Impact of Near-Infrared Vein Mapping on Outcomes and Satisfaction After Botox/Filler Treatment

Mayo Clinic

Status: Withdrawn

Conditions: Wrinkle

Treatments: Device: Accuvein® Veinfinder

Study type: Interventional

Funder types: Other

Identifiers

NCT04240080

19-011561

Details and patient eligibility

About

Researchers are studying how vein mapping impacts patient outcomes and satisfaction after facial injection procedures.

Full description

Facial Botox/filler injections carry risk of puncturing superficial veins, leading to bruising and pain. Our study will investigate the utility of non-invasive vein imaging (specifically near-infrared light reflection) on the incidence of pain/bruising/hematoma and patient satisfaction after facial injections.

The current standard of care for facial injection procedures does not involve any modality of facial venous mapping. Vein mapping is a non-invasive, simple task that takes very little time to conduct. One risk is patient time, however maximum extra time needed will be 5 minutes during the clinical visit. This potential extra time in mind, the benefits far outweigh the risks.

Two cohorts of patients will be prospectively compared following randomization, those who did have pre-procedure venous mapping prior to injection versus those who did not. Data will be analyzed with regard to bruising and swelling following injection, as well as other potential complications such as hematoma or infection, along with patient satisfaction survey information.

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients pursuing aesthetic/therapeutic facial injection procedures (botox/filler)

Exclusion criteria

• Patients undergoing aesthetic facial procedures not requiring needle injection

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Control Goup

No Intervention group

Description:

Subjects will undergo clinically indicated facial injection procedures per standard of care without venous mapping

Intervention Group

Experimental group

Description:

Subjects will undergo clinically indicated facial injection procedure with pre-procedural facial venous mapping by Accuvein® Veinfinder

Treatment:

Device: Accuvein® Veinfinder