Irrisept Spinal Fusion Pilot Study Protocol
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Postoperative surgical site infections
研究概览
简要总结
Study objectives include assessing the use of Irrisept irrigation solution in lumbar spinal fusion procedures and effect on clinical and patient reported outcome measures. This includes assessing postoperative SSI as well as fusion rates in addition to patient reported outcome measures.
详细描述
This is a randomized controlled pilot study with a study size of 50 patients. Results will be utilized to plan a larger scale study. Background literature supports the use of chlorhexidine gluconate as an irrigation solution to decrease SSI although this has not been conducted in this population of patients (lumbar spine fusion) to date. A decrease in SSI with Irrisept, could support the possible use of this as an irrigation solution to decrease infections postoperatively. It will be important to know the effect if any of Irrisept on fusion rates. This study will provide valuable information that may assist in future treatment and prevention of SSI in lumbar spinal fusion patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-85, undergoing primary lumbar spinal fusion (less than or equal to 3 levels)
排除标准
- •Prior lumbar fusion (decompression only okay), spinal infection, spinal neoplasm
研究组 & 干预措施
normal saline control arm
ii. normal saline used after initial skin incision prior to coming through fascia, after placement of instrumentation (screws, hooks), prior to placement of bone graft, and after fascial closure iii. Irrigation exposure/soak time to be 1 min for each irrigation time point.
干预措施: Irrisept Irrigation solution (Device)
Irrisept irrigation solution
ii. Irrigation (Irrisept vs control of normal saline) used after initial skin inicision prior to coming through fascia, after placement of instrumentation (screws, hooks), prior to placement of bone graft, and after fascial closure iii. Irrigation exposure/soak time to be 1 min for each irrigation time point. iv. 1 bottle (450 mL) Irrisept irrigation to be used during case with normal saline rinse to follow at each irrigation time point in study subjects
干预措施: Irrisept Irrigation solution (Device)
结局指标
主要结局
Postoperative surgical site infections
时间窗: assessed for change at 12 months
postop SSI
Postoperative surgical site infections
时间窗: assessed for change at 1 month
Postop SSI
Postoperative surgical site infections
时间窗: assessed for change at 3 months
postop SSI
Postoperative surgical site infections
时间窗: assessed for change at 6 months
postop SSI
次要结局
- Patient outcome measures(assessed at 12 months)
- Fusion rates after surgery(assessed for change at 12 months)
- Patient outcome measures(assessed at 1 month)
- Fusion rates after surgery(assessed at 1 month)
- Fusion rates after surgery(assessed for change at 3 months)
- Fusion rates after surgery(assessed for change at 6 months)
- Patient outcome measures(assessed at 3 months)
- Patient outcome measures(assessed at 6 months)