Fractures, OpenPhase 4APOWNCT04872400
Acute Application of Antibiotic Powder in Open Fracture Wounds
A Phase 4 study testing Vancomycin and Tobramycin in people with Fractures, Open and Wounds and Injuries--Infections, run by University of Colorado, Denver at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Fractures, Open, Wounds and Injuries--Infections, Anti-Bacterial Agents
- What is being tested?
- Vancomycin and Tobramycin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- 14 Jun 2021to 30 Sep 2023
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject or proxy willing and able to provide written informed consent.
- Age between 18 years and 80 years (inclusive), with an upper or lower extremity Gustilo Type II, IIIA, or IIIB open fractures requiring debridement and internal fixation.
- Open extremity fractures
- Time from injury to study intervention 24 hours or less
Who cannot join
- Individuals under the age of 18 years or over 80 years
- Type I or IIIC open fractures
- Over 24 hours from time of injury
- Subjects who have received acute operative care of the open fracture at an outside facility prior to presenting at the Emergency Department.
- Open fractures distal to the wrist and midfoot
- History of chronic infection in the extremity involved.
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- Subjects who are currently pregnant
- Subjects who are Prisoners
- Subjects with a known allergy to vancomycin or tobramycin
- Subjects with a condition or social circumstances that would reduce adherence and follow-up.
- Subjects Participating in other clinical research involving investigational antimicrobial products within 30 days of randomization.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Colorado Anschutz
Aurora, Colorado, 80045
Denver Health and Hospital Authority
Denver, Colorado, 80204
About this study
Official title: Acute Application Of Intrawound Antibiotic Powder In Open Extremity Fracture Wounds
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.
Read the detailed description
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.
- Conditions
- Fractures, Open, Wounds and Injuries--Infections, Anti-Bacterial Agents, Fractures, Bone, Extremity Fracture Lower, Extremity Fractures Upper
- Being tested
- Vancomycin, Tobramycin
- Keywords
- Open fractures, Antibiotic powder, Vancomycin, Tobramycin, Infection, Gustilo, 16S
- Medical subject headings
- Fractures, Open, Wounds and Injuries, Fractures, Bone, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VancomycinDrug
1 vial of Vancomycin 1g powder applied topically to the open fracture wound injury.
TobramycinDrug
1 vial of Tobramycin 1.2g powder applied topically to the open fracture wound injury.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Vancomycin |
| 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. Receives: Drug: Tobramycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 6 months of injury date
Secondary outcomes (1)
Presence of Fracture Nonunion
Understand the changes that occur in nonunion after antibiotic powder treatment .
Measured: Within 1 year of injury date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2021
- Study start14 Jun 2021
- Primary completion30 Sep 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Fractures, OpenStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Denver Health and Hospital Authority
- Responsible party
- Sponsor
- Investigators
- Nicholas Alfonso, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04872400
- Sponsor's protocol ID
- 20-2957
- Other IDs
- 5672
- Acronym
- APOW
- Status last verified
- Feb 2026
- First submitted
- 29 Apr 2021
- Last updated
- 6 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Application Of Intrawound Antibiotic Powder In Open Extremity Fracture Wounds
- ClinicalTrials.gov ID
- NCT04872400
- Acronym / sponsor ID
- APOW / 20-2957
- Conditions
- Fractures, Open, Wounds and Injuries--Infections, Anti-Bacterial Agents, Fractures, Bone, Extremity Fracture Lower, Extremity Fractures Upper
- Keywords
- Open fractures, Antibiotic powder, Vancomycin, Tobramycin, Infection, Gustilo, 16S
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Denver Health and Hospital Authority
- Study start
- 14 Jun 2021 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 4 May 2021 (actual)
- Results
- Posted 6 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Drug: VancomycinSubjects 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 | Drug: TobramycinSubjects 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subject or proxy willing and able to provide written informed consent.
- Age between 18 years and 80 years (inclusive), with an upper or lower extremity Gustilo Type II, IIIA, or IIIB open fractures requiring debridement and internal fixation.
- Open extremity fractures
- Time from injury to study intervention 24 hours or less
Key exclusion criteria (11 listed)
- Individuals under the age of 18 years or over 80 years
- Type I or IIIC open fractures
- Over 24 hours from time of injury
- Subjects who have received acute operative care of the open fracture at an outside facility prior to presenting at the Emergency Department.
- Open fractures distal to the wrist and midfoot
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 |
|---|---|---|
| Vancomycin1 vial of Vancomycin 1g powder applied topically to the open fracture wound injury. | Drug | Vancomycin |
| Tobramycin1 vial of Tobramycin 1.2g powder applied topically to the open fracture wound injury. | Drug | Tobramycin |
Primary outcome
Incidence of Surgical Site Infection During the Post-operative Follow-up Period
Time frame: Within 6 months of injury date
The percentage of participants who develop an infection at the surgical site following debridement and fixation at the follow up period.
1 secondary outcome
Presence of Fracture Nonunion
Time frame: Within 1 year of injury date
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Nicholas Alfonso, MD principal investigator
University of Colorado, Denver
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vancomycin and Tobramycin in people with Fractures, Open and Wounds and Injuries--Infections, run by University of Colorado, Denver at 2 sites 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 4 inclusion and 11 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: finished, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Surgical Site Infection During the Post-operative Follow-up Period (time frame: Within 6 months of injury date). 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 6 Mar 2026.