A Prospective, Non Blinded, Randomized Controlled Post Market Study Designed to Compare the Use of the Zip Surgical Skin Closure Device vs. Conventional Steel Staples for Skin Closure in Subjects Who Undergo a bi Lateral Knee Arthroplasty
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Effectiveness Outcome - Wound Healing
研究概览
简要总结
Study designed to evaluate the Zip Surgical Skin Closure device versus conventional steel staple placement when utilized for surgical wound closure after bi lateral unicompartmental or bi later total knee replacement.
详细描述
This is a randomized, within patient control study aiming to enroll up to 25 subjects requiring bi lateral knee arthroplasty (unicompartmental or toal) at a single study center. Subjects will be followed for up for 6 weeks post surgery to evaluate wound healing and overall satisfaction of closure methods.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients requiring epidermal closure after bi lateral total or partial (unicompartmental) knee arthroplasty;
- •Patients willing to be evaluated at discharge and 6-weeks 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
Subjects randomized to receive one knee (left or right) closed with ZipSurgical Skin Closure and the other knee closed with standard staples
干预措施: Zip Surgical Skin Closure (Device)
Zip Surgical Skin Closure
Subjects randomized to receive one knee (left or right) closed with ZipSurgical Skin Closure and the other knee closed with standard staples
干预措施: Steel Staples (Device)
Steel Staples
Subjects randomized to receive one knee (left or right) closed with Staples and the other knee closed with ZipSurgical Skin Closure
干预措施: Zip Surgical Skin Closure (Device)
Steel Staples
Subjects randomized to receive one knee (left or right) closed with Staples and the other knee closed with ZipSurgical Skin Closure
干预措施: Steel Staples (Device)
结局指标
主要结局
Effectiveness Outcome - Wound Healing
时间窗: 6 weeks post surgery
Wound healing as judged by the Cosmetic Visual Analogue Scale - Photos taken at 6 weeks post surgery will be judged by panel of Plastic Surgeons blinded to the treatment assignments.
次要结局
- Patient Satisfaction of Scars(At 6 week Follow up (exit) visit)
- Patient Pain(Throughout 6 week study period (Discharge, 2 week follow up and 6 week follow up (exit) visits.))
- Surgeon Satisfaction with the Closure Method(At Discharge, 1-3 days post surgery)