Randomized Controlled Trial Comparing Irrisept Versus Normal Saline for Wound Irrigation After Posterior Spine Surgery
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Center for Disease Control (CDC)-defined 90-day surgical site infection incidence
研究概览
简要总结
To compare post-operative wound complications in patients randomized to normal saline versus Irrisept solution and any other adverse reactions from the solution.
详细描述
Wound complications represent a significant risk factor in spinal surgery, particularly in complex multilevel procedures. Surgical site infections (SSI) are the most common health care-associated infection, accounting for 31% of all hospitalized patients with a health care-associated infection. The reported incidence of SSIs following spine surgery ranges from 0.2% to 18.8%. In one study, each episode of wound infection following spine procedure contributed to a mean increase in the cost of care by $4,067 compared to a non-complicated case. The bacteria can adhere to the implants and tissues to create biofilm made by polysaccharide matrix which makes it challenging to clear the infection. Different irrigation techniques and solutions have been utilized to help limit post-operative wound complications. No studies have compared Irrisept solution to normal saline to see if there is a difference in wound complications for posterior spine surgeries.
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 (Participant)
盲法说明
Irrisept can be differentiated visually from normal saline. Patients will be informed in the consent that they will be blinded to the treatment they are randomized to throughout the study.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presenting to the University of Missouri hospital system - including the University of Missouri Hospital and Missouri Orthopaedic Institute - with a need for isolated open posterior spine procedures using a posterior open approach.
- •Failed conservative treatment - rest, anti-inflammatory medications, physical therapy
- •>18 years old and able to provide informed consent
排除标准
- •Ongoing or suspected infection
- •Revisions of failed back surgeries
- •Documented allergy to CHG or CHG products
- •Pregnancy - qualitative beta human chorionic gonadotropin (hCG) testing will be performed prior to enrollment
- •Prisoners or wards of the state
- •Unable to consent to research study
研究组 & 干预措施
Placebo Group
Patients in this group will be given the placebo (sterile saline).
干预措施: saline 0.9% (Drug)
Irrisept
Patients in this group will be given the study drug (Irrisept).
干预措施: (0.05% chlorhexidine gluconate (CHG) in sterile water) (Drug)
结局指标
主要结局
Center for Disease Control (CDC)-defined 90-day surgical site infection incidence
时间窗: 90 days after surgery
Comparing post-operative surgical site infection incidence between groups for 90 days post-operative using chi-square test.
次要结局
- Wound healing(90 days after surgery)
- Wound complications(90 days after surgery)
研究者
Don Moore, MD
PROF, AST CLINICAL DEPT
University of Missouri-Columbia