Lumbar Spinal StenosisPhase 3NCT04341831
Does Teicoplanin Powder Use In Lumbar Instrumentation Surgery Reduce Surgical Site Infection
A Phase 3 study testing Teicoplanin in people with Lumbar Spinal Stenosis and Lumbar Disc Herniation, run by Bezmialem Vakif University.
Trial summary
Infection after spinal surgery is one of the serious complications. Spinal surgery infection can cause high morbidity, mortality, and costs. In spite of different prophylactic methods, up to 15% of infection appears after spinal surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lumbar Spinal Stenosis, Lumbar Disc Herniation, Scoliosis Lumbar Region
- What is being tested?
- Teicoplanin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 15 Apr 2020to 15 Apr 2021
- Phase
- Phase 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Lumbar spinal stenosis,
- LDH(Lumbar Disc Hernia)
- Lumbar degenerative scoliosis
- Lumbar spondylolisthesis
Who cannot join
- History of malignancy
- Systemic inflammatory disease
- Severe cardiac insufficiency
- Morbid obesity (>40 kg/m2 or 35 or more and experiencing obesity-related health conditions)
- History of lumbar spine surgery
Trial locations and contacts
No sites are listed yet.
About this study
Infection after spinal surgery is one of the serious complications. Spinal surgery infection can cause high morbidity, mortality, and costs. In spite of different prophylactic methods, up to 15% of infection appears after spinal surgery.
Vancomycin powder, which is one of the most applied methods, seems to be effective and inexpensive. However, vancomycin administration may be inconvenient in elderly participants with high comorbidity and especially kidney problems.
The investigators aimed to reduce the rate of infection in the post-op 90-day period by adding per-op Teicoplanin powder onto the implant in participants scheduled for lumbar posterior instrumentation.
Read the detailed description
Study Design:
The investigators will start trial after our institution's Clinical Research Ethics Committee approval. The protocol conforms to CONSORT guidelines for parallel-group randomized trials and the protocol is designed to conform to the principles of the Declaration of Helsinki.
Participant :
A literature review revealed that the surgical site infection rates after posterior instrumentation to be around 13-15%. Being a non-inferiority trial, the investigators hypothesized that the 90-day surgical site infection rates after posterior lumbar instrumentation should not be more than 1%. In order to find the difference of 14.0% between the two groups statistically significant, the minimum number of subjects required in each group was determined to be 55. (Power of 80 % and significance level at 0.05). To account for missing data, the drop-out rate was set to 10% and therefore, a total of 60 participants will be randomized.
The investigators will be included participants with spinal stenosis, LDH(Lumbar Disc Hernia), degenerative scoliosis or spondylolisthesis who did not respond to conservative treatment and participants in whom operation will be planned in the only lumbar spine. The investigators will be excluded participants with a history of malignancy, systemic inflammatory disease, severe cardiac insufficiency, morbid obesity (>40 kg/m2 or 35 or more and experiencing obesity-related health conditions) and participants who had undergone spine surgery previously. An informed consent form will be obtained from all participants.
The schedule for randomization will be randomly generated using a computer before the initiation of the trial. Participants will randomly be assigned in a 1:1 ratio. The investigators planned our study as double-blinded. Neither participants nor assessors will know about randomization results. The outcome assessor will be blinded to group allocation and won't be involved in providing the interventions. The statistician performing the statistical analyses will be blinded to group allocation.
Surgical procedures:
All surgeries will be performed by one surgeon under general anesthesia. The investigators will be used rod and pedicle screws of the same brand in all participants (Tasarım Med, Turkey)- using a standard posterior midline approach. All participants will be given 2 g cefazolin for infection prophylaxis and 1 g tranexamic acid for blood loss prophylaxis intravenously 30 min before the incision. In group 1 Teicoplanin powder will be placed on the rod and pedicle screws. The investigators will be added 200mg. teicoplanin powder around the instrument for each level. Hemovac drains will be used in either group. The drains will remain closed for 6 hours post-operatively for teicoplanin powder penetration in a surgical site.
All participants will be undergoing the same post-op rehabilitation protocol.
- Conditions
- Lumbar Spinal Stenosis, Lumbar Disc Herniation, Scoliosis Lumbar Region, Lumbar Spondylolisthesis, Lumbar Disc Lesion
- Being tested
- Teicoplanin
- Keywords
- Spine Surgery, Teicoplanin powder, Surgical site infection, Posterior lumbar instrumentation
- Medical subject headings
- Spinal Stenosis, Intervertebral Disc Displacement, Spondylolisthesis, Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TeicoplaninDrug
Also called Targocid
We will be used 200mg Teicoplanin powder for each level of instrument.Hemovac drains will be used in either group. The drains will remain closed for 6 hours post-operatively for teicoplanin powder penetration in a surgical site.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | We will be added 200mg teicoplanin powder around instrument for each level. Receives: Drug: Teicoplanin |
| Group 2 | No intervention | We will not used any antibiotic powder in this group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical site infection
Surgical site infection rates will be compared between two goups
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2020
- Study start15 Apr 2020 (estimated)
- Primary completion15 Jan 2021 (estimated)
- Study completion15 Apr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Spinal StenosisStudies of the same condition, open and under way.
