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

Overview

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

Full Title of Study: “The Impact of Near-Infrared Vein Mapping on Outcomes and Satisfaction After Botox/Filler Treatment”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 1, 2021

Detailed 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.

Interventions

  • Device: Accuvein┬« Veinfinder
    • Near-infrared light reflection utilized by healthcare providers to see superficial veins under the skin.

Arms, Groups and Cohorts

  • No Intervention: Control Goup
    • Subjects will undergo clinically indicated facial injection procedures per standard of care without venous mapping
  • Experimental: Intervention Group
    • Subjects will undergo clinically indicated facial injection procedure with pre-procedural facial venous mapping by Accuvein┬« Veinfinder

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

Inclusion Criteria

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

Exclusion Criteria

  • Patients undergoing aesthetic facial procedures not requiring needle injection

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Mayo Clinic
  • Provider of Information About this Clinical Study
    • Principal Investigator: William J. Casey, III, Principal Investigator – Mayo Clinic
  • Overall Official(s)
    • William Casey III, MD, Principal Investigator, Mayo Clinic
  • Overall Contact(s)
    • William Casey, MD, 480-342-2976, Casey.williamjoseph@mayo.edu

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