VancomycinPhase 2/3IV-DIRTNCT03221023
Intrawound Vancomycin Prophylaxis for Neural Stimulator
A Phase 2/3 study testing Vancomycin Hydrochloride and Saline Solution in people with Vancomycin and Implantable Neural Stimulator, run by University of British Columbia at 1 site in Canada.
Trial summary
The implantable pulse generator (IPG) is a device that generates electrical current to stimulate the spine, heart, or brain for various chronic conditions. In neurosurgery, the IPG is implanted in a subcutaneous pocket under the collarbone. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Vancomycin, Implantable Neural Stimulator, Deep Brain Stimulation
- What is being tested?
- Vancomycin Hydrochloride and Saline Solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 900 participants
- Where
- 1 siteCanada
- Study dates
- 15 Sep 2017to 15 Dec 2021
- Phase
- Phase 2/3
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- individuals who require INS replacement from Dr. C.R. Honey
- individuals who are between the ages of 18 to 80.
- individuals who consent to report any redness or swelling to their primary caregiver and follow-up as requested by their surgeon
- individuals who consent to keeping the study team informed of any medical concerns they may have regarding their INS for a minimum of 6 months postoperatively
- individuals who are capable of providing informed consent
Who cannot join
- individuals who have a history of autoimmune disease
- individuals who are undergoing any surgery or procedural intervention within six-months post-operatively of entrance into this study
- individuals who are on immunosuppression or any medication that would influence infection susceptibility
- individuals who are allergic to Vancomycin or Cefazolin
Trial locations and contacts
1 site in 1 country.
Leah Polyhronopoulos, BSc contact
Canada1 site, 1 recruiting
- Recruiting
Vancouver General Hospital
Vancouver, British Columbia, V5Z 1M9
About this study
Official title: Intrawound Vancomycin Prophylaxis During Stimulator Re-Implantation: A Multi-Center Randomized Controlled Trial
The implantable pulse generator (IPG) is a device that generates electrical current to stimulate the spine, heart, or brain for various chronic conditions. In neurosurgery, the IPG is implanted in a subcutaneous pocket under the collarbone. This pocket is highly avascular and thus, antibiotics administered intravenously cannot reach a potential surgical site infection (SSI). SSIs cause millions of health care dollars to be wasted due to repeat surgery and hospital re-admissions. The investigators hope to to determine the effects of "intrawound vancomycin-saline and IV antibiotics" compared to "saline and IV antibiotics" on the incidence of IPG SSI rates 6-months post-surgery.
Read the detailed description
Patients requiring neurosurgical IPG replacements will be recruited into this trial on a volunteer basis. The participants meeting the inclusion criteria will be randomized to either the treatment arm (intrawound Vancomycin-saline + IV antibiotics) or control arm (intrawound saline + IV antibiotics alone) by site in a 1:1 ratio. A sample size calculation using STplan determined that 405 patients per arm is required to reduce overall infection rate from 3.5% to 0.5% (80% power, α=0.05, two-tailed). Final sample size per arm will be 410 after generously accounting for loss to follow-up, non-compliance, and unrelated death.
The primary outcome will be a binary Yes/No on if IPG explantation due to infection was required within 6-months post-surgery.
This is a superiority trial and the investigators hypothesize intrawound Vancomycin-saline + IV antibiotics is superior to intrawound saline + IV antibiotics alone. An intention-to-treat analysis will be applied in a blinded manner once all patients have completed the trial and the database is locked.
The results of this trial will not only be applicable to neurosurgery, but also spine and cardiology.
