Evaluation of the BioWeld1 System as a Method for Surgical Incision Closure
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Safety
研究概览
简要总结
The purpose of this study is to assess the safety and performance of the BioWeld1 System procedure for surgical incision closure of the skin in women scheduled for elective C-section procedure.
详细描述
In every surgical procedure, there is a need to close the incision that was made. Current methods for incision closure include stitching, gluing and stapling. Some of these methods are time consuming, have potential for infection and may leave a significant scar. The bioWeld1 technology suggests a new approach for incision closure. It is a novel medical device that consists of a Chitosan film and the BioWeld1 plasma ejecting device. The Chitosan film is intended to be applied to the skin incision, while the BioWeld1device is used for welding the Chitosan to the skin by means of cold plasma technology.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age between 20 to 40 years old.
- •Women scheduled for child delivery using an elective C- section.
- •Women in their first or second pregnancy having a C-section for the first time
- •Healthy women with no systemic diseases such as diabetes, heart disease etc.
- •Women with average weight, BMI prior pregnancy of 18.5-
- •Women with no skin diseases
- •Subject understands the study requirements and the treatment procedures and provides written Informed Consent before any study-specific tests or procedures are performed.
- •The subject commits to return for the scheduled post-operative follow-up visits at the clinic
排除标准
- •Women intended for any abdominal surgery other than C-section procedure
- •Women intended for C-section procedure for other purpose than child delivery
- •Any prior C-section procedure for any purpose
- •Women Received/Receiving radiotherapy or chemotherapy of any kind.
- •Women receiving steroids or any other medication that interferes with wound healing.
- •Women receiving Acutan in the last half year.
- •Women with bleeding diathesis or hypercoagulable state.
- •Women with prior cosmetic or medical treatment in the target area (e.g. phosphatydilcholine injections).
- •Women suffering from Thrombocytopenia (platelets count<100,000/mm3) pre-procedure.
- •Women who is currently participating or have participated in an investigational study, other than this study, within the past 60 days.
- •Psychiatric background.
- •Intra operative exclusion criteria:
- •Severe excessive bleeding from the wound
- •Patient is not eligible for an experimental closure according to the physician discretion.
研究组 & 干预措施
BioWeld1 System
干预措施: BioWeld1 System (Device)
结局指标
主要结局
Safety
时间窗: Within 21 days post procedure
Frequency and severity of incision closure procedure-related adverse events (burns, wound dehiscence or need for additional surgical procedure of the skin wound).
次要结局
- Performance(At 21 days post procedure)