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Fractional Radiofrequency for Surgical Scars

N/A

Recruiting

Research Sponsored by Venus Concept

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1-, 3- and 6-months after treatment

Awards & highlights

Study Summary

This trial found that fractional radiofrequency was safe and effective in reducing surgical scarring.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

While specific side effects are not listed here, fractional radiofrequency treatments may typically cause temporary redness, swelling at the treated area or changes in pigmentation. There could also be a risk of burns if not done correctly.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1-, 3- and 6-months after treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1-, 3- and 6-months after treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1-, 3- and 6-months after treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Independent blinded assessment

Principle Investigator (PI) evaluation of the scar(s)

Secondary outcome measures

Colorimetry

Histological Assessment

Scar Morphology

+2 more

Trial Design

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.

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Venus ConceptLead Sponsor

34 Previous Clinical Trials

1,322 Total Patients Enrolled

Media Library

Treatment Group Clinical Trial Eligibility Overview. Trial Name: NCT05897723 — N/A

Surgical Incisions Research Study Groups: Treatment Group

Surgical Incisions Clinical Trial 2023: Treatment Group Highlights & Side Effects. Trial Name: NCT05897723 — N/A

Treatment Group 2023 Treatment Timeline for Medical Study. Trial Name: NCT05897723 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this scientific research accept individuals aged 50 or older?

"According to the specified eligibility criteria, only individuals between 21 and 75 years old can join this trial. There are 8 specialised trials for those under 18 and 67 studies catered towards patients above 65."

Answered by AI

What is the ultimate objective of this research investigation?

"According to the data provided by Venus Concept, this trial's primary outcome will be a 6-month post-treatment evaluation of scarring from the Principle Investigator. Additional metrics for assessment include Histological Assessment which considers differences between treated and untreated areas, Scar Morphology which is evaluated using 3D photography camera technology, and Ultrasonography that assesses skin density in addition to thickness."

Answered by AI

Is there a possibility of my being accepted into this experiment?

"To be eligible for this experiment, applicants will need to have undergone a surgical procedure and must not exceed 75 years of age. This trial is looking to accept around 20 participants."

Answered by AI

Are applications still being accepted for this clinical experiment?

"This investigation, which was initially posted on June 1st 2023 and last updated the same day, is not taking new participants. Nevertheless, there are presently 71 other clinical trials that accept volunteers."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Fractional Radiofrequency for Reduction of Surgical Scar Formation

2023. "Fractional Radiofrequency for Reduction of Surgical Scar Formation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05897723.

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