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临床试验/NCT02767427
NCT02767427已完成不适用

The Value of Home Chlorhexidine Pre-Surgical Wash Before Spine Surgery

Columbia University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2016年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
1
主要终点
Number of Patients With Cutaneous Bacterial Load After Surgery

研究概览

简要总结

The study team hypothesizes that at-home cleansing of the surgical site with chlorhexidine wipes provide no added benefit to decreasing microbial activity or preventing surgical site infections.

Patients will be randomized to the chlorhexidine or no additional intervention groups. Patients will be randomized to use 4% chlorhexidine cloths, while the other half receive no additional intervention. Those randomized into the chlorhexidine gluconate (CHG) home-application group will be asked to shower the night before surgery, and to use a standardized pre-packaged CHG wipe (that the patients would receive at their pre-surgical consultation) on their surgical site after thoroughly drying those areas. The patients will be asked to use a second wipe in each area the morning of surgery. The surgical sites will be analyzed in two groups: anterior cervical and posterior spine. Each of these two groups will be randomized separately. All patients will undergo a standardized preoperative cleansing regimen. Once positioned, they will be cleansed with an alcohol solution. Then, the surgical site (either the anterior portion of the neck or the posterior area of the spine) will be scrubbed with chlorhexidine soaked brushes and then painted with chlorhexidine solution. Perioperative antibiotics will be given per attending surgeon preference. Cutaneous samples will be taken from the surgical site of each patient at each time point.

详细描述

To the investigator's knowledge no prior study has evaluated the effects of cleaning the skin at home before surgery in patients undergoing spine surgery. This study will investigate whether patients who use a chlorhexidine cleansing wipe have decreased amounts of bacteria on their skin when they arrive for scheduled spine surgery. Spine surgeons strive to decrease infections in their patients, so it is important to see if this intervention helps to do this.

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 (Care Provider, Investigator)

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

  • 18 years old or older
  • Scheduled for elective spine surgery at Columbia University Medical Center

排除标准

  • Unable to apply at-home chlorhexidine wipe by themselves
  • Deemed "high risk" preoperatively by the treating surgeon
  • Diagnosed with spine trauma
  • Undergoing deformity correction surgery
  • Unable to consent to the terms of the surgery
  • Known infection at time of the index procedure
  • Hospitalized within 1 week pre-operatively
  • Allergic to chlorhexidine
  • Immunocompromised
  • End stage renal disease on dialysis
  • Local or systemic skin disease (such as psoriasis, eczema, etc.)
  • Open skin wounds

结局指标

主要结局

Number of Patients With Cutaneous Bacterial Load After Surgery

时间窗: Pre-Surgery and Post Surgery, up to 4 hours

All specimens were taken by a sterile BD E-Swab. All samples will be sent immediately after acquisition to the microbiology lab for analysis within four hours.

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

Kiehyun Riew

Professor of Orthopedic Surgery at the Columbia University Medical Center

Columbia University

研究点 (1)

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