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临床试验/NCT02490631
NCT02490631已完成3 期

A Randomized Controlled Trial of 2% Chlorhexidine Gluconate Skin Preparation Cloths for the Prevention of Post op Surgical Site Infections in Spine Patients (Decrease SSI or DeSSI)

Vanderbilt University1 个研究点 分布在 1 个国家目标入组 158 人开始时间: 2015年8月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
158
试验地点
1
主要终点
Participants With Surgical Site Infection Development at 30 Days Post-operative

研究概览

简要总结

Surgical site infection (SSI) following spinal surgery is a frequent complication and results in higher morbidity, mortality and healthcare costs. SSI following adult spinal surgery is a frequent complication that has been reported to occur in 0.7-12.0% of patients and result in higher postoperative morbidity, mortality and health care costs. Vanderbilt University Medical Center SSI rate is 7%. Treatment for SSI can be challenging often requiring revision surgery, long-term antibiotics, and prolonged hospitalization. The accurate identification of risk factors is thus important in the development of strategies to prevent these potentially devastating infections. This study proposes a randomized, controlled trial of neuro-spine patients of 2% chlorhexidine gluconate skin preparation cloths for the prevention of post op surgical site infections in spine patients.

Use of CHG cloths the night before and morning of surgery (neckline to toes) will affect (decrease rates) of SSI compared to patients who receive routine standard of care (soap and water pre-op, day of surgery and daily post-operative).

详细描述

Pre-operatively patients scheduled for neurosurgical spine cases will be evaluated and approached for interest, if consenting process completed, patients will be randomized to one of 2 arms in 1:1 through a block randomization table.

Those enrolled into the study arm will receive the CHG cloths and instructions for use from research personal. Those randomized to the control arm will receive standard of care skin cleansing by nursing staff.

All subjects who have signed consent will have a skin swab culture taken the day of screening and prior to cleansing with Chlorhexidine gluconate wipes close to the intended incision line. The investigators will also obtain skin swab cultures at site of incision preoperatively on the day of surgery, post-op day 4 or time of discharge and at the 30 day follow up.

Both groups will be evaluated daily by study personnel for the development of SSI until post-op day 4 or hospital discharge whichever one comes first. After dressing removal, a daily high definition picture will be taken of the incision line to further document signs of SSI development (pictures will not have any patient identifiable information). Additional evaluations will take place at the 30 day (+/- 7 days) post-op visit. Blinded evaluators utilizing the CDC guideline will grade the incision line for presence of SSI. Measured change in skin flora will be performed by comparing skin swab cultures of intervention group versus standard of care group and individual changes pre and post operatively.

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
Single (Outcomes Assessor)

入排标准

年龄范围
19 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients scheduled for a neuro-spine procedure and have 2 of the following risk factors:
  • Diabetic OR
  • BMI>30 OR
  • ASA>2 OR
  • pre-operatively hospitalized OR
  • >60 years old OR
  • chronic steroids/immunosuppressive medications OR
  • prior history of SSI

排除标准

  • Unable to consent
  • Non English speaking
  • Known allergy to any of the ingredients contained in SAGE chlorhexidine gluconate cloths
  • Current infection or history of spine infections
  • Patients with tumors or intradural spinal pathology.

研究组 & 干预措施

Intervention Arm

Experimental

2% chlorhexidine gluconate cloths the night before and morning of surgery

干预措施: 2% chlorhexidine gluconate cloths (Drug)

结局指标

主要结局

Participants With Surgical Site Infection Development at 30 Days Post-operative

时间窗: post op day 30

Evaluation daily using the CDC guidelines, daily measurements and deidentified photos

次要结局

  • Number of Participants With Positive or Abnormal Skin Cultures on Day of Surgery, Day of Discharge, 30 Days Post-op(Day of Surgery, Day of Discharge, 30 days post-op)

研究者

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

Elizabeth Card

Nursing Research Consultant

Vanderbilt University

研究点 (1)

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