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NCT Number: NCT07659886

Implementation of Vancomycin Powder Application in the Emergency Department for Open Fractures

To evaluate the feasibility, safety, and potential efficacy of applying vancomycin powder locally to open fractures in the emergency department prior to definitive surgical intervention.

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Key information

Conditions

Open Fracture Fractures, Bone Fractures, Open Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Morristown Medical Center

Morristown, New Jersey, 07930, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Participants aged 18 years or older presenting to the Emergency Department with Gustilo-Anderson Type I, II, or III open fractures.

Exclusion criteria

  • Known allergy to vancomycin
  • Ballistic open fractures
  • Pregnancy
  • Currently breastfeeding
  • Age younger than 18 years.

Treatment and study plan

Vancomycin (VAN) treatment

Drug

A single 1-gram dose of sterile vancomycin powder is applied directly to the open fracture wound in the Emergency Department after initial wound assessment and irrigation and prior to definitive operative debridement and fixation.

Standard Open Fracture Care

Other

Standard management of open fractures according to institutional protocols, including intravenous antibiotics, wound care, irrigation, operative debridement, and fracture stabilization as indicated, without topical vancomycin powder application in the Emergency Department.

Primary outcomes

  1. Deep Surgical Site Infection

    Time frame: Defined as the proportion of participants who develop a deep surgical site infection involving the open fracture site within 90 days of injury or index operative treatment.

    Incidence of deep surgical site infection following open fracture treatment, defined according to Centers for Disease Control and Prevention (CDC)/National Healthcare Safety Network (NHSN) criteria and/or requiring operative irrigation and debridement or deep culture-directed antibiotic treatment.

Study contacts

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

Kristen De Wilde MD

CONTACT

[email protected]

201-572-9087

Sponsors and collaborators

Lead sponsor

Atlantic Health System

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Jun 22, 2026
Registry last updated
Jun 22, 2026

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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