InfectionsEarly Phase 1NCT05849090
Vancomycin and Tobramycin Powder Use in Acute Open Fractures
A Early Phase 1 study testing Cephalosporin or clindamycin/vancomycin antibiotics.. and Vancomycin and Tobramycin antibiotics. in people with Infections, run by University of Utah at 1 site in United States.
Trial summary
The investigators overall aim of this study is to determine the difference in 6-month infection rates in patients treated with the combined vancomycin and tobramycin (VT) powder compared to the standard of care (SC). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Infections
- What is being tested?
- Cephalosporin or clindamycin/vancomycin antibiotics.. and Vancomycin and Tobramycin antibiotics.
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Mar 2023to 12 Dec 2024
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Open fracture GA class II or III, and one of the following fracture locations:
- Calcaneus fracture,
- Tibial plafond (pilon) fracture,
- Tibial plateau fracture,
- Tibial shaft fracture,
- Distal femur fracture,
Show all 9Show fewer
- Femoral shaft fracture.
- Informed consent can be obtained from the patient.
- Consent will be obtained in the Emergency Department.
Who cannot join
- Known allergy to vancomycin or tobramycin.
- Known kidney disease prior to admission, chronic Kidney Disease stage 4 -5.
- Any patients, family members, or staff who refuse to participate.
- Pregnant women, as identified through pregnancy test which is taken in the emergency department as standard of care.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Utah Orthopaedic Center
Salt Lake City, Utah, 84112
About this study
Official title: Pilot for Vancomycin and Tobramycin Powder Use in Acute Open Fractures in the Emergency Department
The investigators overall aim of this study is to determine the difference in 6-month infection rates in patients treated with the combined vancomycin and tobramycin (VT) powder compared to the standard of care (SC).
In order to evaluate this objective, the investigators propose the following specific aims for the pilot study:
Read more
Specific Aim 1: Assess VT and SC patient enrollment, randomization and early clinical follow-up. Hypothesis: This study will successfully enroll and randomize 50 patients, 25 into each treatment group and will achieve 85% clinical follow-up at 6-months post-ED admission date.
Open fracture patients/families that meet study inclusion/exclusion criteria will be approached by a study team member for informed consent. After providing consent, patients will be appropriately randomized to either VT or SC treatment. Patients will be clinically followed at regular intervals up to 6 months post-surgery. Enrollment, appropriate randomization and surgical allocation, and clinical follow-up will be evaluated.
Specific Aim 2: Compare infection rates, cultures and patient characteristics between groups. Hypothesis: VT will have a lower infection rate than the SC group. Additionally, randomization will create an equal distribution of patient demographics as well as fracture severity and soft tissue damage, as classified by the Gustilo-Anderson Classification System (GA).
Specific Aim 3: Compare local wound healing and fracture healing between VT group and SC group. Hypothesis: VT will have less rates of wound healing complications due to decreased infections. No local wound irritation or wound closure issues will be seen between groups. There will be no difference in fracture healing between groups.
Read the detailed description
Open limb fractures are severe orthopedic injuries and at an increased risk for complications including nonunion and infection. Rates of infection are dependent upon features such as extent of soft tissue trauma, patient characteristics, degree of contamination and modifiable factors such as time to surgical debridement and IV (intravenous) antibiotics. Surgical debridement within 24 hours and IV antibiotics are the current standard of care, but despite advances in care, the infection rates for these injuries has remained stable over the last several decades.
Possible explanations for this stagnation in care may be related to the current standard of care and the pathophysiology of open fractures. There is significant soft-tissue damage in open fractures, which compromises local vasculature leading to devascularized soft tissue and bone. This devitalized tissue serves as a nidus for infection, a base for biofilm production and reduces the level of systemic antibiotics delivered to the zone of injury. Local antibiotic therapy has the potential to overcome these challenges, by allowing a high concentration of antibiotics to be delivered to the devitalized tissue. Additional benefits of local antibiotics are their powdered form, which is stable, easy to transport, and can be applied immediately in austere situations without the need for IV access. A recent randomized control trial found a 4% decrease risk of infection following powdered vancomycin placement at the time of hardware fixation. However, a recent meta-analysis showed nearly a 12% risk reduction in open fractures treated with local antibiotics when compared to the standard of care. However, this meta-analysis was predominantly made up of small retrospective studies, underlying the need for a randomized control trial evaluating the efficacy of local antibiotics in acute open fracture management.
While causative organisms vary with location, cultures from open fractures are positive 83% of the time. Cultures have shown high rates of colonization of both gram-positive organisms (predominantly Staphylococcus aureus and epidermidis) as well as gram-negative organisms (mostly Pseudomonaonas aeruginosa). Given this prevalence the antibiotics vancomycin and tobramycin are likely good candidates given that they have high efficacy against the common colonizing bacteria, are available in standardize powdered formula, reach high local concentrations, and have a minimal cytotoxic effect to local cells6. Using a combination of vancomycin and tobramycin in the acute care of severe open fractures may substantially decrease risks of infection from both gram-positive and gram-negative pathogens.
