Does Teicoplanin Powder Use In Lumbar Instrumentation Surgery Reduce Surgical Site Infection
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|ClinicalTrials.gov Identifier: NCT04341831|
Recruitment Status : Not yet recruiting
First Posted : April 10, 2020
Last Update Posted : April 14, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Lumbar Spinal Stenosis Lumbar Disc Herniation Scoliosis Lumbar Region Lumbar Spondylolisthesis Lumbar Disc Lesion||Drug: Teicoplanin||Phase 3|
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.
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.
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Does Teicoplanin Powder Use In Lumbar Instrumentation Surgery Reduce Surgical Site Infection|
|Estimated Study Start Date :||April 15, 2020|
|Estimated Primary Completion Date :||January 15, 2021|
|Estimated Study Completion Date :||April 15, 2021|
Experimental: Group 1
We will be added 200mg teicoplanin powder around instrument for each level.
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.
Other Name: Targocid
No Intervention: Group 2
We will not used any antibiotic powder in this group.
- Surgical site infection [ Time Frame: 90 days ]Surgical site infection rates will be compared between two goups
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04341831
|Contact: Murat Sarıkaş, MDemail@example.com|
|Principal Investigator:||Murat Sarıkaş, MD||Bezmialem Vakif University|