Fractures, OpenPhase 3NCT03705962
Locally Applied Antibiotics for Infection Prophylaxis in Treatment of Open Fractures
A Phase 3 study testing Tobramycin in people with Fractures, Open, run by University of Virginia at 1 site in United States.
Trial summary
The primary objective of this study is to investigate the effectiveness of local antibiotic versus placebo in the prevention of infections in open fractures. The study will assess whether local treatment of open fractures with the antibiotic tobramycin (in addition to standard systemic antibiotics) will decrease the… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Fractures, Open
- What is being tested?
- Tobramycin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to 7 Mar 2019
- Phase
- Phase 3
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ages 18 - 70 years
- Gustilo Type I,II,IIIa open fracture (s)
- Ability to provide informed consent (or proxy consent in cases where subject is temporarily impaired when intubated and sedated)
- Subject should be able to follow up at the scheduled times following surgery
- Subjects who may have compartment syndrome, renal insufficiency, and those who are immunosuppressed regardless of antibiotic administration will also be included in the study
Who cannot join
- Closed fracture
- Severe injury requiring flap coverage or vascular reconstruction (Gustilo-Anderson Type IIIB and C respectively)
- Aminoglycoside allergy
- Presentation greater than 48 hours after injury
- Pathologic fracture
- Preexisting infection in bone with an open fracture
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- Patients with multiple trauma involving liver, kidney, or brain
- Pregnancy (self-reported)
- Current status as prisoner
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia Medical Center
Charlottesville, Virginia, 22908
About this study
The primary objective of this study is to investigate the effectiveness of local antibiotic versus placebo in the prevention of infections in open fractures. The study will assess whether local treatment of open fractures with the antibiotic tobramycin (in addition to standard systemic antibiotics) will decrease the risk and rate of infection, and rate of re-operation. This will be studied using a randomized controlled clinical trial design in adult population of age 18-70 years who present with open fractures. About 133 subjects will be recruited in this study at UVA.
- Conditions
- Fractures, Open
- Being tested
- Tobramycin, Placebo: normal saline
- Medical subject headings
- Fractures, Open
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TobramycinDrug
Placebo: normal salineOther
| Study group | Role | What they receive |
|---|---|---|
| Antibiotic | Experimental | Subjects will be injected locally at the wound cavity (i.e. fracture site, surrounding soft tissue which include muscle, and subcutaneous space) with 80mg/40mL of tobramycin after wound closure. Systemic antibiotic will not be withheld and will be done along side the intervention. Receives: Drug: Tobramycin |
| Normal Saline | Placebo comparator | Subjects will be injected locally with 40 mL 0.9% NS after wound closure. Systemic antibiotic will not be withheld and will be done along side the intervention. Receives: Other: Placebo: normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of Wound Infection
Infection will be defined as major and minor, with major indicated by return to the operating room for irrigation and debridement. Minor infection is represented by documentation of cellulitis or superficial infection at surgical site and administration of oral antibiotics
Measured: 6 weeks post op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2018
- Study startJul 2015
- Primary completion7 Mar 2019
- Study completion7 Mar 2019
Why it stopped: Unable to continue study due to funding and personnel restraints
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 VirginiaThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seth Yarboro, MD, University of Virginia
- Investigators
- Seth Yarboro, MD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03705962
- Sponsor's protocol ID
- 18088
- Status last verified
- May 2023
- First submitted
- 12 May 2016
- Last updated
- 15 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Locally Applied Antibiotics for Infection Prophylaxis in Treatment of Open Fractures
- ClinicalTrials.gov ID
- NCT03705962
- Acronym / sponsor ID
- 18088
- Conditions
- Fractures, Open
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to continue study due to funding and personnel restraints
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- Jul 2015 (actual)
- Primary completion
- 7 Mar 2019 (actual)
- Study completion
- 7 Mar 2019 (actual)
- First posted
- 15 Oct 2018 (actual)
- Results
- Posted 15 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to investigate the effectiveness of local antibiotic versus placebo in the prevention of infections in open fractures. The study will assess whether local treatment of open fractures with the antibiotic tobramycin (in addition to standard systemic antibiotics) will decrease the risk and rate of infection, and rate of re-operation. This will be studied using a randomized controlled clinical trial design in adult population of age 18-70 years who present with open fractures. About 133 subjects will be recruited in this study at UVA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Antibiotic | Experimental | Drug: TobramycinSubjects will be injected locally at the wound cavity (i.e. fracture site, surrounding soft tissue which include muscle, and subcutaneous space) with 80mg/40mL of tobramycin after wound closure. Systemic antibiotic will not be withheld and will be done along side the intervention. |
| Normal Saline | Placebo comparator | Other: Placebo: normal salineSubjects will be injected locally with 40 mL 0.9% NS after wound closure. Systemic antibiotic will not be withheld and will be done along side the intervention. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Ages 18 - 70 years
- Gustilo Type I,II,IIIa open fracture (s)
- Ability to provide informed consent (or proxy consent in cases where subject is temporarily impaired when intubated and sedated)
- Subject should be able to follow up at the scheduled times following surgery
- Subjects who may have compartment syndrome, renal insufficiency, and those who are immunosuppressed regardless of antibiotic administration will also be included in the study
Key exclusion criteria (9 listed)
- Closed fracture
- Severe injury requiring flap coverage or vascular reconstruction (Gustilo-Anderson Type IIIB and C respectively)
- Aminoglycoside allergy
- Presentation greater than 48 hours after injury
- Pathologic fracture
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 |
|---|---|---|
| Tobramycin | Drug | Antibiotic |
| Placebo: normal saline | Other | Normal Saline |
Primary outcome
Presence of Wound Infection
Time frame: 6 weeks post op
Infection will be defined as major and minor, with major indicated by return to the operating room for irrigation and debridement. Minor infection is represented by documentation of cellulitis or superficial infection at surgical site and administration of oral antibiotics
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Seth Yarboro, MD principal investigator
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tobramycin in people with Fractures, Open, run by University of Virginia at 1 site 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 5 inclusion and 9 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: stopped early, as of the sponsor's last update on 15 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 15 Jun 2023). 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?
Presence of Wound Infection (time frame: 6 weeks post op). 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 15 Jun 2023.