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临床试验/NCT04341831
NCT04341831Unknown3 期

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

Bezmialem Vakif University0 个研究点目标入组 120 人开始时间: 2020年4月15日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
入组人数
120
主要终点
Surgical site infection

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

研究组 & 干预措施

Group 1

Experimental

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

干预措施: Teicoplanin (Drug)

结局指标

主要结局

Surgical site infection

时间窗: 90 days

Surgical site infection rates will be compared between two goups

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Murat Sarikas

Orthopaedics surgeon

Bezmialem Vakif University

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