Pulsed Dye Laser and Affirm Laser in the Treatment of Abdominoplasty Scars
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Efficacy of PDL vs Affirm Laser vs Combined Laser Treatments in Appearance of Surgical Scar
研究概览
简要总结
The purpose of this study is to examine the effect of using a pulsed dye laser (the VBEAM), a non-ablative laser (the Affirm) and a combination of both lasers to improve the appearance of your surgical scar. Both the pulsed dye laser and Affirm laser are approved by the US Food and Drug Administration (FDA) for the treatment of scars. Surgical scars are a type of scar that can benefit from laser therapy. Redness and the appearance of small blood vessels near the surface of the skin (telangiectasias) develop in such scars as part of the normal healing process and usually spontaneously remit, but often slowly and incompletely. In many cases, lasers can accelerate the clearing of this redness and also improve scar texture.
详细描述
In summary, we will perform a total of three laser treatments. A personal interview, clinical examination, and a photograph will be taken at each visit. At the end of the three treatments, a final personal interview, clinical evaluation and photograph will be taken to document the effects of the laser treatments. At the end of the study, the patient will have the option to receive two additional laser treatments four weeks apart, also at no cost, to the entire scar.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age 18 years and older
- •No significant medical illness
- •Surgical procedure that involves closure of the transverse abdominal incision performed in the department of dermatology and plastic surgery at the Cleveland Clinic main campus.
- •Subjects with the willingness and ability to understand and provide informed consent
排除标准
- •Under 18 years of age
- •Pregnancy or Lactation
- •Subjects currently taking blood thinners or who have had chemotherapy or radiation within the last 6 months
- •Subjects with liver/kidney disease, diabetes mellitus, hypertension, connective tissue disease or who are immunocompromised
- •Subjects with a known susceptibility to keloid formation or hypertrophic scarring
- •Subjects who are unable to understand the protocol or to give informed consent
- •Subjects with mental illness
- •Subjects with obvious non-healing wound
研究组 & 干预措施
Pulsed dye laser
PDL Patient will be have scar treated with pulsed dye laser.
干预措施: pulsed dye laser (Device)
Affirm laser
Patient will be have scar treated with Affirm Laser
干预措施: Affirm Laser (Device)
combined PDL and Affirm Lasers
Patient will be have scar treated with combined Affirm + PDL
干预措施: combined PDL and Affirm Lasers (Device)
Placebo
Patient will be have scar treated with Placebo
干预措施: Placebo (Other)
结局指标
主要结局
Efficacy of PDL vs Affirm Laser vs Combined Laser Treatments in Appearance of Surgical Scar
时间窗: 1 year
The purpose of this study is to determine the efficacy of the 585-nm pulsed dye laser (PDL) and 1440-nm Affirm laser in the treatment of surgical scars starting one week after closure of transverse abdominal incision.
次要结局
未报告次要终点