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

Lumbar Spinal Stenosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04341831
• Other study ID #: 70366045618
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: April 15, 2020
• Est. completion date: April 15, 2021

Study information

• Verified date: April 2020
• Source: Bezmialem Vakif University
• Contact: Murat Sarikas, MD
• Phone: 00905414346105
• Email: msarikas[@]bezmialem.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: April 15, 2021
• Est. primary completion date: January 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Infection
• Lumbar Disc Herniation
• Lumbar Disc Lesion
• Lumbar Spinal Stenosis
• Lumbar Spondylolisthesis
• Scoliosis
• Scoliosis Lumbar Region
• Spinal Stenosis
• Spondylolisthesis
• Surgical Wound Infection

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bezmialem Vakif University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Surgical site infection	Surgical site infection rates will be compared between two goups	90 days