NCT04396613已完成不适用
Assessment of Wound Closure Techniques in Primary Spine Surgery Using SPY Intra-operative Angiography
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Lowest perfusion - 10 Adjacent
研究概览
简要总结
The Researchers are trying to determine if there is a difference in blood flow around a wound site when comparing three different types of wound closure techniques.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
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
- •≥ 18 years old
- •Primary diagnosis of spinal stenosis
- •Surgical indication for 1 or 2 level posterior spinal decompression or fusion
排除标准
- •Pregnant or Breastfeeding
- •Previous posterior spinal surgery
- •Systemic corticosteroid use
- •Long-term anticoagulation treatment
- •Diagnosis of diabetes mellitus
- •Diagnosis of peripheral arterial disease
- •Current smoker
- •Active infection of any kind or chronic infection with HIV, Hepatitis C, or Syphilis
- •Iodine Allergy
研究组 & 干预措施
Interrupted Vertical Mattress Suture
Active Comparator
干预措施: Closure technique (Procedure)
Running Subcuticular Suture
Active Comparator
干预措施: Closure technique (Procedure)
Staple Closure Techniques
Active Comparator
干预措施: Closure technique (Procedure)
结局指标
主要结局
Lowest perfusion - 10 Adjacent
时间窗: Baseline
Lowest perfusion score per 10 measurements taken along the wound closure as a percentage of perfusion at a standard location (5cm above incision).
次要结局
- Average perfusion - 10 Adjacent(At time of procedure)
- Lowest perfusion - 20 Sides(At time of procedure)
- Average perfusion - 20 Sides(At time of procedure)
- Lowest perfusion - 10 Alongside(At time of procedure)
- Lowest perfusion - 20 Adjacent(At time of procedure)
- Average perfusion - 10 Alongside(At time of procedure)
研究者
Arjun S. Sebastian
Principal Investigator
Mayo Clinic
研究点 (1)
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