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

NCT04341831 | Unknown Phase 3

• 1 other identifier: 70366045618
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Lumbar Spinal Stenosis; Lumbar Disc Herniation; Scoliosis Lumbar Region; Lumbar Spondylolisthesis; Lumbar Disc Lesion

Keywords

Spine Surgery; Teicoplanin powder; Surgical site infection; Posterior lumbar instrumentation

Outcome Measures

Primary Outcomes (1)

• Surgical site infection

  Surgical site infection rates will be compared between two goups

  90 days

Study Arms (2)

Group 1

EXPERIMENTAL

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

Drug: Teicoplanin

Group 2

NO INTERVENTION

We will not used any antibiotic powder in this group.

Interventions

Teicoplanin DRUG

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.

Also known as: Targocid

Group 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bezmialem Vakif University: lead

MeSH Terms

Conditions

Spinal Stenosis; Intervertebral Disc Displacement; Spondylolisthesis; Surgical Wound Infection

Interventions

Teicoplanin

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Spondylolysis; Spondylosis; Wound Infection; Infections; Postoperative Complications; Pathologic Processes

Intervention Hierarchy (Ancestors)

Lipoglycopeptides; Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Murat Sarıkaş, MD

  Bezmialem Vakif University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Murat Sarıkaş, MD

CONTACT

00905414346105; msarikas@bezmialem.edu.tr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthopaedics surgeon

Study Record Dates

• First Submitted: April 8, 2020
• First Posted: April 10, 2020
• Study Start: April 15, 2020
• Primary Completion: January 15, 2021
• Study Completion: April 15, 2021
• Last Updated: April 14, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share