Fractures, OpenPhase 4NCT02400112
Local Application of Vancomycin Powder in Grade I-IIIA Open Fractures
A Phase 4 study testing Vancomycin in people with Fractures, Open and Surgical Wound Infection, run by University of Tennessee at 1 site in United States.
Trial summary
The purpose of this study is to determine if local administration of vancomycin powder at the site of Grade I-IIIA open fractures at the time of surgery will be an efficacious method to lower infection rates in open fracture treatment and to elucidate any detrimental effects of applying vancomycin powder at the site… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fractures, Open, Surgical Wound Infection
- What is being tested?
- Vancomycin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2015to Oct 2018
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Skeletally mature patients ≥18 years of age
- Acute Gustilo-Anderson Type I-IIIA open fracture
- Fracture is deemed primarily closable at initial surgery
- Likely to follow-up with surgeon until fracture is healed
- Ability to understand and agree to Informed Consent
Who cannot join
- Patients <18 years of age
- Gustilo-Anderson Type IIIB and IIIC open fractures
- Open fractures requiring multiple operations (i.e. for repeat surgical debridement or staged bone grafting of critical segmental defects)
- Delayed presentation of open fracture
- Pre-existing systemic infection requiring antibiotic therapy
- Allergy to Vancomycin
Show all 10Show fewer
- Open fracture at the site of a previous fracture or surgical site
- Current skin infection, chronic wounds or known systemic infection
- Unlikely to follow-up until fracture is healed
- Unable to understand or agree to Informed Consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Erlanger Health System
Chattanooga, Tennessee, 37403
About this study
The purpose of this study is to determine if local administration of vancomycin powder at the site of Grade I-IIIA open fractures at the time of surgery will be an efficacious method to lower infection rates in open fracture treatment and to elucidate any detrimental effects of applying vancomycin powder at the site of open fractures.
Read the detailed description
Hypothesis:
Local administration of 1 gram of vancomycin powder at the site of primarily closeable Gustilo-Anderson Grade I-IIIA open fractures at the time of surgery, in addition to clinically accepted open fracture management (intravenous antibiotics, surgical irrigation and debridement and stabilization), will significantly decrease the postoperative infection rate in comparison to the current treatment algorithm.
Methods:
Study subjects will be randomized to one of two groups prior to surgery (parallel group design): standard treatment (control group) versus vancomycin powder treatment (experimental group). Each group will have an equal number of subjects. Once randomized, the intervention is then un-blinded to facilitate treatment.
Post-operatively, all patients will receive intravenous antibiotics, such that all patients receive a total of 24 hours of intravenous antibiotics. The surgical drain will be removed at the patient's bedside approximately 24 hours after the surgical procedure. Patients will follow up with their surgeon for routine scheduled visits at approximately 2 weeks, 6 weeks, 12 weeks, and further until aseptic union or resolution of infection. There will be no additional appointments solely for the purpose of research follow-up.
- Conditions
- Fractures, Open, Surgical Wound Infection
- Being tested
- Vancomycin
- Keywords
- Vancomycin
- Medical subject headings
- Fractures, Open, Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VancomycinDrug
Vancomycin powder administered locally, intraoperatively at site of open fracture
| Study group | Role | What they receive |
|---|---|---|
| Vancomycin Powder | Experimental | If the patient randomizes to the experimental group (vancomycin powder), the patient will receive open fracture care identical to the control group except that, prior to closure, 1 gram of vancomycin powder will be applied locally to the open fracture bed. The traumatic and surgical wounds will be closed over a sterile drain and dressed, and the extremity will be immobilized. Receives: Drug: Vancomycin |
| Standard Treatment | No intervention | If the patient randomizes to the control group (standard treatment), the patient will receive irrigation and debridement of the fracture site and surrounding soft tissues. The fracture will then be stabilized in standard fashion determined by fracture personality. Once stabilized, a sterile drain will be placed in the open fracture bed and the traumatic and surgical wounds will be closed and dressed. The extremity will then be immobilized. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Infection
Infections will be considered clinically significant if they require a return to the operating suite for surgical debridement. These infections will be classified as acute infections and/or chronic osteomyelitis. Superficial skin infections will be treated with local wound care, oral antibiotics and incision and drainage (as indicated). Deep infections and chronic osteomyelitis will be treated with staged serial surgical debridement, hardware removal (as indicated), culture specific IV antibiotics, and Infectious Disease consultation.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionOct 2018
- Study completionOct 2018
Why it stopped: Low enrollment; Low clinical relevance: evidence for use of vancomycin powder
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fractures, OpenStudies of the same condition, open and under way.
