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| ID | Type | Description | Link |
|---|---|---|---|
| 5672 | Other Grant/Funding Number | Orthopaedic Trauma Association |
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| Name | Class |
|---|---|
| Denver Health and Hospital Authority | OTHER |
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The purpose of this study is to help determine the best treatment for severe injures like open fracture wounds.
Some broken bone injuries can be more likely to get an infection. It is mostly due to the way they were injured. Surgical site infection in the orthopedic surgery population is a big public health issue. Wound infections result in both longer length of hospital stay and total cost of care. This study will be using an antibiotic called Vancomycin or Tobramycin in a powder form.
The investigators aim to investigate the effectiveness of preoperative intrawound antibiotic powder in preventing infection and reducing bacterial burden after open fracture.
The investigators hypothesize that the participants who receive preoperative intrawound antibiotic powder will have fewer superficial and deep surgical site infections compared to participants who do not receive the antibiotic powder. The investigators also anticipate that the application of the antibiotic powder to open fracture wounds preoperatively will decrease the bacterial burden.
Sample swabs will be analyzed using the 16S metagenomics sequencing on the Illumina platform. Both RNA and DNA extracts will be utilized to identify and quantify the bacterial load in the wound bed at the time immediately prior to surgical debridement.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | Subjects randomized to the Control Arm will receive standard of care open fracture wound care (no powder) by the clinical team. | |
| Vancomycin | Experimental | Subjects randomized to the Intervention arm will receive standard of care plus 1 gram of vancomycin powder applied topically to the wound bed before the dressing is applied. Intervention will occur in the emergency room prior to surgical intervention. |
|
| Tobramycin | Experimental | Subjects randomized to the Intervention arm will receive standard of care plus 1.2 grams of tobramycin powder applied topically to the wound bed before the dressing is applied. Intervention will occur in the emergency room prior to surgical intervention. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vancomycin | Drug | 1 vial of Vancomycin 1g powder applied topically to the open fracture wound injury. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Surgical Site Infection During the Post-operative Follow-up Period | The percentage of participants who develop an infection at the surgical site following debridement and fixation at the follow up period. | Within 6 months of injury date |
| Measure | Description | Time Frame |
|---|---|---|
| Presence of Fracture Nonunion | Understand the changes that occur in nonunion after antibiotic powder treatment . | Within 1 year of injury date |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nicholas Alfonso, MD | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Anschutz | Aurora | Colorado | 80045 | United States | ||
| Denver Health and Hospital Authority |
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| ID | Title | Description |
|---|---|---|
| FG000 | Control | Subjects randomized to the Control Arm will receive standard of care open fracture wound care (no powder) by the clinical team. |
| FG001 | Vancomycin | Subjects randomized to the Intervention arm will receive standard of care plus 1 gram of vancomycin powder applied topically to the wound bed before the dressing is applied. Intervention will occur in the emergency room prior to surgical intervention. |
| FG002 | Tobramycin | Subjects randomized to the Intervention arm will receive standard of care plus 1.2 grams of tobramycin powder applied topically to the wound bed before the dressing is applied. Intervention will occur in the emergency room prior to surgical intervention. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
This was randomized, one Vancomycin patient and one Tobramycin patient met exclusion criteria after study enrollment though. So they are excluded from Baseline Analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | Control | Subjects randomized to the Control Arm will receive standard of care open fracture wound care (no powder) by the clinical team. |
| BG001 | Vancomycin | Subjects randomized to the Intervention arm will receive standard of care plus 1 gram of vancomycin powder applied topically to the wound bed before the dressing is applied. Intervention will occur in the emergency room prior to surgical intervention. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Incidence of Surgical Site Infection During the Post-operative Follow-up Period | The percentage of participants who develop an infection at the surgical site following debridement and fixation at the follow up period. | Posted | Number | participants | Within 6 months of injury date |
|
From enrollment to minimum of 6 months after enrollment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control | Subjects randomized to the Control Arm will receive standard of care open fracture wound care (no powder) by the clinical team. |
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Study limitations included a small sample size, preventing statistical significance testing between arms. Patient follow-up was hindered by geographic distance from the trauma center. Variations in fracture patterns and size led to potential inconsistencies in antibiotic powder administration and swabbing techniques (e.g., skin flora contamination). Future studies require larger cohorts to confirm the efficacy of local antibiotic powder in orthopedic trauma.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nicholas Alfonso, M.D., Principal Investigator | University of Colorado - Anschutz Medical Campus | 303-724-1055 | nicholas.alfonso@cuanschutz.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 5, 2021 | Feb 12, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D005597 | Fractures, Open |
| D014947 | Wounds and Injuries |
| D050723 | Fractures, Bone |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D014640 | Vancomycin |
| D014031 | Tobramycin |
| ID | Term |
|---|---|
| D006020 | Glycopeptides |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D010455 | Peptides |
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The management of open fractures involves an expedited administration of systemic antibiotics and while effective in reducing the rate of infection, complications from infections are still common following open fractures. This trial aims to evaluate the incidence of surgical site infections using topical vancomycin antibiotic powder or topical tobramycin antibiotic powder in combination with standard of care treatment and to evaluate the effectiveness of both topical antibiotic powders in reducing surgical site infection.
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This will be a single-blind study as only the participants will be blinded to the treatment.
| Tobramycin | Drug | 1 vial of Tobramycin 1.2g powder applied topically to the open fracture wound injury. |
|
| Denver |
| Colorado |
| 80204 |
| United States |
| BG002 | Tobramycin | Subjects randomized to the Intervention arm will receive standard of care plus 1.2 grams of tobramycin powder applied topically to the wound bed before the dressing is applied. Intervention will occur in the emergency room prior to surgical intervention. |
| BG003 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| OG002 | Tobramycin | Subjects randomized to the Intervention arm will receive standard of care plus 1.2 grams of tobramycin powder applied topically to the wound bed before the dressing is applied. Intervention will occur in the emergency room prior to surgical intervention. |
|
|
| Secondary | Presence of Fracture Nonunion | Understand the changes that occur in nonunion after antibiotic powder treatment . | Posted | Count of Participants | Participants | Within 1 year of injury date |
|
|
|
| 0 |
| 7 |
| 0 |
| 7 |
| 0 |
| 7 |
| EG001 | Vancomycin | Subjects randomized to the Intervention arm will receive standard of care plus 1 gram of vancomycin powder applied topically to the wound bed before the dressing is applied. Intervention will occur in the emergency room prior to surgical intervention. | 0 | 4 | 0 | 4 | 0 | 4 |
| EG002 | Tobramycin | Subjects randomized to the Intervention arm will receive standard of care plus 1.2 grams of tobramycin powder applied topically to the wound bed before the dressing is applied. Intervention will occur in the emergency room prior to surgical intervention. | 0 | 7 | 0 | 7 | 0 | 7 |
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| D000602 |
| Amino Acids, Peptides, and Proteins |
| D009328 | Nebramycin |
| D007612 | Kanamycin |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |