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Not yet recruitingNCT07659886Updated Jun 22, 2026

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

A Phase 3 interventional study of Vancomycin (VAN) treatment and Standard Open Fracture Care in Open Fracture, sponsored by Atlantic Health System. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-22.

Sponsored by Atlantic Health System · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Open Fracture

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Keywords

  • open fracture
03

In context

Fractures, Open

53 studies on the registry are indexed under Fractures, Open; 14 are open to participants now.

This study's planned enrollment of 100 is above the median of 90 across 40 interventional studies indexed under Fractures, Open.

Browse Fractures, Open studies →

Lead sponsor

Atlantic Health System is the lead sponsor of 64 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Known allergy to vancomycin
  • Ballistic open fractures
  • Pregnancy
  • Currently breastfeeding
  • Age younger than 18 years.
05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (estimated)

Study 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.

    Drug: Vancomycin (VAN) treatment

  • Active comparator
    Standard Open Fracture Care

    Patients receive standard open fracture management without Emergency Department (ED) vancomycin powder.

    Other: Standard Open Fracture Care

Interventions

  • DrugVancomycin (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.

  • OtherStandard 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.

06

What researchers measure

Primary outcomes

  1. Deep Surgical Site Infection

    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.

    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.

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No — Data will be collected and stored locally, de-identified, and deleted after study completion

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07659886
Lead sponsor
Atlantic Health System
Responsible party
Kristen De Wilde (Resident physician, Atlantic Health System) — Principal investigator
First posted
Jun 22, 2026
Start date
Jun 10, 2026 (estimated)
Primary completion
Dec 20, 2026 (estimated)
Completion
Jun 10, 2027 (estimated)
Last update
Jun 22, 2026

Study contacts

Kristen De Wilde MD
Contact
kristen.dewilde@atlantichealth.org
201-572-9087

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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