- Conditions
- Vancomycin, Implantable Neural Stimulator, Deep Brain Stimulation, Surgical Site Infection
- Being tested
- Vancomycin Hydrochloride, Saline Solution
- Keywords
- Vancomycin, Implantable Neural Stimulator, Deep Brain Stimulation, Surgical Site Infection
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vancomycin HydrochlorideDrug
Individuals in the experimental arm will receive intrawound Vancomycin-saline + IV antibiotics
Saline SolutionDrug
Individuals in the control arm will receive intrawound saline solution
| Study group | Role | What they receive |
|---|---|---|
| Vancomycin | Experimental | These patients will receive intrawound Vancomycin-saline and IV antibiotics Receives: Drug: Vancomycin Hydrochloride; Drug: Saline Solution |
| Saline | Placebo comparator | These patients will receive intrawound saline + IV antibiotics alone Receives: Drug: Saline Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Device explantation 6 months post surgery
The primary outcome measure will be determined at the 6 month post surgery point, where the binary yes/no question, "was the INS device explanted", will be answered.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2017
- Study start15 Sep 2017
- Primary completion15 Sep 2021 (estimated)
- Study completion15 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for VancomycinStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The subjects meeting the inclusion criteria will be randomized to either the treatment arm or the control arm by site in a 1:1 ratio.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher Honey, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03221023
- Sponsor's protocol ID
- H16-01496
- Acronym
- IV-DIRT
- Status last verified
- Oct 2020
- First submitted
- 12 Jul 2017
- Last updated
- 30 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Doshi PK. Long-term surgical and hardware-related complications of deep brain stimulation. Stereotact Funct Neurosurg. 2011;89(2):89-95. doi: 10.1159/000323372. Epub 2011 Feb 2.
PubMed 21293168Caroom C, Tullar JM, Benton EG Jr, Jones JR, Chaput CD. Intrawound vancomycin powder reduces surgical site infections in posterior cervical fusion. Spine (Phila Pa 1976). 2013 Jun 15;38(14):1183-7. doi: 10.1097/BRS.0b013e31828fcfb5.
PubMed 23474597Martin JR, Adogwa O, Brown CR, Kuchibhatla M, Bagley CA, Lad SP, Gottfried ON. Experience with intrawound vancomycin powder for posterior cervical fusion surgery. J Neurosurg Spine. 2015 Jan;22(1):26-33. doi: 10.3171/2014.9.SPINE13826.
PubMed 25380539Ghobrial GM, Cadotte DW, Williams K Jr, Fehlings MG, Harrop JS. Complications from the use of intrawound vancomycin in lumbar spinal surgery: a systematic review. Neurosurg Focus. 2015 Oct;39(4):E11. doi: 10.3171/2015.7.FOCUS15258.
PubMed 26424335
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intrawound Vancomycin Prophylaxis During Stimulator Re-Implantation: A Multi-Center Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03221023
- Acronym / sponsor ID
- IV-DIRT / H16-01496
- Conditions
- Vancomycin, Implantable Neural Stimulator, Deep Brain Stimulation, Surgical Site Infection
- Keywords
- Vancomycin, Implantable Neural Stimulator, Deep Brain Stimulation, Surgical Site Infection
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- 15 Sep 2017 (actual)
- Primary completion
- 15 Sep 2021 (estimated)
- Study completion
- 15 Dec 2021 (estimated)
- First posted
- 18 Jul 2017 (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 implantable pulse generator (IPG) is a device that generates electrical current to stimulate the spine, heart, or brain for various chronic conditions. In neurosurgery, the IPG is implanted in a subcutaneous pocket under the collarbone. This pocket is highly avascular and thus, antibiotics administered intravenously cannot reach a potential surgical site infection (SSI). SSIs cause millions of health care dollars to be wasted due to repeat surgery and hospital re-admissions. The investigators hope to to determine the effects of "intrawound vancomycin-saline and IV antibiotics" compared to "saline and IV antibiotics" on the incidence of IPG SSI rates 6-months post-surgery.
Detailed description
Patients requiring neurosurgical IPG replacements will be recruited into this trial on a volunteer basis. The participants meeting the inclusion criteria will be randomized to either the treatment arm (intrawound Vancomycin-saline + IV antibiotics) or control arm (intrawound saline + IV antibiotics alone) by site in a 1:1 ratio. A sample size calculation using STplan determined that 405 patients per arm is required to reduce overall infection rate from 3.5% to 0.5% (80% power, α=0.05, two-tailed). Final sample size per arm will be 410 after generously accounting for loss to follow-up, non-compliance, and unrelated death.
The primary outcome will be a binary Yes/No on if IPG explantation due to infection was required within 6-months post-surgery.
This is a superiority trial and the investigators hypothesize intrawound Vancomycin-saline + IV antibiotics is superior to intrawound saline + IV antibiotics alone. An intention-to-treat analysis will be applied in a blinded manner once all patients have completed the trial and the database is locked.
The results of this trial will not only be applicable to neurosurgery, but also spine and cardiology.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- The subjects meeting the inclusion criteria will be randomized to either the treatment arm or the control arm by site in a 1:1 ratio.
| Arm | Type | Receives |
|---|---|---|
| Vancomycin | Experimental | Drug: Vancomycin Hydrochloride, Drug: Saline SolutionThese patients will receive intrawound Vancomycin-saline and IV antibiotics |
| Saline | Placebo comparator | Drug: Saline SolutionThese patients will receive intrawound saline + IV antibiotics alone |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- individuals who require INS replacement from Dr. C.R. Honey
- individuals who are between the ages of 18 to 80.
- individuals who consent to report any redness or swelling to their primary caregiver and follow-up as requested by their surgeon
- individuals who consent to keeping the study team informed of any medical concerns they may have regarding their INS for a minimum of 6 months postoperatively
- individuals who are capable of providing informed consent
Key exclusion criteria (4 listed)
- individuals who have a history of autoimmune disease
- individuals who are undergoing any surgery or procedural intervention within six-months post-operatively of entrance into this study
- individuals who are on immunosuppression or any medication that would influence infection susceptibility
- individuals who are allergic to Vancomycin or Cefazolin
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 |
|---|---|---|
| Vancomycin HydrochlorideIndividuals in the experimental arm will receive intrawound Vancomycin-saline + IV antibiotics | Drug | Vancomycin |
| Saline SolutionIndividuals in the control arm will receive intrawound saline solution | Drug | Saline, Vancomycin |
Primary outcome
Device explantation 6 months post surgery
Time frame: 6 months
The primary outcome measure will be determined at the 6 month post surgery point, where the binary yes/no question, "was the INS device explanted", will be answered.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2020.
- Background: PubMed 21293168Doshi PK. Long-term surgical and hardware-related complications of deep brain stimulation. Stereotact Funct Neurosurg. 2011;89(2):89-95. doi: 10.1159/000323372. Epub 2011 Feb 2.
- Background: PubMed 23474597Caroom C, Tullar JM, Benton EG Jr, Jones JR, Chaput CD. Intrawound vancomycin powder reduces surgical site infections in posterior cervical fusion. Spine (Phila Pa 1976). 2013 Jun 15;38(14):1183-7. doi: 10.1097/BRS.0b013e31828fcfb5.
- Background: PubMed 25380539Martin JR, Adogwa O, Brown CR, Kuchibhatla M, Bagley CA, Lad SP, Gottfried ON. Experience with intrawound vancomycin powder for posterior cervical fusion surgery. J Neurosurg Spine. 2015 Jan;22(1):26-33. doi: 10.3171/2014.9.SPINE13826.
- Background: PubMed 26424335Ghobrial GM, Cadotte DW, Williams K Jr, Fehlings MG, Harrop JS. Complications from the use of intrawound vancomycin in lumbar spinal surgery: a systematic review. Neurosurg Focus. 2015 Oct;39(4):E11. doi: 10.3171/2015.7.FOCUS15258.
- 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.
Leah Polyhronopoulos, BSc contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Vancomycin Hydrochloride and Saline Solution in people with Vancomycin and Implantable Neural Stimulator, run by University of British Columbia at 1 site in Canada.
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 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: status not confirmed, as of the sponsor's last update on 30 Oct 2020. 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 Canada. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christopher R Honey, MD, DPhil (6048755894, chris.honey@telus.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Device explantation 6 months post surgery (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03221023, which also lists 4 linked publications.
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 Oct 2020.