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

NCT07659886 | Not Yet Recruiting Phase 3 FDA Drug

• 1 other identifier: 180742
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Open Fracture

Keywords

open fracture

Outcome Measures

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.

  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.

Study Arms (2)

Emergency Department Vancomycin Powder

EXPERIMENTAL

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

Standard Open Fracture Care

ACTIVE COMPARATOR

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

Other: Standard Open Fracture Care

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.

Emergency Department Vancomycin Powder

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.

Standard Open Fracture Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Atlantic Health System: lead

Study Sites (1)

Morristown Medical Center

Morristown, New Jersey, 07930, United States

Location

MeSH Terms

Conditions

Fractures, Open

Interventions

Vancomycin; Therapeutics

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins

Central Study Contacts

Kristen De Wilde MD

CONTACT

201-572-9087; kristen.dewilde@atlantichealth.org

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident physician

Study Record Dates

• First Submitted: June 8, 2026
• First Posted: June 22, 2026
• Study Start: June 10, 2026
• Primary Completion (Estimated): December 20, 2026
• Study Completion (Estimated): June 10, 2027
• Last Updated: June 22, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)