A Prospective, Randomized, Controlled Two-arm Superiority Study to Evaluate Use of the PEAK PlasmaBlade™ 4.0 in Abdominoplasty
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Acute Thermal Injury Depth
研究概览
简要总结
The objective of this clinical study is to evaluate healing of incisions made with the PEAK PlasmaBlade 4.0 compared to scalpel and traditional electrosurgery (Bovie); to monitor and record key post-operative metrics following abdominoplasty with the PEAK PlasmaBlade 4.0 versus current standard of care (SOC); and to evaluate performance metrics of the PEAK PlasmaBlade 4.0 during abdominoplasty.
详细描述
Abdominoplasty is a cosmetic surgical procedure performed to correct abdominal elastosis with skin and fat redundancy. During the procedure, a scalpel and traditional electrosurgical device are used to cut away this excess skin and fat from the abdomen and the underlying muscles are tightened together with sutures.
The PEAK PlasmaBlade™ uses pulsed radiofrequency (RF) energy to enable precision cutting and coagulating at the point of application, without the thermal damage to surrounding tissues that is normally seen with traditional electrosurgery. The PlasmaBlade has received FDA clearance for use in plastic, general, and ear, nose, and throat (ENT) surgery, and has demonstrated significantly reduced serous drainage in tissue reduction surgeries, like abdominoplasty.
A total of twenty (20) human subjects were recruited from the local community against standardized inclusion/exclusion criteria. Once enrolled, each patient underwent placement of three sets of full-thickness comparison incisions in their abdominal skin with a standard scalpel, PlasmaBlade, and traditional electrosurgery at six (6) and three (3) weeks prior to abdominoplasty, and on the day of surgery under general anesthesia. Subjects were then randomized to undergo abdominoplasty with the PlasmaBlade or the SOC (scalpel and traditional electrosurgery). Following abdominoplasty, harvested healed incisions were submitted for histological analysis and burst strength testing and additional data were recorded in the 10 day post-operative period.
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
- 25 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 25 and 60 years old
- •Physically healthy, stable weight, non-smoker
- •Protruding abdomen, excess fat and skin and/or weak abdominal muscles qualifying for abdominoplasty.
- •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 25 or greater than 60 years old
- •Anticoagulation therapy which cannot be discontinued
- •Smoking (any kind)
- •Diabetes (any type)
- •Infection (local or systemic)
- •Cognitive impairment or mental illness
- •Severe cardiopulmonary deficiencies
- •Known coagulopathy
- •Immunocompromised
- •Kidney disease (any type)
- •Subjects who are pregnant or lactating
- •Currently taking any medication known to affect healing
- •Subjects who are status-post gastric banding or gastric bypass
- •Reproductive age females who will not take acceptable measures to prevent pregnancy during the study.
- •Recent history of abdominal surgery or prior abdominoplasty.
- •Subjects who are known to be HIV or Hepatitis (any) positive
- •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
Acute Thermal Injury Depth
时间窗: Immediately postoperative
Histological samples were created by first incising the area to be resected with all 3 modalities (PEAK PlasmaBlade, electrocautery, and scalpel) at 6 and 3 weeks before the operation. Then, the incised tissue was resected during the abdominoplasty and was assessed by analyzing incisions created in the resected area for histological measures. Acute thermal injury depth was assessed by incising the resected area during the abdominoplasty operation.
Inflammatory Cell Count
时间窗: 0, 3, and 6 weeks
Histological samples were created by first incising the area to be resected with all 3 modalities (PEAK PlasmaBlade, electrocautery, and scalpel) at 6 and 3 weeks before the operation. Then, the incised tissue was resected during the abdominoplasty and was assessed by analyzing incisions created in the resected area for histological measures.
次要结局
- Total Drainage Output(0 to 10 days postoperatively)
- Change in Hemoglobin(Intraoperative)
- Narcotic Consumption(Intraoperative and postoperative (0 to 10 days))
- Postoperative Pain Levels(Postoperative (0 to 10 days))
- Activity Level(Postoperative (0 to 10 days))
- Diet Volume(Postoperative (0 to 10 days))