Clinical trial NCT04750421: Transillumination to Reduce Post-injection Complications in Aesthetic Medicine
Official title: Transillumination: A Non Invasive Method to Reduce Complications Associated With Facial Injections in Aesthetic Medicine.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: E05.642.500
Keywords: transillumination
Aesthetic injection
asthetic post-injection complications
hyaluronic acid
Facial injection
Lead sponsor: Helynck, Patrick, M.D.
Sponsor class: OTHER
First posted: 2021-02-11
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of vessels detected by using transillumination
timeFrame: Before facial injections
Secondary outcomes:
measure: Number of bruises and hematoma
timeFrame: At day 3 after facial injections
Other outcomes:
Locations:
city: Créteil
country: France
facility: MEZI
Study officials:
affiliation: Department of plastic and reconstructive surgery-Henri Mondor Hospital
name: Jean Meningaud, MD.PhD
role: PRINCIPAL_INVESTIGATOR
References: