Lumbar PainNCT02299882
Surgical Infection Rates With Adjunct Vancomycin Compared to Standard Peri-Operative IV Antibiotics
A study testing Vancomycin in people with Lumbar Pain, run by Corewell Health West at 1 site in United States.
Trial summary
Determine the effect of Vancomycin Powder added to the surgical wound at closure on surgical infection rates. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lumbar Pain
- What is being tested?
- Vancomycin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 700 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to Jan 2016
- Phase
- Interventional
- 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
- All adult, 18 years or greater undergoing posterior approach spinal surgery
Who cannot join
- Prisoner, pregnant women, patient under the age of 18, those of diminished decision making capacity.
- patients with known reaction to Vancomycin.
- patients having surgery specifically for spine infection
- patients having ADCF or ALIF
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Spectrum Health Hospitals
Grand Rapids, Michigan, 49503
Nichole Rodrique, 616-258-3886, Nichole.Rodrique@spectrumhealth.org
Jason Squires, DO
About this study
Determine the effect of Vancomycin Powder added to the surgical wound at closure on surgical infection rates.
Read the detailed description
Study will be blinded and randomized 1:1 to either Vancomycin Powder at closure or no vancomycin powder at closure.
- Conditions
- Lumbar Pain
- Being tested
- Vancomycin
- Keywords
- Posterior spine surgery, infection, vancomycin, surgical wound infection
- Medical subject headings
- Low Back Pain, Infections, Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VancomycinDrug
Patient will be randomized to either vancomycin or no vancomycin. This treatment will take place prior to the closure of the incision from back surgery.
| Study group | Role | What they receive |
|---|---|---|
| Vancomycin | Experimental | Patient will receive Vancomycin powder to the incision just before skin closure Receives: Drug: Vancomycin |
| no vancomycin | No intervention | Patient will be randomized to either vancomycin powder or no vancomycin powder. This arm the patient will not have the powder placed in the incision before skin closure. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical wound infection rate, both deep and superficial infections
Measured: 12 weeks post surgery
Secondary outcomes (1)
Post-operative rate of MRSA infections.
Measured: 12 weeks post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2014 (estimated)
- Study startAug 2012
- Primary completionAug 2015 (estimated)
- Study completionJan 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar PainStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Corewell Health West
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jason A Squires, DO, Corewell Health West
- Investigators
- Jason Squires, DO, Principal investigator, Corewell Health West
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02299882
- Sponsor's protocol ID
- 2012-166
- Status last verified
- Feb 2013
- First submitted
- 20 Feb 2013
- Last updated
- 24 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Infection Rates With Adjunct Vancomycin Compared to Standard Peri-Operative IV Antibiotics
- ClinicalTrials.gov ID
- NCT02299882
- Acronym / sponsor ID
- 2012-166
- Conditions
- Lumbar Pain
- Keywords
- Posterior spine surgery, infection, vancomycin, surgical wound infection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Corewell Health WestUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Aug 2015 (estimated)
- Study completion
- Jan 2016 (estimated)
- First posted
- 24 Nov 2014 (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.
Determine the effect of Vancomycin Powder added to the surgical wound at closure on surgical infection rates.
Detailed description
Study will be blinded and randomized 1:1 to either Vancomycin Powder at closure or no vancomycin powder at closure.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vancomycin | Experimental | Drug: VancomycinPatient will receive Vancomycin powder to the incision just before skin closure |
| no vancomycin | No intervention | –Patient will be randomized to either vancomycin powder or no vancomycin powder. This arm the patient will not have the powder placed in the incision before skin closure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All adult, 18 years or greater undergoing posterior approach spinal surgery
Key exclusion criteria (4 listed)
- Prisoner, pregnant women, patient under the age of 18, those of diminished decision making capacity.
- patients with known reaction to Vancomycin.
- patients having surgery specifically for spine infection
- patients having ADCF or ALIF
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 |
|---|---|---|
| VancomycinPatient will be randomized to either vancomycin or no vancomycin. This treatment will take place prior to the closure of the incision from back surgery. | Drug | Vancomycin |
Primary outcome
Surgical wound infection rate, both deep and superficial infections
Time frame: 12 weeks post surgery
1 secondary outcome
Post-operative rate of MRSA infections.
Time frame: 12 weeks post surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2014.
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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.
Jason Squires, DO principal investigator
Corewell Health West
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vancomycin in people with Lumbar Pain, run by Corewell Health West 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 1 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 24 Nov 2014. 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.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical wound infection rate, both deep and superficial infections (time frame: 12 weeks post surgery). 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 24 Nov 2014.