Clinical trial NCT05897723: 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
Overall status: RECRUITING
Phase: NA
Conditions: Surgical Incision
Lead sponsor: Venus Concept
Sponsor class: INDUSTRY
First posted: 2023-06-09
Enrollment: 20
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Non-randomized, single-center, split-body, evaluator blinded
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Independent blinded assessment
timeFrame: 6-months after treatment
measure: Principle Investigator (PI) evaluation of the scar(s)
timeFrame: 3- and 6-months after treatment
Secondary outcomes:
measure: Subject Satisfaction
timeFrame: 3- and 6-months after treatment
measure: Histological Assessment
timeFrame: 1-, 3- and 6-months after treatment
measure: Scar Morphology
timeFrame: Baseline, 3- and 6-months after treatment
measure: Ultrasonography
timeFrame: Baseline, 3- and 6-months after treatment
measure: Colorimetry
timeFrame: Baseline, 3- and 6-months after treatment
Other outcomes:
Locations:
city: Dallas
country: United States
facility: UT Southwestern Medical Center, Department of Plastic Surgery
state: Texas
Study officials:
References: