A Prospective, Non-blinded, Randomized Controlled Post-market Study Designed to Compare the Use of the Zip Surgical Skin Closure Device Versus Sutures for Skin Closure in Subjects Who Undergo a Cesarean Section Procedure.
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Cosmetic Visual Analogue Scale (CVAS)
研究概览
简要总结
The study will evaluate the ZipLine Medical Surgical Skin Closure device (Zip)versus sutures when utilized for skin layer closure during wound closure of Cesarean Section Procedure.
详细描述
Cesarean-section birth is a very invasive surgical procedure. While the desired outcome focuses primarily on the successful delivery of a healthy baby and maintenance of the mother's health, the surgery involves a complex surgical closure process, starting with the uterus, and progressing through several layers of traditionally suture closure in several tissue planes. A successful closure results in no surgical site complications, with good patient comfort and a minimal scar being a desired outcome.
Conventional skin closure methods such as sutures are effective but have drawbacks. It has been suggested that the ideal method of wound / incision closure should be:
- fast
- non-traumatic
- minimally or non-invasive
- associated with a low incidence of adverse events such as dehiscence and infection
- yielding acceptable cosmetic results
ZipLine Medical, Inc. is a Campbell, California-based company that has developed a novel, non-invasive skin closure device called Zip Surgical Skin Closure to replace sutures, staples and glue for closure of the skin layer for surgical incisions or laceration repair. In the USA, the device has been classified by the FDA as a Class I, 510(k) Exempt device and began commercial use in the USA in April 2013.
The ZipLine Device has been clinically demonstrated benefits include (references included later in this document):
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
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients 18 years of age and older
- •Primary C-section
- •Patients willing and able to complete study protocol
排除标准
- •Known bleeding disorder not caused by medication
- •Known personal or family history of keloid formation or scar hypertrophy
- •Known allergy or hypersensitivity to non-latex skin adhesives
- •Atrophic skin deemed clinically prone to blistering
- •Any skin disorder affecting wound healing
- •Any other condition that in the opinion of the investigator would make a particular subject unsuitable for this study
- •Emergent C-Section
- •Non-primary C-Section
研究组 & 干预措施
Zip Closure Device
The Zip device is a non-invasive, single use, sterile medical device for closure of the skin layer for surgical incisions or laceration repair.
干预措施: Zip Surgical Skin Closure Device (Device)
Conventional Sutures
Conventional subdermal (subcuticular) absorbable sutures
干预措施: Conventional Sutures (Other)
结局指标
主要结局
Cosmetic Visual Analogue Scale (CVAS)
时间窗: 3 months
100-mm Cosmetic Visual Analogue Scale (CVAS) for incision appearance
Time of Procedure Closure
时间窗: Procedure Closure - Zip or Suture touches skin until skin is closed
Upon closure of the Cesarean incision - Zip or Suture touches skin to close incision
次要结局
- Surgeon Closure Method Satisfaction(Procedure, 3-5 days, 3 months)
- Patient Pain and Discomfort by Subject Questionnaire(3-5 days, 14 days, 3 months)
- Incidence and severity of Adverse Events(Procedure, 3-5 days, 14 days, 3 months)
- Patient Closure Method Satisfaction(3-5 days, 14 days, 3 months)