A Phase 4 interventional study of Vancomycin and Tobramycin in Fractures, Open, Wounds and Injuries--Infections and Anti-Bacterial Agents, sponsored by University of Colorado, Denver. Completed at 2 sites in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-03-06.
Sponsored by University of Colorado, Denver · Phase 4, Interventional, and Prevention
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.
53 studies on the registry are indexed under Fractures, Open; 14 are open to participants now.
This study's enrollment of 20 is below the median of 90 across 40 interventional studies indexed under Fractures, Open.
Browse Fractures, Open studies →University of Colorado, Denver is the lead sponsor of 1,543 studies on the registry; 317 are open to participants now.
Of its 147 completed or terminated interventional studies of FDA-regulated products, 92 (63%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects randomized to the Control Arm will receive standard of care open fracture wound care (no powder) by the clinical team.
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.
Drug: Vancomycin
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.
Drug: Tobramycin
1 vial of Vancomycin 1g powder applied topically to the open fracture wound injury.
1 vial of Tobramycin 1.2g powder applied topically to the open fracture wound injury.
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.
Time frame: Within 6 months of injury date
Presence of Fracture Nonunion
Understand the changes that occur in nonunion after antibiotic powder treatment .
Time frame: Within 1 year of injury date
| Milestone | Control | Vancomycin | Tobramycin |
|---|---|---|---|
| Started | 7 | 5 | 8 |
| Completed | 7 | 4 | 7 |
| Not completed | 0 | 1 | 1 |
The percentage of participants who develop an infection at the surgical site following debridement and fixation at the follow up period.
| participants | Control | Vancomycin | Tobramycin |
|---|---|---|---|
| Incidence of Surgical Site Infection During the Post-operative Follow-up Period | 0 | 0 | 0 |
Understand the changes that occur in nonunion after antibiotic powder treatment .
| Participants | Control | Vancomycin | Tobramycin |
|---|---|---|---|
| Presence of Fracture Nonunion | 1 | 1 | 1 |
Collected over From enrollment to minimum of 6 months after enrollment.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Control | 0/7 (0%) | 0/7 (0%) | 0/7 (0%) |
| Vancomycin | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) |
| Tobramycin | 0/7 (0%) | 0/7 (0%) | 0/7 (0%) |
This was randomized, one Vancomycin patient and one Tobramycin patient met exclusion criteria after study enrollment though. So they are excluded from Baseline Analysis.
| Age, Continuous(Years) | Control | Vancomycin | Tobramycin | Total |
|---|---|---|---|---|
| Mean | 46.71 ± 18.01 | 38.00 ± 11.60 | 46.14 ± 11.27 | 44.56 ± 14.80 |
| Sex: Female, Male(Participants) | Control | Vancomycin | Tobramycin | Total |
|---|---|---|---|---|
| Female | 1 | 1 | 4 | 6 |
| Male | 6 | 3 | 3 | 12 |
| Race (NIH/OMB)(Participants) | Control | Vancomycin | Tobramycin | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 1 | 0 | 1 |
| White | 5 | 2 | 6 | 13 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 2 | 1 | 1 | 4 |
| Ethnicity (NIH/OMB)(Participants) | Control | Vancomycin | Tobramycin | Total |
|---|---|---|---|---|
| Hispanic or Latino | 2 | 1 | 3 | 6 |
| Not Hispanic or Latino | 4 | 3 | 4 | 11 |
| Unknown or Not Reported | 1 | 0 | 0 | 1 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Vancomycin · Tobramycin
University of Colorado, Denver →