NCT01826942终止不适用
Scar Prevention Using Fractional Carbon Dioxide Laser Treatment
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Scar appearance by blinded evaluation of photographs of the three month follow-up visit
研究概览
简要总结
In this study the investigators intend to determine the impact of fractional CO2 laser treatment on the edges of a fresh wound during surgical area closure on thin skin (e.g. face, hands, arms, thorax, etc.) and on thick skin (abdominoplasty procedure) on scar formation. The investigators will also evaluate the effect of shallow fractional laser treatment versus deep parameters settings. If effective treatments could be performed at time of surgery, this would result in both time and cost saving to the patient and to the healthcare system and will improve patient's self-image post surgeries.
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or Females
- •At least 18 and no more than 65 years old
- •The surgical area closure in these subjects should be at least 4cm
- •Type of surgery scheduled:
- •Site 1: Surgical area closure on thin skin, including areas that require motion (e.g. face, hands, arms, thorax, etc.) Site 2: Surgical area closure on thick skin (abdominoplasty procedure)
- •Willing to comply with study dosing and complete the entire course of the study
排除标准
- •Active bacterial, fungal, or viral infection in the treatment area
- •Active cold sores, or herpes in the treatment area
- •Recent excessive exposure to sunlight or artificial UV light (e.g.: use of tanning beds/booths and/or sunbathing) or expectations of tanning during the time of the study
- •History of skin cancer, unless the surgical procedure of issue is for cancer treatment purposes.
- •History of or the presence of any skin condition/disease that might interfere with the diagnosis or evaluation of study parameters (i.e., atopic dermatitis, eczema, psoriasis)
- •Treatment with a systemic retinoid within the past year (e.g., Accutane®, Roche Dermatologics)
- •History or presenting with a keloid scar
- •Any current or recent treatment for cancer, unless the surgical procedure of issue is for cancer treatment purposes.
- •Any uncontrolled systemic disease. A potential subject in whom therapy for a systemic disease is not yet stabilized will not be considered for entry into the study
- •Significant history or current evidence of a medical, psychological or other disorder that, in the investigator's opinion, would preclude enrollment into the study.
- •Subject planning any other cosmetic procedure to the study area during the study period, other than the treatments that will be performed by the investigator
- •Female subject who is pregnant, nursing an infant or is less than 6 months after termination of breast feeding
- •Small surgical closure (<4cm)
结局指标
主要结局
Scar appearance by blinded evaluation of photographs of the three month follow-up visit
时间窗: three month follow-up
次要结局
未报告次要终点
研究者
研究点 (2)
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