Fractional Radiofrequency for Reduction of Surgical Scar Formation

NCT05897723 | Recruiting FDA Device

• 1 other identifier: VI0120
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Safety and Efficacy of Fractional Radiofrequency for the Reduction of Surgical Scar Formation

Conditions

Surgical Incision

Outcome Measures

Primary Outcomes (2)

• Independent blinded assessment

  Independent blinded evaluator assessment of the surgical scar sites using the Global Aesthetic Improvement Scale (GAIS), comparing follow-up visit photographs for both the treated and untreated sides.

  6-months after treatment

• Principle Investigator (PI) evaluation of the scar(s)

  PI evaluation of the scar(s) using the Manchester Scar Scale (MSS) at 3 and 6 months post-treatment for both the treated and untreated sides. Non-invasive skin assessments will be evaluated to document scar morphology, scar thickness/density and colorimetry for both the treated and untreated sides.

  3- and 6-months after treatment

Secondary Outcomes (5)

• Subject Satisfaction

  3- and 6-months after treatment

• Histological Assessment

  1-, 3- and 6-months after treatment

• Scar Morphology

  Baseline, 3- and 6-months after treatment

• Ultrasonography

  Baseline, 3- and 6-months after treatment

• Colorimetry

  Baseline, 3- and 6-months after treatment

Study Arms (1)

Treatment Group

EXPERIMENTAL

All enrolled subjects will undergo breast reduction or breast mastectomy in which scar assessment will be made after pre-surgical treatment in a split-body design, involving a single treatment of RF application to one side of the surgical area(s) within 24 hours prior to the procedure. The subject will act as their own control, where one surgical area will be treated, and the other will not be and will act as the control. Tissue samples will be biopsied from RF treated skin, as well as non-treated skin, at follow up visits. The samples will be used for histological evaluation to assess tissue structure and regeneration following surgery.

Device: Fractional Radiofrequency

Interventions

Fractional Radiofrequency DEVICE

Fractional Radiofrequency (RF) delivering nano-fractional RF energy, causing fractional ablation and coagulation at the treatment site.

Treatment Group

Eligibility Criteria

• Age: 21 Years - 75 Years
• Gender Eligibility Details: Female subjects undergoing breast reduction or breast mastectomy
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy, female subjects 21-75 years of age who are seeking pre-treatment for the prevention of surgical scars.
• Able to read, understand and voluntarily provide written Informed Consent.
• Able and willing to comply with the treatment/follow-up schedule and requirements.
• Willing to avoid direct sunlight to the treatment area for the duration of the study.
• Women of child-bearing age are required to be using a reliable method of birth control at least 3 months prior to study enrollment and for the duration of the study, and have a negative Urine Pregnancy test at baseline.

You may not qualify if:

• Subjects with any implantable metal device in the treatment area
• Pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body (e.g. cochlear implant).
• Permanent implant in the treated area, such as metal plates and screws, or an injected chemical substance.
• Current or history of any kind of cancer, or dysplastic nevi.
• Severe concurrent conditions, such as cardiac disorders.
• Pregnancy or intending to become pregnant during the study and nursing.
• Impaired immune system due to immunosuppressive diseases, such as AIDS and HIV, or use of immunosuppressive medications.
• History of diseases stimulated by heat, such as recurrent herpes simplex in the treatment area; may be enrolled only following a prophylactic regime.
• Poorly controlled endocrine disorders, such as diabetes.
• Any active condition in the treatment area, such as sores, psoriasis, eczema, and rash.
• History of skin disorders, such as keloids, abnormal wound healing, as well as very dry and fragile skin.
• History of bleeding coagulopathies, or use of anticoagulants.
• Use of isotretinoin (Accutane®) within six months prior to treatment or at physician discretion.
• Treating over tattoo or permanent makeup.
• Excessively tanned skin from sun, tanning beds or tanning creams within the last two weeks.

Sponsors & Collaborators

• Venus Concept: lead

Study Sites (1)

UT Southwestern Medical Center, Department of Plastic Surgery

Dallas, Texas, 75390, United States

RECRUITING

MeSH Terms

Conditions

Surgical Wound

Condition Hierarchy (Ancestors)

Wounds and Injuries

Central Study Contacts

Andrea Biro, MSc.

CONTACT

8889070115; abiro@venusconcept.com

Matthew Gronski, PhD

CONTACT

8889070115; mgronski@venusconcept.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Independent blinded evaluator assessment of the surgical scar sites using the Global Aesthetic Improvement Scale (GAIS), comparing follow-up visit photographs for for both the treated and untreated sides.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Non-randomized, single-center, split-body, evaluator blinded

Study Record Dates

• First Submitted: June 1, 2023
• First Posted: June 9, 2023
• Study Start: September 1, 2023
• Primary Completion: May 31, 2025
• Study Completion: December 31, 2025
• Last Updated: March 28, 2025

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)