Early Carbon Dioxide Laser Therapy for Alleviation of Incisional Scar Burden
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Change in Vancouver Scar Scale Score
研究概览
简要总结
This is a prospective, randomized pilot study of patients who will undergo either early or late incisional laser therapy after breast reduction surgery to alleviate scar burden at NYU Langone Medical Center. The purpose of this study is to see how well carbon dioxide (CO2) laser therapy works at preventing scar formation after surgery.CO2 laser therapy is currently being used by dermatologists and plastic surgeons to help with scarring after acne and to rejuvenate the face; its benefits are now being explored by medical professionals in dermatology and cosmetic surgery to prevent scarring after surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients of all ethnic origins will be considered, although certain ethnic groups will be preferentially excluded more than others such as black and South Asian patients due to our exclusion criteria related to darker skin individuals (see below).
- •Patients undergoing bilateral breast reduction surgery
排除标准
- •Males will be excluded from this study as male patients rarely undergo breast reduction surgery. When males do undergo breast reduction surgery for gynecomastia, it is often unilateral, and is performed with several techniques and incision types that are not typical employed during female breast reduction. Thus, for this study, only female patients will be considered (see below).
- •Any patient enrolled in this study who shows evidence of delayed wound healing, dehiscence, or post operative infection at the first post operative visit will be excluded
- •Patients with darker skin (Fitzpatrick IV and above), which is a well-known contraindication to laser therapy
- •Pregnant patients
- •Patients who have had prior breast surgery
- •Patients who have had prior chest/breast irradiation
- •Patients with the following diseases which interferes with wound healing: prior hypertrophic scarring/keloids, type I or type II Diabetes Mellitus, autoimmune diseases/collagen vascular diseases
- •Patients who are active smokers
- •Patients using blood thinners that cannot be stopped
- •Patients who have used aspirin within a week of the procedure date
结局指标
主要结局
Change in Vancouver Scar Scale Score
时间窗: 1 Week to Post Laser 1-Year
Total of score of each measure below: * Pigmentation (0-2) Normal 0 Hypopigmentation 1 Hyperpigmentation 2 * Vascularity (0-3) Normal 0 Pink 1 Red 2 Purple 3 * Pliability (0-5) Normal 0 Supple 1 Yielding 2 Firm 3 Banding 4 Contracture 5 * Height (0-3) Normal (flat) 0 0-2 mm 1 2-5 mm 2 \>5 mm 3
次要结局
未报告次要终点