A Prospective, Randomized, Controlled Study to Evaluate Use of the PEAK PlasmaBlade 4.0 in Bilateral Breast Reduction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 14
- 主要终点
- Postoperative Pain
研究概览
简要总结
The objective of this clinical study is to evaluate the operative performance of the PEAK PlasmaBlade 4.0 during bilateral breast reduction; to monitor and record post-operative pain, adverse events and skin scarring following surgery; and compare these outcomes to the current standard of care (SOC).
详细描述
Bilateral breast reduction is a surgical procedure performed to remove excess breast tissue from both female breasts for therapeutic or cosmetic indications. The purpose of the breast reduction is to decrease the weight of the breasts and restructure the breast tissue for a more favorable appearance. Typically, a scalpel is used for the skin incision and a traditional electrosurgical device is used to cut away any excess tissue.
The PEAK PlasmaBlade™ uses pulsed radiofrequency (RF) energy and a highly-insulated handpiece design to enable precision cutting and coagulation at the point of application. The PlasmaBlade has received FDA clearance for use in plastic, general, and ear, nose, and throat (ENT) surgery, and has demonstrated a significantly reduced thermal injury profile in incised tissue compared to traditional electrosurgical devices. It is hypothesized that this benefit may improve the post-operative outcome of patients undergoing bilateral breast reduction.
A total of forty-five (45) subjects were enrolled into the study. Forty-three (43) underwent bilateral breast reduction, and two (2) subjects were withdrawn prior to surgery. Enrollment and surgeries took place between 18 September 2009 and 12 August 2011. Potential subjects were screened against the inclusion and exclusion criteria of the study protocol and were required to provide informed consent prior to enrollment. Following enrollment, subject operative sites were prospectively randomized to the SOC or PlasmaBlade (PB or PEAK) study groups and scheduled for bilateral breast reduction. Subjects were unaware of which device was used on which breast. Subjects were required to attend two follow-up visits after surgery, approximately one and six weeks following 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
- 20 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age between 20 and 60
- •Physically healthy, stable weight, non-smoker
- •Desiring bilateral breast reduction
- •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.
- •Female subjects must either be no longer capable of reproduction, or taking acceptable measures to prevent pregnancy during the study, and have a negative pregnancy test prior to participation in the study.
排除标准
- •Age younger than 20 or greater than 60 years old
- •Anticoagulation therapy which cannot be discontinued
- •Smoking (any kind)
- •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 are status-post gastric banding or gastric bypass
- •Currently enrolled in another investigational device or drug trial
- •Unable to follow instructions or complete follow-up
结局指标
主要结局
Postoperative Pain
时间窗: 0 to 10 days postoperative
The difference in pain was measured by visual analog scale for 24 hours post-operatively and for 10 post-operative days twice daily between the SOC and PlasmaBlade operative sites. Wong-Baker FACES Visual Analog Scale, 0 (no hurt) to 10 (hurts worst). The results represent the mean of each subject's mean pain scores over 10 days.
次要结局
- Estimated Blood Loss(Intraoperative)
- Operative Time(Intraoperative)
- Amount of Tissue Removed(Intraoperative)
- Dissection Performance(Intraoperative)