Placement of Antibiotic Powder in Wounds During the Emergency Room

Last updated: July 25, 2024
Sponsor: The University of Texas Health Science Center at San Antonio
Overall Status: Active - Recruiting

Phase

4

Condition

Bone Fractures

Treatment

Vancomycin

Clinical Study ID

NCT03765567
HSC20180520H
W81XWH-18-2-0074
  • Ages 18-89
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Subject or Legal Authorized Representative (LAR) is willing and able to providewritten 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 studyintervention.

Exclusion

Exclusion Criteria:

  • Time from injury > 24 hours.

  • Subjects who have received acute operative care (e.g., washout in the operating roomor fixation) of the open fracture at an outside facility.

  • Subject or LAR speaks neither English nor Spanish. Note that subjects that areunable to participate in the consent process (e.g. intoxication, poly-trauma, willbe 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 willbe 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 shestates that she is likely to be pregnant, a pregnancy test will be performed; ifnegative, the subject will be eligible for enrollment.

  • Prisoners.

  • Participation in other clinical research involving investigational antimicrobialproducts within 30 days of randomization.

Study Design

Total Participants: 200
Treatment Group(s): 1
Primary Treatment: Vancomycin
Phase: 4
Study Start date:
October 05, 2020
Estimated Completion Date:
June 30, 2025

Study 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.

Connect with a study center

  • San Antonio Military Medical Center

    San Antonio, Texas 78234
    United States

    Site Not Available

  • University Hospital

    San Antonio, Texas 78229
    United States

    Active - Recruiting

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