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NCT04240080 Clinical Trial

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

Wrinkle Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT04240080
Other study ID # 19-011561
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date January 10, 2020
Est. completion date December 2024

Study information
Verified date April 2024
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date December 2024
Est. primary completion date December 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients pursuing aesthetic/therapeutic facial injection procedures (botox/filler) Exclusion Criteria: - Patients undergoing aesthetic facial procedures not requiring needle injection

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Mayo Clinic

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Rate of Bruising/Hematoma Number of subjects to experience bruising/hematoma post facial injection procedure Approximately 7-10 days following the procedure
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