Open FracturePhase 4POWDERNCT03765567
Placement of Antibiotic Powder in Wounds During the Emergency Room
A Phase 4 study testing Vancomycin in people with Open Fracture, run by The University of Texas Health Science Center at San Antonio at 2 sites in United States.
Trial summary
This is the first prospective controlled study to determine whether the topical application of vancomycin powder reduces infection-related complications when applied to open fracture injuries in the acute emergency department setting. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Open Fracture
- What is being tested?
- Vancomycin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesUnited States
- Study dates
- 5 Oct 2020to Sep 2028
- Phase
- Phase 4
- 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 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject or Legal Authorized Representative (LAR) is willing and able to provide written informed consent.
- Adult 18 years of age or older.
- Open fracture of the humerus, radius, ulna, femur, tibia, and/or fibula.
- 24 hours or less has elapsed from the estimated time of injury to study intervention.
Who cannot join
- Time from injury > 24 hours.
- Subjects who have received acute operative care (e.g., washout in the operating room or fixation) of the open fracture at an outside facility.
- Subject or LAR speaks neither English nor Spanish. Note that subjects that are unable to participate in the consent process (e.g. intoxication, poly-trauma, will be enrolled into the observational arm where passive data collection will occur).
- High-potency antibiotic powder or solution applied to the wound prior to enrollment. Simple ointment (i.e., bacitracin ointment) or antibiotic-impregnated dressings will be permitted.
- Documented allergies or serious reactions to vancomycin. History of uncomplicated "red man syndrome" will not be considered a reason for exclusion.
- Pregnant subjects. If the subject is a female of childbearing potential, and she states that she is likely to be pregnant, a pregnancy test will be performed; if negative, the subject will be eligible for enrollment.
- Prisoners.
- Participation in other clinical research involving investigational antimicrobial products within 30 days of randomization.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
University Hospital
San Antonio, Texas, 78229
Robert DeLorenzo, MD, 210-567-4292, delorenzo@uthscsa.edu
Stephanie Martinez, 210 450-8566, martinezs13@uthscsa.edu
- Not yet recruiting
San Antonio Military Medical Center
San Antonio, Texas, 78234
Steven G Schauer, DO, steven.g.schauer.mil@mail.mil
Steven G Schauer, DO
About this study
Official title: Placement of Antibiotic Powder in Wounds During the Emergency Room (POWDER) Study
This is the first prospective controlled study to determine whether the topical application of vancomycin powder reduces infection-related complications when applied to open fracture injuries in the acute emergency department setting.
Read the detailed description
Open fracture injuries are highly susceptible to infection and infection-related complications. The current routine treatment for these injuries includes the use of systemic IV antibiotics. However, open fracture injuries often have compromised blood supply, reducing the amount of antibiotic that reaches the target tissue while increasing risk of injury to non-target organs. This trial aims to evaluate the effectiveness of early application of a topical vancomycin antibiotic powder on open fracture wounds, in combination with the usual treatment, in reducing the risk of infection seen in these injuries.
- Conditions
- Open Fracture
- Being tested
- Vancomycin
- Keywords
- infection, vancomycin, topical antibiotic, antibiotic prophylaxis
- Medical subject headings
- Fractures, Open, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VancomycinDrug
Also called NDC (National Drug Code) 67457-340-01, Topical vancomycin, Vancomycin powder
2 vials of Vancomycin 1g powder will be applied topically to the open fracture wound site.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | Subjects randomized to the Intervention Arm will receive usual care plus two (2) grams of Vancomycin powder administered topically. In the emergency room prior to surgical intervention, a qualified member of the study team or clinical team member will apply 2 grams of vancomycin powder directly to the open fracture site such that all visible surfaces of the wound are completely and uniformly covered, including bone edges. Receives: Drug: Vancomycin |
| Control Arm | No intervention | Subjects randomized to the Control Arm will receive usual care for open long bone fracture as determined by the treating physician. |
| Observational Arm | No intervention | Subjects who otherwise meet the criteria to be included in the study but are not able to provide consent, either themselves or through a Legally Authorized Representative, will be placed in the Observational Arm and receive usual care with no experimental intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Deep-space infection rate at prophylaxis site
The percentage of participants who develop an infection of the study open fracture requiring post-operative surgical intervention within one year of injury.
Measured: Within one year of injury date
Secondary outcomes (4)
Superficial infection rate requiring post-operative medical intervention
The percentage of participants who develop an infection of the study open fracture that requires post-operative medical intervention, including addition or change of antibiotic, bedside application of incision \& drainage, needle aspiration, and bedside application of a drain.
Measured: Within one year of injury date
Unplanned repeat visit rate
The percentage of participants who experience an unscheduled medical encounter related to open fracture-site infection.
Measured: Within one year of injury date
Readmission rate for open fracture infection
The percentage of participants who are readmitted to the hospital due to infection or complication of the study open fracture. Included in this assessment is sepsis and sepsis-related conditions arising from an open fracture infection.
Measured: Within one year of injury date
Death rate
The rate of death among participants from presumed or documented open fracture site infection, determined by documentation through reliable diagnostic means.
