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Not yet recruiting NCT07659886

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

Phase III Interventional Open Fracture

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Vancomycin (VAN) treatment, Standard Open Fracture Care.
Who it may be relevant to
Registry conditions: Open Fracture. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Interventions

  • Drug Vancomycin (VAN) treatment
    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.
  • Other Standard Open Fracture Care
    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 outcome measures

  • 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.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

United States · 1 center
  • Morristown Medical Center — Morristown

Identifiers

NCT: NCT07659886 · 180742

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