- More trials run by Bezmialem Vakif UniversityThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Murat Sarikas, Bezmialem Vakif University
- Investigators
- Murat Sarıkaş, MD, Principal investigator, Bezmialem Vakif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04341831
- Sponsor's protocol ID
- 70366045618
- Status last verified
- Apr 2020
- First submitted
- 8 Apr 2020
- Last updated
- 14 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Teicoplanin Powder Use In Lumbar Instrumentation Surgery Reduce Surgical Site Infection
- ClinicalTrials.gov ID
- NCT04341831
- Acronym / sponsor ID
- 70366045618
- Conditions
- Lumbar Spinal Stenosis, Lumbar Disc Herniation, Scoliosis Lumbar Region, Lumbar Spondylolisthesis, Lumbar Disc Lesion
- Keywords
- Spine Surgery, Teicoplanin powder, Surgical site infection, Posterior lumbar instrumentation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 15 Apr 2020 (estimated)
- Primary completion
- 15 Jan 2021 (estimated)
- Study completion
- 15 Apr 2021 (estimated)
- First posted
- 10 Apr 2020 (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.
Infection after spinal surgery is one of the serious complications. Spinal surgery infection can cause high morbidity, mortality, and costs. In spite of different prophylactic methods, up to 15% of infection appears after spinal surgery.
Vancomycin powder, which is one of the most applied methods, seems to be effective and inexpensive. However, vancomycin administration may be inconvenient in elderly participants with high comorbidity and especially kidney problems.
The investigators aimed to reduce the rate of infection in the post-op 90-day period by adding per-op Teicoplanin powder onto the implant in participants scheduled for lumbar posterior instrumentation.
Detailed description
Study Design:
The investigators will start trial after our institution's Clinical Research Ethics Committee approval. The protocol conforms to CONSORT guidelines for parallel-group randomized trials and the protocol is designed to conform to the principles of the Declaration of Helsinki.
Participant :
A literature review revealed that the surgical site infection rates after posterior instrumentation to be around 13-15%. Being a non-inferiority trial, the investigators hypothesized that the 90-day surgical site infection rates after posterior lumbar instrumentation should not be more than 1%. In order to find the difference of 14.0% between the two groups statistically significant, the minimum number of subjects required in each group was determined to be 55. (Power of 80 % and significance level at 0.05). To account for missing data, the drop-out rate was set to 10% and therefore, a total of 60 participants will be randomized.
The investigators will be included participants with spinal stenosis, LDH(Lumbar Disc Hernia), degenerative scoliosis or spondylolisthesis who did not respond to conservative treatment and participants in whom operation will be planned in the only lumbar spine. The investigators will be excluded participants with a history of malignancy, systemic inflammatory disease, severe cardiac insufficiency, morbid obesity (>40 kg/m2 or 35 or more and experiencing obesity-related health conditions) and participants who had undergone spine surgery previously. An informed consent form will be obtained from all participants.
The schedule for randomization will be randomly generated using a computer before the initiation of the trial. Participants will randomly be assigned in a 1:1 ratio. The investigators planned our study as double-blinded. Neither participants nor assessors will know about randomization results. The outcome assessor will be blinded to group allocation and won't be involved in providing the interventions. The statistician performing the statistical analyses will be blinded to group allocation.
Surgical procedures:
All surgeries will be performed by one surgeon under general anesthesia. The investigators will be used rod and pedicle screws of the same brand in all participants (Tasarım Med, Turkey)- using a standard posterior midline approach. All participants will be given 2 g cefazolin for infection prophylaxis and 1 g tranexamic acid for blood loss prophylaxis intravenously 30 min before the incision. In group 1 Teicoplanin powder will be placed on the rod and pedicle screws. The investigators will be added 200mg. teicoplanin powder around the instrument for each level. Hemovac drains will be used in either group. The drains will remain closed for 6 hours post-operatively for teicoplanin powder penetration in a surgical site.
All participants will be undergoing the same post-op rehabilitation protocol.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: TeicoplaninWe will be added 200mg teicoplanin powder around instrument for each level. |
| Group 2 | No intervention | –We will not used any antibiotic powder in this group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Lumbar spinal stenosis,
- LDH(Lumbar Disc Hernia)
- Lumbar degenerative scoliosis
- Lumbar spondylolisthesis
Key exclusion criteria (5 listed)
- History of malignancy
- Systemic inflammatory disease
- Severe cardiac insufficiency
- Morbid obesity (>40 kg/m2 or 35 or more and experiencing obesity-related health conditions)
- History of lumbar spine surgery
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 |
|---|---|---|
| TeicoplaninAlso: TargocidWe will be used 200mg Teicoplanin powder for each level of instrument.Hemovac drains will be used in either group. The drains will remain closed for 6 hours post-operatively for teicoplanin powder penetration in a surgical site. | Drug | Group 1 |
Primary outcome
Surgical site infection
Time frame: 90 days
Surgical site infection rates will be compared between two goups
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2020.
- 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.
Murat Sarıkaş, MD principal investigator
Bezmialem Vakif University
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Teicoplanin in people with Lumbar Spinal Stenosis and Lumbar Disc Herniation, run by Bezmialem Vakif University.
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 4 inclusion and 5 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 14 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
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 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 Murat Sarıkaş, MD (00905414346105, msarikas@bezmialem.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical site infection (time frame: 90 days). 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 14 Apr 2020.