Transillumination to Reduce Post-injection Complications in Aesthetic Medicine

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Transillumination: A Non Invasive Method to Reduce Complications Associated With Facial Injections in Aesthetic Medicine.

Conditions
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E05.642.500

Intervention / Treatment
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* Device: Transillumination Venolux®


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients presenting for facial injections of hyaluronic acid Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The random assignment of the right or left side of the face on which the trasnillumination will be used will be done by numbered and sealed envelope. Envelopes will be prepared before the start of inclusion. Each envelope will contain a sheet of paper whose contents cannot be guessed when the envelope is closed. Each sheet will be marked either Left+TL or Right+TL. Each envelope will contain a unique code number that will be randomly assigned to each patient after inclusion.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Transillumination Venolux®<br>Transillumination using Venolux was used to visualize veins in the hemiface before hyaluronic acid injections | Device: Transillumination Venolux®<br>* Transillumination Venolux® method was used on the other half of the face before injections to visualize veins.<br>|
| No Intervention: Comparator group<br>No vascular exploration methods were used on the other hemiface | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of vessels detected by using transillumination | counting the number of vessels detected by using transillumination in relation to the number of existing vessels. | Before facial injections | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of bruises and hematoma | Number of bruises and heamatoma post-injection in in the hemiface where Transillumination is used versus control hemiface | At day 3 after facial injections | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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transillumination, Aesthetic injection, asthetic post-injection complications, hyaluronic acid, Facial injection