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临床试验/NCT04240080
NCT04240080撤回不适用

The Impact of Near-Infrared Vein Mapping on Outcomes and Satisfaction After Botox/Filler Treatment

Mayo Clinic0 个研究点开始时间: 2020年1月10日最近更新:
适应症
干预措施

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

No Intervention

Subjects will undergo clinically indicated facial injection procedures per standard of care without venous mapping

Intervention Group

Experimental

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

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

William J. Casey, III

Principal Investigator

Mayo Clinic

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