Transillumination to Reduce Post-injection Complications in Aesthetic Medicine

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

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.

Study Overview

• Status: Completed
• Conditions: E05.642.500
• Intervention / Treatment: Device: Transillumination Venolux®

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 Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Créteil, France, 94000
    • MEZI

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Transillumination Venolux®; Transillumination using Venolux was used to visualize veins in the hemiface before hyaluronic acid injections	Device: Transillumination Venolux®; Transillumination Venolux® method was used on the other half of the face before injections to visualize veins.
NO_INTERVENTION: Comparator group; No vascular exploration methods were used on the other hemiface

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Helynck, Patrick, M.D.
• Investigators: Principal Investigator: Jean Meningaud, MD.PhD, Department of plastic and reconstructive surgery-Henri Mondor Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2018
• Primary Completion (ACTUAL): June 1, 2018
• Study Completion (ACTUAL): July 1, 2018

Study Registration Dates

• First Submitted: February 8, 2021
• First Submitted That Met QC Criteria: February 8, 2021
• First Posted (ACTUAL): February 11, 2021

Study Record Updates

• Last Update Posted (ACTUAL): February 15, 2021
• Last Update Submitted That Met QC Criteria: February 10, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: hyaluronic acid; transillumination; Aesthetic injection; asthetic post-injection complications; Facial injection
• Other Study ID Numbers: 2017-A03325-48

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No