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

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

Sponsors

Lead Sponsor: Bezmialem Vakif University

Source 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.

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.

Overall Status Not yet recruiting
Start Date April 15, 2020
Completion Date April 15, 2021
Primary Completion Date January 15, 2021
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Surgical site infection 90 days
Enrollment 120
Condition
Intervention

Intervention Type: Drug

Intervention Name: Teicoplanin

Description: 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.

Arm Group Label: Group 1

Other Name: Targocid

Eligibility

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Murat Sarıkaş, MD Principal Investigator Bezmialem Vakif University
Overall Contact

Last Name: Murat Sarıkaş, MD

Phone: 00905414346105

Email: [email protected]

Verification Date

April 2020

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Bezmialem Vakif University

Investigator Full Name: Murat Sarikas

Investigator Title: Orthopaedics surgeon

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Group 1

Type: Experimental

Description: We will be added 200mg teicoplanin powder around instrument for each level.

Label: Group 2

Type: No Intervention

Description: We will not used any antibiotic powder in this group.

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Prevention

Masking: Double (Participant, Outcomes Assessor)

Source: ClinicalTrials.gov