The Impact of Near-Infrared Vein Mapping on Outcomes and Satisfaction After Botox/Filler Treatment
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- Mayo Clinic
- 主要终点
- Patient satisfaction
研究概览
简要总结
Researchers are studying how vein mapping impacts patient outcomes and satisfaction after facial injection procedures.
详细描述
Facial Botox/filler injections carry risk of puncturing superficial veins, leading to bruising and pain. Our study will investigate the utility of non-invasive vein imaging (specifically near-infrared light reflection) on the incidence of pain/bruising/hematoma and patient satisfaction after facial injections.
The current standard of care for facial injection procedures does not involve any modality of facial venous mapping. Vein mapping is a non-invasive, simple task that takes very little time to conduct. One risk is patient time, however maximum extra time needed will be 5 minutes during the clinical visit. This potential extra time in mind, the benefits far outweigh the risks.
Two cohorts of patients will be prospectively compared following randomization, those who did have pre-procedure venous mapping prior to injection versus those who did not. Data will be analyzed with regard to bruising and swelling following injection, as well as other potential complications such as hematoma or infection, along with patient satisfaction survey information.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- 是
入选标准
- •Patients pursuing aesthetic/therapeutic facial injection procedures (botox/filler)
排除标准
- •Patients undergoing aesthetic facial procedures not requiring needle injection
研究组 & 干预措施
Control Goup
Subjects will undergo clinically indicated facial injection procedures per standard of care without venous mapping
Intervention Group
Subjects will undergo clinically indicated facial injection procedure with pre-procedural facial venous mapping by Accuvein® Veinfinder
干预措施: Accuvein® Veinfinder (Device)
结局指标
主要结局
Patient satisfaction
时间窗: Approximately 7-10 days following the procedure
Measured using the self-reported FACE-Q satisfaction score, using a scale of 1=definitely disagree and 4=definitely agree
次要结局
- Rate of Bruising/Hematoma(Approximately 7-10 days following the procedure)
研究者
William J. Casey, III
Principal Investigator
Mayo Clinic
