A Prospective, Randomized, Controlled Study to Evaluate Cutaneous Scar Quality Following Bilateral Breast Reduction With the PEAK PlasmaBlade 4.0
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Scar Quality
研究概览
简要总结
The objective of this clinical study is to evaluate scar quality following incision with the PEAK PlasmaBlade 4.0 using the Patient and Observer Scar Assessment Scale (POSAS), and to compare these results to equivalently-aged scars formed following incision with a standard scalpel.
详细描述
Subjects attended one of two evaluation dates scheduled on January 21, 2011 and February 23, 2011. During this visit, subjects gave informed consent and were instructed on evaluating their breast reduction scars using the Patient Scar Assessment Scale. Following subjects' self-evaluation, each subject was evaluated by three evaluators using the Observer Scar Assessment Scale.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 70
- •Physically healthy, stable weight
- •Non-smokers, or prior smokers who stopped smoking at least two weeks prior to surgery.
- •Subject must understand the nature of the procedure and provide written informed consent prior to the procedure.
- •Subject must be willing and able to comply with specified follow-up evaluations.
- •Subjects who have participated in the PEAK PlasmaBlade bilateral breast reduction study.
排除标准
- •Age younger than 18 or greater than 70 years old
- •Anticoagulation therapy which cannot be discontinued
- •Smoking (continuous; any substance)
- •Infection (local or systemic)
- •Cognitive impairment or mental illness
- •Severe cardiopulmonary deficiencies
- •Known coagulopathy
- •Immunocompromised
- •Prior history of breast cancer
- •Kidney disease (any type)
- •Currently taking any medication known to affect healing
- •Subjects who did not participated in the PEAK PlasmaBlade bilateral breast reduction study
- •Unable to follow instructions or complete follow-up
结局指标
主要结局
Scar Quality
时间窗: 0-18 months following breast reduction surgery
The primary endpoint will be the difference in scar quality (color, thickness, stiffness, pliability, etc.) between the scalpel and PlasmaBlade skin incisions.
次要结局
未报告次要终点