Open FracturePhase 3NCT07659886
Implementation of Vancomycin Powder Application in the Emergency Department for Open Fractures
A Phase 3 study testing Vancomycin (VAN) treatment and Standard Open Fracture Care in people with Open Fracture, run by Atlantic Health System at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Open Fracture
- What is being tested?
- Vancomycin (VAN) treatment and Standard Open Fracture Care
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jun 2026to 10 Jun 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants aged 18 years or older presenting to the Emergency Department with Gustilo-Anderson Type I, II, or III open fractures.
Who cannot join
- Known allergy to vancomycin
- Ballistic open fractures
- Pregnancy
- Currently breastfeeding
- Age younger than 18 years.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Morristown Medical Center
Morristown, New Jersey, 07930
About this study
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
- Being tested
- Vancomycin (VAN) treatment, Standard Open Fracture Care
- Keywords
- open fracture
- Medical subject headings
- Fractures, Open
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vancomycin (VAN) treatmentDrug
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 CareOther
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Vancomycin (VAN) treatment |
| Standard Open Fracture Care | Active comparator | Patients receive standard open fracture management without Emergency Department (ED) vancomycin powder. Receives: Other: Standard Open Fracture Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2026
- Study start10 Jun 2026 (estimated)
- Primary completion20 Dec 2026 (estimated)
- Study completion10 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Open FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Atlantic Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kristen De Wilde, Atlantic Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07659886
- Sponsor's protocol ID
- 180742
- Status last verified
- Jun 2026
- First submitted
- 8 Jun 2026
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be collected and stored locally, de-identified, and deleted after study completion
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of Vancomycin Powder Application in the Emergency Department for Open Fractures
- ClinicalTrials.gov ID
- NCT07659886
- Acronym / sponsor ID
- 180742
- Conditions
- Open Fracture
- Keywords
- open fracture
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Atlantic Health SystemUniversity, hospital or other
- Study start
- 10 Jun 2026 (estimated)
- Primary completion
- 20 Dec 2026 (estimated)
- Study completion
- 10 Jun 2027 (estimated)
- First posted
- 22 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Emergency Department Vancomycin Powder | Experimental | Drug: Vancomycin (VAN) treatmentPatients receive 1 gram topical vancomycin powder applied to the open fracture wound in the Emergency Department in addition to standard open fracture management. |
| Standard Open Fracture Care | Active comparator | Other: Standard Open Fracture CarePatients receive standard open fracture management without Emergency Department (ED) vancomycin powder. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Participants aged 18 years or older presenting to the Emergency Department with Gustilo-Anderson Type I, II, or III open fractures.
Key exclusion criteria (5 listed)
- Known allergy to vancomycin
- Ballistic open fractures
- Pregnancy
- Currently breastfeeding
- Age younger than 18 years.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vancomycin (VAN) treatmentA 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. | Drug | Emergency Department Vancomycin Powder |
| Standard Open Fracture CareStandard 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. | Other | Standard Open Fracture Care |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Individual participant dataSharing planned: No. Data will be collected and stored locally, de-identified, and deleted after study completion
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Vancomycin (VAN) treatment and Standard Open Fracture Care in people with Open Fracture, run by Atlantic Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kristen De Wilde MD (201-572-9087, kristen.dewilde@atlantichealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026.