A Prospective, Randomized Controlled Post-market Study to Compare the Use of the Zip® Surgical Skin Closure Device Versus Conventional Staples for Skin Closure in Subjects Having Undergone Bilateral Knee Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Incision Appearance / Scar Cosmesis
研究概览
简要总结
Study designed to compare the Zip Surgical Skin Closure device vs. conventional staples for wound closure following bi lateral knee replacement surgery.
详细描述
Prospective, randomized, within patient control study comparing the use of Zip Surgical Skin Closure device versus conventional staple placement when utilized for surgical wound closure after bi lateral unicompartmental or bi lateral total knee replacement. A total of up to 25 patients will be enrolled and followed for up to 8 weeks post surgery to evaluate wound healing and overall satisfaction of closure method.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients 18 years of age and older
- •Patients requiring epidermal closure after bi lateral total or partial (unicompartmental) knee arthroplasty
- •Patients willing to be evaluated at discharge, 2 weeks, and at the 6 to 8 week post op
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 patient unsuitable for this study
研究组 & 干预措施
Zip Surgical Skin Closure
Subject will be randomized to receive one knee (right or left) closed with Zip Surgical Skin Closure and the other knee closed with steel staples.
干预措施: Zip Surgical Skin Closure (Device)
Steel Staples
Subject will be randomized to receive one knee (right or left) closed with steel staples and the other knee closed with Zip Surgical Skin Closure.
干预措施: Steel Staples (Device)
结局指标
主要结局
Incision Appearance / Scar Cosmesis
时间窗: 6-8 weeks post surgery
Patient Scar Rating (0=Best to 10=Worst). A lower score means better scar rating. Surgeon Scar Rating (0=Best to 10=Worst). A lower score means better scar rating. Independent Plastic Surgeon Scar Rating by 8 week post op photos. (0=Best to 10=Worst). A lower score means better scar rating.
次要结局
- Surgeon Closure Method Satisfaction(6-8 weeks post op)
- Patient Pain - Incisional and General(Throughout 8 week study period (Discharge, 2 wk follow up and 8 wk exit visit))
- Surgeon and Patient Scar Satisfaction(6 to 8 wk follow up visit)
- Range of Motion(2 weeks and 6-8 weeks)