- 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
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Tennessee
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dirk W Kiner, MD, Principal investigator, University of Tennessee College of Medicine Chattanooga/Erlanger Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02400112
- Sponsor's protocol ID
- 13-111
- Status last verified
- Nov 2018
- First submitted
- 23 Mar 2015
- Last updated
- 29 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Local Application of Vancomycin Powder in Grade I-IIIA Open Fractures
- ClinicalTrials.gov ID
- NCT02400112
- Acronym / sponsor ID
- 13-111
- Conditions
- Fractures, Open, Surgical Wound Infection
- Keywords
- Vancomycin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low enrollment; Low clinical relevance: evidence for use of vancomycin powder
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of TennesseeUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Oct 2018 (actual)
- Study completion
- Oct 2018 (actual)
- First posted
- 26 Mar 2015 (estimated)
- 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 purpose of this study is to determine if local administration of vancomycin powder at the site of Grade I-IIIA open fractures at the time of surgery will be an efficacious method to lower infection rates in open fracture treatment and to elucidate any detrimental effects of applying vancomycin powder at the site of open fractures.
Detailed description
Hypothesis:
Local administration of 1 gram of vancomycin powder at the site of primarily closeable Gustilo-Anderson Grade I-IIIA open fractures at the time of surgery, in addition to clinically accepted open fracture management (intravenous antibiotics, surgical irrigation and debridement and stabilization), will significantly decrease the postoperative infection rate in comparison to the current treatment algorithm.
Methods:
Study subjects will be randomized to one of two groups prior to surgery (parallel group design): standard treatment (control group) versus vancomycin powder treatment (experimental group). Each group will have an equal number of subjects. Once randomized, the intervention is then un-blinded to facilitate treatment.
Post-operatively, all patients will receive intravenous antibiotics, such that all patients receive a total of 24 hours of intravenous antibiotics. The surgical drain will be removed at the patient's bedside approximately 24 hours after the surgical procedure. Patients will follow up with their surgeon for routine scheduled visits at approximately 2 weeks, 6 weeks, 12 weeks, and further until aseptic union or resolution of infection. There will be no additional appointments solely for the purpose of research follow-up.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vancomycin Powder | Experimental | Drug: VancomycinIf the patient randomizes to the experimental group (vancomycin powder), the patient will receive open fracture care identical to the control group except that, prior to closure, 1 gram of vancomycin powder will be applied locally to the open fracture bed. The traumatic and surgical wounds will be closed over a sterile drain and dressed, and the extremity will be immobilized. |
| Standard Treatment | No intervention | –If the patient randomizes to the control group (standard treatment), the patient will receive irrigation and debridement of the fracture site and surrounding soft tissues. The fracture will then be stabilized in standard fashion determined by fracture personality. Once stabilized, a sterile drain will be placed in the open fracture bed and the traumatic and surgical wounds will be closed and dressed. The extremity will then be immobilized. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Skeletally mature patients ≥18 years of age
- Acute Gustilo-Anderson Type I-IIIA open fracture
- Fracture is deemed primarily closable at initial surgery
- Likely to follow-up with surgeon until fracture is healed
- Ability to understand and agree to Informed Consent
Key exclusion criteria (10 listed)
- Patients <18 years of age
- Gustilo-Anderson Type IIIB and IIIC open fractures
- Open fractures requiring multiple operations (i.e. for repeat surgical debridement or staged bone grafting of critical segmental defects)
- Delayed presentation of open fracture
- Pre-existing systemic infection requiring antibiotic therapy
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 |
|---|---|---|
| VancomycinVancomycin powder administered locally, intraoperatively at site of open fracture | Drug | Vancomycin Powder |
Primary outcome
Postoperative Infection
Time frame: one year
Infections will be considered clinically significant if they require a return to the operating suite for surgical debridement. These infections will be classified as acute infections and/or chronic osteomyelitis. Superficial skin infections will be treated with local wound care, oral antibiotics and incision and drainage (as indicated). Deep infections and chronic osteomyelitis will be treated with staged serial surgical debridement, hardware removal (as indicated), culture specific IV antibiotics, and Infectious Disease consultation.
Results and safety
The study was stopped early (reason given: Low enrollment; Low clinical relevance: evidence for use of vancomycin powder). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2018.
- 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.
Dirk W Kiner, MD principal investigator
University of Tennessee College of Medicine Chattanooga/Erlanger Health System
1 site 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 Fractures, Open and Surgical Wound Infection, run by University of Tennessee 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 10 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 29 Nov 2018. 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?
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?
The study was stopped early (reason given: Low enrollment; Low clinical relevance: evidence for use of vancomycin powder). Results are not available in the source record.
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?
Postoperative Infection (time frame: one year). 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 29 Nov 2018.