Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Standard Open Fracture Care | Active Comparator | Patients receive standard open fracture management without Emergency Department (ED) vancomycin powder. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kristen De Wilde MD | Contact | 201-572-9087 | kristen.dewilde@atlantichealth.org |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Morristown Medical Center | Morristown | New Jersey | 07930 | United States |
Data will be collected and stored locally, de-identified, and deleted after study completion
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D005597 | Fractures, Open |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
Not provided
Not provided
| ID | Term |
|---|---|
| D014640 | Vancomycin |
| D013812 | Therapeutics |
| ID | Term |
|---|---|
| D006020 | Glycopeptides |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D010455 | Peptides |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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. |
|
| D000602 |
| Amino Acids, Peptides, and Proteins |