Transillumination to Reduce Post-injection Complications in Aesthetic Medicine

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-01

Study Completion Date

2018-07-01

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.

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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.

Conditions

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E05.642.500

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

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.

Study Groups

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Transillumination Venolux®

Transillumination using Venolux was used to visualize veins in the hemiface before hyaluronic acid injections

Group Type EXPERIMENTAL

Transillumination Venolux®

Intervention Type DEVICE

Transillumination Venolux® method was used on the other half of the face before injections to visualize veins.

Comparator group

No vascular exploration methods were used on the other hemiface

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Transillumination Venolux®

Transillumination Venolux® method was used on the other half of the face before injections to visualize veins.

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes