Fractional Radiofrequency for Reduction of Surgical Scar Formation

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

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

Study Overview

• Status: Recruiting
• Conditions: Surgical Incision
• Intervention / Treatment: Device: Fractional Radiofrequency

Detailed Description

The study will evaluate up to 20 subjects scheduled to undergo breast reduction or breast mastectomy in which scar assessment can be made after pre-surgical treatment in a split-body design. The study will involve a single treatment of radiofrequency (RF) applied 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 the 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.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Andrea Biro, MSc.; Phone Number: 8889070115; Email: abiro@venusconcept.com
• Study Contact Backup: Name: Matthew Gronski, PhD; Phone Number: 8889070115; Email: mgronski@venusconcept.com

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75390
      • Recruiting
      • UT Southwestern Medical Center, Department of Plastic Surgery
      • Contact: Jennifer Barillas; Phone Number: 9132 214-645-8907; Email: Jennifer.Barillas@utsouthwestern.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Healthy, female subjects 21-75 years of age who are seeking pre-treatment for the prevention of surgical scars.
2. Able to read, understand and voluntarily provide written Informed Consent.
3. Able and willing to comply with the treatment/follow-up schedule and requirements.
4. Willing to avoid direct sunlight to the treatment area for the duration of the study.
5. 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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subject Satisfaction	Subject satisfaction of treatment using the Subject Satisfaction Scale	3- and 6-months after treatment
Histological Assessment	Histological assessment of the treated and the untreated (control) area.	1-, 3- and 6-months after treatment
Scar Morphology	Scar morphology will be digitally analyzed using 3D photography camera	Baseline, 3- and 6-months after treatment
Ultrasonography	High ultrasonography will be used to analyze scar thickness, epidermal thickness and skin density	Baseline, 3- and 6-months after treatment
Colorimetry	o Colorimetry assessment will be used to establish a clinically acceptable objective assessment of patients' scars	Baseline, 3- and 6-months after treatment

Collaborators and Investigators

• Sponsor: Venus Concept

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2023
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: June 1, 2023
• First Submitted That Met QC Criteria: June 1, 2023
• First Posted (Actual): June 9, 2023

Study Record Updates

• Last Update Posted (Actual): March 27, 2024
• Last Update Submitted That Met QC Criteria: March 25, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Surgical Wound
• Other Study ID Numbers: VI0120

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No IPD sharing plan.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes