Fractional Radiofrequency for Surgical Scars

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Venus Concept

No Placebo Group

Trial Summary

What is the purpose of this trial?Safety and Efficacy of Fractional Radiofrequency for the Reduction of Surgical Scar Formation

Eligibility Criteria

This trial is for healthy women aged 21-75 looking to prevent surgical scars. Participants must avoid sun exposure on the treatment area, use reliable birth control, and not be pregnant or nursing. Exclusions include cancer history, severe conditions like heart disorders, skin issues in the treatment area, certain medications including isotretinoin within six months, metal implants near the treatment site, uncontrolled diabetes, bleeding disorders, pacemakers or similar devices.

Inclusion Criteria

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

Able to read, understand and voluntarily provide written Informed Consent

Able and willing to comply with the treatment/follow-up schedule and requirements

+2 more

Exclusion Criteria

Pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body (e.g. cochlear implant)

I have a permanent implant like metal plates or screws in the treated area.

Subjects with any implantable metal device in the treatment area

+12 more

Participant Groups

The study tests the safety and effectiveness of Fractional Radiofrequency in reducing scar formation after surgery. It's a preventive pre-treatment aimed at minimizing scarring for those undergoing surgical procedures.

1Treatment groups

Experimental Treatment

Group I: Treatment GroupExperimental Treatment1 Intervention

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.