Transillumination: A Non Invasive Method to Reduce Complications Associated With Facial Injections in Aesthetic Medicine.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Number of vessels detected by using transillumination
研究概览
简要总结
Transillumination (TL) is a noninvasive technique that appears to allow preliminary detection of superficial vascular structures of the face to avoid intravascular HA injection. The purpose of our study was to test the efficacy of TL in terms of its sensitivity to locate vessels in the areas undergoing treatment and to reduce post-injection vascular complications.
详细描述
Transillumination was used during the injection of hyaluronic acid to reduce the risk of intravascular injection. For the purpose of randomization, patients were asked to choose a sealed envelope. Inside the envelope was a piece of paper indicating on which side of the face (right or left) the transillumination would be used.
For each filler injection, transillumination was used on one side; on the other side of the face, the injection was administered without the use of any vascular exploration method. After the vessels had been located on the side chosen for the transillumination technique, a skin-marker pencil was used to draw the vascular mapping of the upper part of the face, which in our opinion represented the area most at risk of complications, the middle and the lower parts of the face.
Then ice was applied on both sides of the face for 15 s before to proceed with the injections in order to cause vasoconstriction and to further decrease the risk of an intravascular injection.Transillumination sensitivity for locating the vessels of the face was assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
The operator will guarantee the confidentiality of the part of facial where the trasillumination was used, the assessors will not be aware of the part of the face where the transillumination was used.
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 presenting for facial injections of hyaluronic acid
排除标准
- •Patients with a history of allergy to a component of hyaluronic acid
- •Patients with arteritis (Horton)
- •Patients who have had previous facial surgery
- •pregnant or nursing patients
结局指标
主要结局
Number of vessels detected by using transillumination
时间窗: Before facial injections
counting the number of vessels detected by using transillumination in relation to the number of existing vessels.
次要结局
- Number of bruises and hematoma(At day 3 after facial injections)