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

  • STATUS
    Recruiting
  • days left to enroll
    44
  • participants needed
    200
  • sponsor
    The University of Texas Health Science Center at San Antonio
Updated on 14 March 2022
injuries
open fracture

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.

Description

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.

Details
Condition Open Fracture
Treatment Vancomycin
Clinical Study IdentifierNCT03765567
SponsorThe University of Texas Health Science Center at San Antonio
Last Modified on14 March 2022

Eligibility

Yes No Not Sure

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
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
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