Fractional Radiofrequency for Reduction of Surgical Scar Formation
NCT ID: NCT05897723
Last Updated: 2025-03-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
20 participants
INTERVENTIONAL
2023-09-01
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
Fractional Radiofrequency
Fractional Radiofrequency (RF) delivering nano-fractional RF energy, causing fractional ablation and coagulation at the treatment site.
Interventions
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Fractional Radiofrequency
Fractional Radiofrequency (RF) delivering nano-fractional RF energy, causing fractional ablation and coagulation at the treatment site.
Eligibility Criteria
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Inclusion Criteria
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
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.
21 Years
75 Years
FEMALE
Yes
Sponsors
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Venus Concept
INDUSTRY
Responsible Party
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Locations
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UT Southwestern Medical Center, Department of Plastic Surgery
Dallas, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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VI0120
Identifier Type: -
Identifier Source: org_study_id
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