NCT03201536撤回不适用
ZipLine Incision Approzimation Vs. Suture:Zips3 Physician Preference Study
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 3
- 主要终点
- Wound healing
研究概览
简要总结
Zipline incision approximation vs. Suture -- zips 3 study. A prospective, multi-site, non-blinded, randomized controlled, study designed to evaluate user preferences associated with use of the zipline 3 system versus conventional suturing for incision closure.
详细描述
The objective of this study is to evaluate user preferences associated with the ZipLine 3 system versus conventional suture placement.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients between 18 and 75 years of age
- •In generally good health
- •Willing to be evaluated in 5-14 days and 3-months post op
- •Patient requiring a non-emergent skin incision or biopsy
- •Maximum excision size 1.5x3.0 cm
- •Requiring 4-0 or smaller suture for closure
- •In area of body trunk or extremities with low mobility and tension
排除标准
- •Facial Incisions or incisions in high stress or tension areas
- •Previously diagnosed peripheral vascular disease
- •Insulin-dependent diabetes mellitus
- •Known bleeding diathesis
- •Known personal or family history of keloid formation or scar hypertrophy
- •Known allergy or hypersensitivity to adhesives
- •Presently taking steroids, immune stimulants, beta blockers, or anticoagulants
- •Atrophic skin deemed clinically prone to blistering
- •Any skin disorder affecting wound healing
- •Incisions requiring dermal sutures
- •Any other condition that in the opinion of the investigator would make a particular patient unsuitable for this study
研究组 & 干预措施
sutures
Active Comparator
zipLine3 device verses conventional sutures
干预措施: conventional Suture (Device)
Zip3 Device
Active Comparator
干预措施: Zip3 (Device)
结局指标
主要结局
Wound healing
时间窗: 3-month
Wound healing as judged by the CVAS (Cosmetic Visual Analogue Scale) wound healing scale
次要结局
- time of procedure(immediately)
研究者
研究点 (3)
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