- Conditions
- Infections
- Being tested
- Cephalosporin or clindamycin/vancomycin antibiotics.., Vancomycin and Tobramycin antibiotics.
- Keywords
- Infections, Acute open fractures, Standard of care prophylactic antibiotics, Vancomycin and Tobramycin powder
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cephalosporin or clindamycin/vancomycin antibiotics..Drug
Also called Cephalosporin - Cefazolin, (Ancef, Kefzol, Cefacidil), Cephalosporin- Ceftriaxone, (Ceftrisol Plus, Rocephin), Clindamycin, (Cleocin, Clindesse), Vancomycin, (Vancocin)
Antibiotics: Cephalosporin, 2-grams, intravenous (IV), or clindamycin (900mg) / vancomycin (20mg/kg), intravenous (IV).
Vancomycin and Tobramycin antibiotics.Drug
Also called Vancomycin, (Vancocin), Tobramycin, (Tobi, Tobrex, Nebcin)
Vancomycin (1 gram) and tobramycin (1.2 grams).
| Study group | Role | What they receive |
|---|---|---|
| Standard of care prophylactic antibiotics | Active comparator | Standard irrigation and IV, cephalosporin, 2-grams, intravenous (IV),
* or standard irrigation and IV, clindamycin (900mg) / vancomycin (20mg/kg), intravenous (IV) for patients with cephalosporin allergies. Receives: Drug: Cephalosporin or clindamycin/vancomycin antibiotics.. |
| Vancomycin and Tobramycin | Experimental | One-time dosage of topical vancomycin (1 gram) and tobramycin (1.2 grams) powder. Receives: Drug: Vancomycin and Tobramycin antibiotics. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent (%) positive deep tissue infections.
Percent (%) of positive deep tissue infections (number of infections/total participants X 100).
Measured: 6-months post-operative
Percent (%) negative deep tissue infections.
Percent (%) of negative deep tissue infections (number of infections/total participants X 100).
Measured: 6-months post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2023
- Study start27 Mar 2023
- Primary completion12 Dec 2024
- Study completion12 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfectionsStudies of the same condition, open and under way.
- More trials run by University of UtahThe 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Justin Haller, University of Utah
- Investigators
- Justin Haller, M.D., Principal investigator, University of Utah Orthopaedics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05849090
- Sponsor's protocol ID
- 158712
- Status last verified
- Dec 2024
- First submitted
- 11 Apr 2023
- Last updated
- 20 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 20 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot for Vancomycin and Tobramycin Powder Use in Acute Open Fractures in the Emergency Department
- ClinicalTrials.gov ID
- NCT05849090
- Acronym / sponsor ID
- 158712
- Conditions
- Infections
- Keywords
- Infections, Acute open fractures, Standard of care prophylactic antibiotics, Vancomycin and Tobramycin powder
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 27 Mar 2023 (actual)
- Primary completion
- 12 Dec 2024 (actual)
- Study completion
- 12 Dec 2024 (actual)
- First posted
- 8 May 2023 (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.
The investigators overall aim of this study is to determine the difference in 6-month infection rates in patients treated with the combined vancomycin and tobramycin (VT) powder compared to the standard of care (SC).
In order to evaluate this objective, the investigators propose the following specific aims for the pilot study:
Specific Aim 1: Assess VT and SC patient enrollment, randomization and early clinical follow-up. Hypothesis: This study will successfully enroll and randomize 50 patients, 25 into each treatment group and will achieve 85% clinical follow-up at 6-months post-ED admission date.
Open fracture patients/families that meet study inclusion/exclusion criteria will be approached by a study team member for informed consent. After providing consent, patients will be appropriately randomized to either VT or SC treatment. Patients will be clinically followed at regular intervals up to 6 months post-surgery. Enrollment, appropriate randomization and surgical allocation, and clinical follow-up will be evaluated.
Specific Aim 2: Compare infection rates, cultures and patient characteristics between groups. Hypothesis: VT will have a lower infection rate than the SC group. Additionally, randomization will create an equal distribution of patient demographics as well as fracture severity and soft tissue damage, as classified by the Gustilo-Anderson Classification System (GA).
Specific Aim 3: Compare local wound healing and fracture healing between VT group and SC group. Hypothesis: VT will have less rates of wound healing complications due to decreased infections. No local wound irritation or wound closure issues will be seen between groups. There will be no difference in fracture healing between groups.
