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

April 10, 2020 updated by: Murat Sarikas, Bezmialem Vakif University

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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 Names:
  • Targocid
No Intervention: Group 2
We will not used any antibiotic powder in this group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Surgical site infection
Time Frame: 90 days
Surgical site infection rates will be compared between two goups
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bezmialem Vakif University

Investigators

  • Principal Investigator: Murat Sarıkaş, MD, Bezmialem Vakif University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 15, 2020

Primary Completion (Anticipated)

January 15, 2021

Study Completion (Anticipated)

April 15, 2021

Study Registration Dates

First Submitted

April 8, 2020

First Submitted That Met QC Criteria

April 9, 2020

First Posted (Actual)

April 10, 2020

Study Record Updates

Last Update Posted (Actual)

April 14, 2020

Last Update Submitted That Met QC Criteria

April 10, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 70366045618

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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