Use of Dermabond in Mitigation of Spinal Cord Stimulation Trial Lead Migration
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 2
- 主要终点
- Migration rate of trial leads
研究概览
简要总结
During the typical SCS trial the leads remain outside of the skin and can be prone to migration. The leads are typically secured in place with suture, tape, or a combination of both. This study will evaluate the amount of movement based on the method of being secured at the time of placement
详细描述
Spinal Cord stimulator trials require precise placement of leads to get appropriate distribution of pain. Since the leads are not anchored into the tissue, migration of the leads can occur and result in suboptimal trial. Migration (or movement in the epidural space after placement) of the leads can result in up to 2.49 mm to 3.24 mm migration in the leads depending on trial length. During the trial the leads remain outside of the skin and can be prone to migration. The leads are typically secured in place with suture, tape, or a combination of both. This study will evaluate the amount of movement based on the method of being secured at the time of placement
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age greater than 18
- •having a spinal cord stimulator trial lead placement done
- •lead placement to be done in the thoracic spine area
排除标准
- •dermabond allergy
- •inability to place 2 leads in subject
- •lead placement not in thoracic spine
研究组 & 干预措施
Suture Group
secure one of the 2 trial leads with suture only-randomized to left or right
干预措施: Suture (Device)
结局指标
主要结局
Migration rate of trial leads
时间窗: From Baseline through Day 8
Migration rate of trial leads anchored with Dermabond and suture versus suture alone will be measured by change in trial lead position as measured in millimeters when comparing initial x-ray after placement versus x-ray taken at lead removal 5-8 days after placement
次要结局
- Difference in Lead Position - Prone Fluoroscopy vs Upright X-ray(Day 8)
- Number of Patients with Pain Relief(Day 8)
- Patient Satisfaction Score(Day 8)
- Rate of Infection(Day 8)