Closure of Skin Incision Using CO2 Laser
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 4
- 主要终点
- Primary study endpoint will be to establish the safety of using the Temperature Controlled Laser Soldering System for skin bonding and wounds closure. Safety will be established by paucity of serious adverse events and adverse events.
研究概览
简要总结
The purpose of this study is to evaluate the safety and effectiveness of using Temperature Controlled Laser Soldering System for soft tissue bonding.
详细描述
Skin incisions can be closed by a variety of method which create temporary approximation of the wound edges until natural healing process ensue and reach a phase, where it is closed and can sustain the daily tensile forces.
The wound closure devices include sutures, staples, tapes, tissue adhesives. The Applied Physics group at the Tel Aviv University has developed a Temperature Controlled CO2 Laser Soldering system for soft tissue bonding.
This system includes features that make laser soldering suitable for clinical use. The Temperature Controlled Laser Soldering System is composed of CO2 fiberoptic laser device, Infrared fiber-optic radiometer, a computerized temperature control program, propriety grip device (Clamps) and concentrated Human Albumin as a soldering agent.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male/Female age 18-
- •Subject is scheduled for laparoscopic cholecystectomy surgery.
- •Subject able to comprehend and sign informed consent for participation in this study.
- •Ability to comply with the study procedures and follow-up visits
排除标准
- •Subject has a history of hypertrophic or keloid scar formation
- •Subject is a pregnant and/or nursing woman
- •Subject has a known allergy to blood products
- •Subject is suffering from a bleeding disorders or using anticoagulant medications
- •Subject is suffering from hepatic or renal disorder
- •Subject is suffering from rheumatic and / or collagen disorder
- •Subject is using steroids
- •Subject is suffering from immunosuppressive disorder
- •Subject is suffering from Ischemic Heart Disease (IHD)
- •Subject is suffering from neoplastic disorder
- •Subject who has had an active illness within 4 weeks of study enrollment
- •Subject is participating in another study for an investigational drug and/or device within 3 months of study enrollment
- •Any condition which would make the participant, in the opinion of the investigator, unsuitable for the study.
结局指标
主要结局
Primary study endpoint will be to establish the safety of using the Temperature Controlled Laser Soldering System for skin bonding and wounds closure. Safety will be established by paucity of serious adverse events and adverse events.
时间窗: 3 months
次要结局
- Re-intervention: A subject is scored a success (1) if he had No Re-intervention by 3 months; otherwise he is scored a failure (0).(3 months)
- Wound dehiscence of at least 50% of wound length(3 months)
研究者
Avraham Katzir
Head of the applied physics group
Tel Aviv University