Using radiofrequency to reduce surgical scars

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

This study tests if a special radiofrequency treatment can help reduce scars in women having breast reduction or mastectomy surgery.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 21 Years to 75 Years
• Sex: Female
• Sponsor: Venus Concept (Industry-sponsored)
• Locations: 1 site (Dallas, Texas)
• Trial ID: NCT05897723 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and efficacy of fractional radiofrequency treatment to minimize surgical scar formation in patients undergoing breast reduction or mastectomy. Up to 20 healthy female subjects will receive a single radiofrequency treatment on one side of the surgical area within 24 hours before their procedure, while the other side will remain untreated as a control. Tissue samples will be collected from both treated and untreated areas for histological analysis to assess the impact of the treatment on tissue structure and regeneration post-surgery.

Who should consider this trial

Good fit: Ideal candidates are healthy women aged 21-75 seeking preventive treatment for surgical scars prior to breast surgery.

Not a fit: Patients with any implantable metal devices or a history of cancer may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the appearance of surgical scars for patients undergoing breast surgery.

How similar studies have performed: While the use of radiofrequency for scar reduction is promising, this specific approach has not been extensively tested in prior studies.

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.

Where this trial is running

Dallas, Texas

• UT Southwestern Medical Center, Department of Plastic Surgery — Dallas, Texas, United States (Recruiting)

Study contacts

• Study coordinator: Andrea Biro, MSc.

Conditions Surgical Incision