RECRUITING

Placement of Antibiotic Powder in Wounds During the Emergency Room

Conditions

Open Fracture infection vancomycin topical antibiotic antibiotic prophylaxis

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Placement of Antibiotic Powder in Wounds During the Emergency Room (POWDER) Study

Quick Facts

Study Start:2020-10-05

Study Completion:2025-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT03765567

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 89 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Study Contact

Robert A De Lorenzo, MD

CONTACT

210-567-0056

DeLorenzo@uthscsa.edu

Principal Investigator

Robert A De Lorenzo, MD

PRINCIPAL_INVESTIGATOR

University of Texas

Study Locations (Sites)

University Hospital

San Antonio, Texas, 78229

United States

San Antonio Military Medical Center

San Antonio, Texas, 78234

United States

Collaborators and Investigators

Sponsor: The University of Texas Health Science Center at San Antonio

Robert A De Lorenzo, MD, PRINCIPAL_INVESTIGATOR, University of Texas

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-10-05

Study Completion Date2025-06

Study Record Updates

Study Start Date2020-10-05

Study Completion Date2025-06

Terms related to this study

Keywords Provided by Researchers

infection
vancomycin
topical antibiotic
antibiotic prophylaxis

Additional Relevant MeSH Terms

Open Fracture