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

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

Detailed Description
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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.

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

Conditions
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Wrinkle

Intervention / Treatment
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* Device: Accuvein® Veinfinder


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients pursuing aesthetic/therapeutic facial injection procedures (botox/filler) Exclusion Criteria: Patients undergoing aesthetic facial procedures not requiring needle injection

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Goup<br>Subjects will undergo clinically indicated facial injection procedures per standard of care without venous mapping | |
| Experimental: Intervention Group<br>Subjects will undergo clinically indicated facial injection procedure with pre-procedural facial venous mapping by Accuvein® Veinfinder | Device: Accuvein® Veinfinder<br>* Near-infrared light reflection utilized by healthcare providers to see superficial veins under the skin.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction | Measured using the self-reported FACE-Q satisfaction score, using a scale of 1=definitely disagree and 4=definitely agree | Approximately 7-10 days following the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Bruising/Hematoma | Number of subjects to experience bruising/hematoma post facial injection procedure | Approximately 7-10 days following the procedure |