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Fractional Radiofrequency for Reduction of Surgical Scar Formation

Primary Purpose

Surgical Incision

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fractional Radiofrequency
Sponsored by
Venus Concept
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Surgical Incision

Eligibility Criteria

21 Years - 75 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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.

Sites / Locations

  • UT Southwestern Medical Center, Department of Plastic Surgery

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment Group

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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

Full Information

First Posted
June 1, 2023
Last Updated
June 1, 2023
Sponsor
Venus Concept
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1. Study Identification

Unique Protocol Identification Number
NCT05897723
Brief Title
Fractional Radiofrequency for Reduction of Surgical Scar Formation
Official Title
Safety and Efficacy of Fractional Radiofrequency for the Reduction of Surgical Scar Formation
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 2023 (Anticipated)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
August 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Venus Concept

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Incision

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Non-randomized, single-center, split-body, evaluator blinded
Masking
None (Open Label)
Masking Description
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.
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Fractional Radiofrequency
Intervention Description
Fractional Radiofrequency (RF) delivering nano-fractional RF energy, causing fractional ablation and coagulation at the treatment site.
Primary Outcome Measure Information:
Title
Independent blinded assessment
Description
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.
Time Frame
6-months after treatment
Title
Principle Investigator (PI) evaluation of the scar(s)
Description
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.
Time Frame
3- and 6-months after treatment
Secondary Outcome Measure Information:
Title
Subject Satisfaction
Description
Subject satisfaction of treatment using the Subject Satisfaction Scale
Time Frame
3- and 6-months after treatment
Title
Histological Assessment
Description
Histological assessment of the treated and the untreated (control) area.
Time Frame
1-, 3- and 6-months after treatment
Title
Scar Morphology
Description
Scar morphology will be digitally analyzed using 3D photography camera
Time Frame
Baseline, 3- and 6-months after treatment
Title
Ultrasonography
Description
High ultrasonography will be used to analyze scar thickness, epidermal thickness and skin density
Time Frame
Baseline, 3- and 6-months after treatment
Title
Colorimetry
Description
o Colorimetry assessment will be used to establish a clinically acceptable objective assessment of patients' scars
Time Frame
Baseline, 3- and 6-months after treatment

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Female subjects undergoing breast reduction or breast mastectomy
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Andrea Biro, MSc.
Phone
8889070115
Email
abiro@venusconcept.com
First Name & Middle Initial & Last Name or Official Title & Degree
Matthew Gronski, PhD
Phone
8889070115
Email
mgronski@venusconcept.com
Facility Information:
Facility Name
UT Southwestern Medical Center, Department of Plastic Surgery
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer Barillas
Phone
214-645-8907
Ext
9132
Email
Jennifer.Barillas@utsouthwestern.edu

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No IPD sharing plan.

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Fractional Radiofrequency for Reduction of Surgical Scar Formation

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