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

Part of paid clinical trials in Morristown, New Jersey.

Sponsor
Atlantic Health System
Study ID
NCT07659886
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

  • Open Fracture

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Jun 10, 2026
Status verified
Jun 2026
Primary completion
Dec 20, 2026
Completion
Jun 10, 2027

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Emergency Department Vancomycin Powder
    Patients receive 1 gram topical vancomycin powder applied to the open fracture wound in the Emergency Department in addition to standard open fracture management.
  • Active Comparator: Standard Open Fracture Care
    Patients receive standard open fracture management without Emergency Department (ED) vancomycin powder.

Primary Outcome Measure

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. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Morristown Medical CenterMorristownNew Jersey07930-

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Morristown Medical Center· Morristown, NJ

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