Transillumination to Reduce Post-injection Complications in Aesthetic Medicine

Not Applicable

Completed

• Conditions: E05.642.500
• Interventions: Device: Transillumination Venolux®

• Registration Number: NCT04750421
• Lead Sponsor: Helynck, Patrick, M.D.

Brief Summary

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

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.

Study Timeline

• Study Start: 2018-03-01
• Primary Completion: 2018-06-01
• Study Completion: 2018-07-01
• Status Verified: 2021-02
• Study First Submitted: 2021-02-08
• Study First Submitted QC: 2021-02-08
• Last Update Submitted: 2021-02-10
• Study First Posted: 2021-02-11
• Last Update Posted: 2021-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Transillumination Venolux®	Transillumination Venolux®	Transillumination using Venolux was used to visualize veins in the hemiface before hyaluronic acid injections

Primary Outcome Measures

Name	Time	Method
Number of vessels detected by using transillumination	Before facial injections	counting the number of vessels detected by using transillumination in relation to the number of existing vessels.

Secondary Outcome Measures

Name	Time	Method
Number of bruises and hematoma	At day 3 after facial injections	Number of bruises and heamatoma post-injection in in the hemiface where Transillumination is used versus control hemiface

Trial Locations

Locations (1)

MEZI; 🇫🇷 Créteil, France