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NCT Number: NCT03765567

Placement of Antibiotic Powder in Wounds During the Emergency Room

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.

Recruiting

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Key information

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

San Antonio Military Medical Center, San Antonio, Texas, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.
  • 24 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.

Treatment and study plan

Vancomycin

Drug

2 vials of Vancomycin 1g powder will be applied topically to the open fracture wound site.

Other names: NDC (National Drug Code) 67457-340-01, Topical vancomycin, Vancomycin powder

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Robert A De Lorenzo, MD

CONTACT

[email protected]

210-567-0056

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center at San Antonio

Other

Collaborators

  • San Antonio Military Medical Center
  • United States Army Institute of Surgical Research

Registry information

Official study title

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

Acronym: POWDER

Important dates

Study start
2020
Primary completion
2026
Study completion
2027
First posted
Dec 5, 2018
Registry last updated
Aug 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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