Evaluation of a Novel Sutureless Drain Securement Device (K-Lock Device) and Comparison to Standard Suture-based Drain Securement Techniques
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Time it Takes to Secure and Dress Each Drain in Totality
研究概览
简要总结
The purpose of this study is to evaluate an investigational sutureless drain securement device (K-Lock) and compare this device to standard drain securement.
详细描述
This study will evaluate the feasibility, safety and efficacy of a novel sutureless drain securement device (K-Lock) via direct comparison to suture-based techniques. In this study the sutureless drain securement device will be compared to the use of sutures to secure drains. Patients will be randomized to either A) left side K-Lock with right side suture-based technique or B) right side K-Lock with left side suture-based technique.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- 是
入选标准
- •Age 18 or older
- •Patient of the Department of Plastic and Reconstructive Surgery
- •Able to sign English language Consent form
- •Undergoing any of the following procedures requiring placement of 2 or more drains (preferably bilateral) including: Breast reconstruction, Bilateral Breast Reduction, Abdominoplasty, Body Contour surgery (e.g. panniculectomy, brachiplasty, thighplasty)
排除标准
- •Patients with unilateral drain placement
- •Unable to sign English language consent form
- •Allergy to Tegaderm Dressing
研究组 & 干预措施
A K-Lock left
A) left side K-Lock with right side suture-based technique
干预措施: K-Lock (Device)
B K-Lock right
B) right side K-Lock with left side suture-based technique.
干预措施: K-Lock (Device)
结局指标
主要结局
Time it Takes to Secure and Dress Each Drain in Totality
时间窗: Day of Surgery
Time it takes to secure and dress each drain will be evaluated in totality by evaluation of video recordings to record timestamps and documented on "K-Lock Study Outcomes" tool. This will help determine the feasibility of using this device.
次要结局
- Ease of Use(Day of Surgery)
- Skin Injury(On Average Day 10)