Measured: Within one 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 posted5 Dec 2018
- Study start5 Oct 2020
- Primary completionSep 2027 (estimated)
- Study completionSep 2028 (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.
- More trials run by The University of Texas Health Science Center at San AntonioThe 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
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- United States Army Institute of Surgical Research, San Antonio Military Medical Center
- Responsible party
- Sponsor
- Investigators
- Robert A De Lorenzo, MD, Principal investigator, University of Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03765567
- Sponsor's protocol ID
- HSC20180520H
- Other IDs
- W81XWH-18-2-0074
- Acronym
- POWDER
- Status last verified
- Sep 2026
- First submitted
- 4 Dec 2018
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared through the use of the REDCap Web-based distributed data collection system. All sharing of data will conform to currently established DOD HRPO (Department of Defense Human Research Protection Office) human subject protection practices and will be in compliance with all appropriate state and federal confidentiality requirements and privacy guidelines.
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Placement of Antibiotic Powder in Wounds During the Emergency Room (POWDER) Study
- ClinicalTrials.gov ID
- NCT03765567
- Acronym / sponsor ID
- POWDER / HSC20180520H
- Conditions
- Open Fracture
- Keywords
- infection, vancomycin, topical antibiotic, antibiotic prophylaxis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Collaborators
- United States Army Institute of Surgical Research, San Antonio Military Medical Center
- Study start
- 5 Oct 2020 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 5 Dec 2018 (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.
This is the first prospective controlled study to determine whether the topical application of vancomycin powder reduces infection-related complications when applied to open fracture injuries in the acute emergency department setting.
Detailed description
Open fracture injuries are highly susceptible to infection and infection-related complications. The current routine treatment for these injuries includes the use of systemic IV antibiotics. However, open fracture injuries often have compromised blood supply, reducing the amount of antibiotic that reaches the target tissue while increasing risk of injury to non-target organs. This trial aims to evaluate the effectiveness of early application of a topical vancomycin antibiotic powder on open fracture wounds, in combination with the usual treatment, in reducing the risk of infection seen in these injuries.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Drug: VancomycinSubjects randomized to the Intervention Arm will receive usual care plus two (2) grams of Vancomycin powder administered topically. In the emergency room prior to surgical intervention, a qualified member of the study team or clinical team member will apply 2 grams of vancomycin powder directly to the open fracture site such that all visible surfaces of the wound are completely and uniformly covered, including bone edges. |
| Control Arm | No intervention | –Subjects randomized to the Control Arm will receive usual care for open long bone fracture as determined by the treating physician. |
| Observational Arm | No intervention | –Subjects who otherwise meet the criteria to be included in the study but are not able to provide consent, either themselves or through a Legally Authorized Representative, will be placed in the Observational Arm and receive usual care with no experimental intervention. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subject or Legal Authorized Representative (LAR) is willing and able to provide written informed consent.
- Adult 18 years of age or older.
- Open fracture of the humerus, radius, ulna, femur, tibia, and/or fibula.
- 24 hours or less has elapsed from the estimated time of injury to study intervention.
Key exclusion criteria (8 listed)
- Time from injury > 24 hours.
- Subjects who have received acute operative care (e.g., washout in the operating room or fixation) of the open fracture at an outside facility.
- Subject or LAR speaks neither English nor Spanish. Note that subjects that are unable to participate in the consent process (e.g. intoxication, poly-trauma, will be enrolled into the observational arm where passive data collection will occur).
- High-potency antibiotic powder or solution applied to the wound prior to enrollment. Simple ointment (i.e., bacitracin ointment) or antibiotic-impregnated dressings will be permitted.
- Documented allergies or serious reactions to vancomycin. History of uncomplicated "red man syndrome" will not be considered a reason for exclusion.
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 |
|---|---|---|
| VancomycinAlso: NDC (National Drug Code) 67457-340-01, Topical vancomycin, Vancomycin powder2 vials of Vancomycin 1g powder will be applied topically to the open fracture wound site. | Drug | Intervention Arm |
Primary outcome
Deep-space infection rate at prophylaxis site
Time frame: Within one year of injury date
The percentage of participants who develop an infection of the study open fracture requiring post-operative surgical intervention within one year of injury.
4 secondary outcomes
Superficial infection rate requiring post-operative medical intervention
Time frame: Within one year of injury date
Unplanned repeat visit rate
Time frame: Within one year of injury date
Readmission rate for open fracture infection
Time frame: Within one year of injury date
Death rate
Time frame: Within one year of injury date
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 30 Sep 2026.
- Individual participant dataSharing planned: Yes. Data will be shared through the use of the REDCap Web-based distributed data collection system. All sharing of data will conform to currently established DOD HRPO (Department of Defense Human Research Protection Office) human subject protection practices and will be in compliance with all appropriate state and federal confidentiality requirements and privacy guidelines.
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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.
Robert A De Lorenzo, MD principal investigator
University of Texas
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 in people with Open Fracture, run by The University of Texas Health Science Center at San Antonio 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 8 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: looking for participants now, as of the sponsor's last update on 30 Sep 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?
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 Robert A De Lorenzo, MD (210-567-0056, DeLorenzo@uthscsa.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Deep-space infection rate at prophylaxis site (time frame: Within one year 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 30 Sep 2026.