|
|Estimated Primary Completion Date :||January 2023|
|Estimated Study Completion Date :||January 2023|
Experimental: Intervention Arm
Subjects randomized to the Intervention Arm will receive usual care plus two (2) grams of Vancomycin powder administered topically. In the emergency room prior to surgical intervention, a qualified member of the study team or clinical team member will apply 2 grams of vancomycin powder directly to the open fracture site such that all visible surfaces of the wound are completely and uniformly covered, including bone edges.
2 vials of Vancomycin 1g powder will be applied topically to the open fracture wound site.
No Intervention: Control Arm
Subjects randomized to the Control Arm will receive usual care for open long bone fracture as determined by the treating physician.
No Intervention: Observational Arm
Subjects who otherwise meet the criteria to be included in the study but are not able to provide consent, either themselves or through a Legally Authorized Representative, will be placed in the Observational Arm and receive usual care with no experimental intervention.
- Deep-space infection rate at prophylaxis site [ 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.
- Superficial infection rate requiring post-operative medical intervention [ 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.
- Unplanned repeat visit rate [ Time Frame: Within one year of injury date ]The percentage of participants who experience an unscheduled medical encounter related to open fracture-site infection.
- Readmission rate for open fracture 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.
- Death rate [ 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03765567
|Contact: Robert A De Lorenzo, MD||210-567-0056||DeLorenzo@uthscsa.edu|
|United States, Texas|
|San Antonio, Texas, United States, 78229|
|Contact: Robert DeLorenzo, MD 210-567-4292 email@example.com|
|Contact: Stephanie Martinez 210 450-8566 firstname.lastname@example.org|
|Principal Investigator: Robert A De Lorenzo, MD|
|San Antonio Military Medical Center||Not yet recruiting|
|San Antonio, Texas, United States, 78234|
|Contact: Steven G Schauer, DO email@example.com|
|Principal Investigator: Steven G Schauer, DO|
|Principal Investigator:||Robert A De Lorenzo, MD||University of Texas|