Safety and Efficacy of Fractional Radiofrequency for the Reduction of Surgical Scar Formation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Independent blinded assessment
研究概览
简要总结
Safety and Efficacy of Fractional Radiofrequency for the Reduction of Surgical Scar Formation
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Independent blinded evaluator assessment of the surgical scar sites using the Global Aesthetic Improvement Scale (GAIS), comparing follow-up visit photographs for for both the treated and untreated sides.
入排标准
- 年龄范围
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy, female subjects 21-75 years of age who are seeking pre-treatment for the prevention of surgical scars.
- •Able to read, understand and voluntarily provide written Informed Consent.
- •Able and willing to comply with the treatment/follow-up schedule and requirements.
- •Willing to avoid direct sunlight to the treatment area for the duration of the study.
- •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.
排除标准
- •Subjects with any implantable metal device in the treatment area
- •Pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body (e.g. cochlear implant).
- •Permanent implant in the treated area, such as metal plates and screws, or an injected chemical substance.
- •Current or history of any kind of cancer, or dysplastic nevi.
- •Severe concurrent conditions, such as cardiac disorders.
- •Pregnancy or intending to become pregnant during the study and nursing.
- •Impaired immune system due to immunosuppressive diseases, such as AIDS and HIV, or use of immunosuppressive medications.
- •History of diseases stimulated by heat, such as recurrent herpes simplex in the treatment area; may be enrolled only following a prophylactic regime.
- •Poorly controlled endocrine disorders, such as diabetes.
- •Any active condition in the treatment area, such as sores, psoriasis, eczema, and rash.
- •History of skin disorders, such as keloids, abnormal wound healing, as well as very dry and fragile skin.
- •History of bleeding coagulopathies, or use of anticoagulants.
- •Use of isotretinoin (Accutane®) within six months prior to treatment or at physician discretion.
- •Treating over tattoo or permanent makeup.
- •Excessively tanned skin from sun, tanning beds or tanning creams within the last two weeks.
研究组 & 干预措施
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.
干预措施: Fractional Radiofrequency (Device)
结局指标
主要结局
Independent blinded assessment
时间窗: 6-months after treatment
Independent blinded evaluator assessment of the surgical scar sites using the Global Aesthetic Improvement Scale (GAIS), comparing follow-up visit photographs for both the treated and untreated sides.
Principle Investigator (PI) evaluation of the scar(s)
时间窗: 3- and 6-months after treatment
PI evaluation of the scar(s) using the Manchester Scar Scale (MSS) at 3 and 6 months post-treatment for both the treated and untreated sides. Non-invasive skin assessments will be evaluated to document scar morphology, scar thickness/density and colorimetry for both the treated and untreated sides.
次要结局
- Histological Assessment(1-, 3- and 6-months after treatment)
- Scar Morphology(Baseline, 3- and 6-months after treatment)
- Ultrasonography(Baseline, 3- and 6-months after treatment)
- Subject Satisfaction(3- and 6-months after treatment)
- Colorimetry(Baseline, 3- and 6-months after treatment)