Detailed description
Open limb fractures are severe orthopedic injuries and at an increased risk for complications including nonunion and infection. Rates of infection are dependent upon features such as extent of soft tissue trauma, patient characteristics, degree of contamination and modifiable factors such as time to surgical debridement and IV (intravenous) antibiotics. Surgical debridement within 24 hours and IV antibiotics are the current standard of care, but despite advances in care, the infection rates for these injuries has remained stable over the last several decades.
Possible explanations for this stagnation in care may be related to the current standard of care and the pathophysiology of open fractures. There is significant soft-tissue damage in open fractures, which compromises local vasculature leading to devascularized soft tissue and bone. This devitalized tissue serves as a nidus for infection, a base for biofilm production and reduces the level of systemic antibiotics delivered to the zone of injury. Local antibiotic therapy has the potential to overcome these challenges, by allowing a high concentration of antibiotics to be delivered to the devitalized tissue. Additional benefits of local antibiotics are their powdered form, which is stable, easy to transport, and can be applied immediately in austere situations without the need for IV access. A recent randomized control trial found a 4% decrease risk of infection following powdered vancomycin placement at the time of hardware fixation. However, a recent meta-analysis showed nearly a 12% risk reduction in open fractures treated with local antibiotics when compared to the standard of care. However, this meta-analysis was predominantly made up of small retrospective studies, underlying the need for a randomized control trial evaluating the efficacy of local antibiotics in acute open fracture management.
While causative organisms vary with location, cultures from open fractures are positive 83% of the time. Cultures have shown high rates of colonization of both gram-positive organisms (predominantly Staphylococcus aureus and epidermidis) as well as gram-negative organisms (mostly Pseudomonaonas aeruginosa). Given this prevalence the antibiotics vancomycin and tobramycin are likely good candidates given that they have high efficacy against the common colonizing bacteria, are available in standardize powdered formula, reach high local concentrations, and have a minimal cytotoxic effect to local cells6. Using a combination of vancomycin and tobramycin in the acute care of severe open fractures may substantially decrease risks of infection from both gram-positive and gram-negative pathogens.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of care prophylactic antibiotics | Active comparator | Drug: Cephalosporin or clindamycin/vancomycin antibiotics..Standard irrigation and IV, cephalosporin, 2-grams, intravenous (IV), * or standard irrigation and IV, clindamycin (900mg) / vancomycin (20mg/kg), intravenous (IV) for patients with cephalosporin allergies. |
| Vancomycin and Tobramycin | Experimental | Drug: Vancomycin and Tobramycin antibiotics.One-time dosage of topical vancomycin (1 gram) and tobramycin (1.2 grams) powder. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Open fracture GA class II or III, and one of the following fracture locations:
- Calcaneus fracture,
- Tibial plafond (pilon) fracture,
- Tibial plateau fracture,
- Tibial shaft fracture,
Key exclusion criteria (4 listed)
- Known allergy to vancomycin or tobramycin.
- Known kidney disease prior to admission, chronic Kidney Disease stage 4 -5.
- Any patients, family members, or staff who refuse to participate.
- Pregnant women, as identified through pregnancy test which is taken in the emergency department as standard of care.
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 |
|---|---|---|
| Cephalosporin or clindamycin/vancomycin antibiotics..Also: Cephalosporin - Cefazolin, (Ancef, Kefzol, Cefacidil), Cephalosporin- Ceftriaxone, (Ceftrisol Plus, Rocephin), Clindamycin, (Cleocin, Clindesse), Vancomycin, (Vancocin)Antibiotics: Cephalosporin, 2-grams, intravenous (IV), or clindamycin (900mg) / vancomycin (20mg/kg), intravenous (IV). | Drug | Standard of care prophylactic antibiotics |
| Vancomycin and Tobramycin antibiotics.Also: Vancomycin, (Vancocin), Tobramycin, (Tobi, Tobrex, Nebcin)Vancomycin (1 gram) and tobramycin (1.2 grams). | Drug | Vancomycin and Tobramycin |
Primary outcome
Percent (%) positive deep tissue infections.
Time frame: 6-months post-operative
Percent (%) of positive deep tissue infections (number of infections/total participants X 100).
Percent (%) negative deep tissue infections.
Time frame: 6-months post-operative
Percent (%) of negative deep tissue infections (number of infections/total participants X 100).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2024.
- 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.
Justin Haller, M.D. principal investigator
University of Utah Orthopaedics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Cephalosporin or clindamycin/vancomycin antibiotics.. and Vancomycin and Tobramycin antibiotics. in people with Infections, run by University of Utah 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 9 inclusion and 4 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 20 Dec 2024. 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. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Percent (%) positive deep tissue infections. (time frame: 6-months post-operative). The study lists 2 primary outcomes in all. 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 20 Dec 2024.