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Does Teicoplanin Powder Use In Lumbar Instrumentation Surgery Reduce Surgical Site Infection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04341831
Recruitment Status : Not yet recruiting
First Posted : April 10, 2020
Last Update Posted : April 14, 2020
Sponsor:
Information provided by (Responsible Party):
Murat Sarikas, Bezmialem Vakif University

Brief 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.

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

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
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

Arm Intervention/treatment
Experimental: Group 1
We will be added 200mg teicoplanin powder around instrument for each level.
Drug: Teicoplanin
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.



Primary Outcome Measures :
  1. Surgical site infection [ Time Frame: 90 days ]
    Surgical site infection rates will be compared between two goups



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Lumbar spinal stenosis,
  • LDH(Lumbar Disc Hernia)
  • Lumbar degenerative scoliosis
  • Lumbar spondylolisthesis

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

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


Contacts
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Contact: Murat Sarıkaş, MD 00905414346105 msarikas@bezmialem.edu.tr

Sponsors and Collaborators
Bezmialem Vakif University
Investigators
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Principal Investigator: Murat Sarıkaş, MD Bezmialem Vakif University
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Responsible Party: Murat Sarikas, Orthopaedics surgeon, Bezmialem Vakif University
ClinicalTrials.gov Identifier: NCT04341831    
Other Study ID Numbers: 70366045618
First Posted: April 10, 2020    Key Record Dates
Last Update Posted: April 14, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Murat Sarikas, Bezmialem Vakif University:
Spine Surgery
Teicoplanin powder
Surgical site infection
Posterior lumbar instrumentation
Additional relevant MeSH terms:
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Infection
Surgical Wound Infection
Scoliosis
Spinal Stenosis
Spondylolisthesis
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Wound Infection
Postoperative Complications
Pathologic Processes
Spondylolysis
Spondylosis
Teicoplanin
Anti-Bacterial Agents
Anti-Infective Agents