Comparison of Knotless Barbed Suture and Standard Suture in Knee Replacement Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,000
- 主要终点
- Number of soft tissue infections
研究概览
简要总结
Barbed suture use has been gaining increased acceptance and has been reported to offer potential advantages in wound closure of hip and knee replacement surgeries.
The goal of this study is to compare joint replacement patient outcomes who receive a knotless barbed suture versus a traditional suture (randomized into two arms). The traditional suture used at our joint replacement program is defined as: interrupted sutures to close the retinaculum followed by running monocryl sutures for skin closure. Both knotless barbed suture and the traditional sutures have similar suture size.
Patient outcomes examined will be patient range of motion (recorded daily) and complications with wound healing (evaluated periodically in-person at post-operative visits).
Secondary outcomes examined will include wound drainage on dressings by surface area and weight, as well as the wound cosmesis and perceived presence of subcutaneous surgical knots.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •primary joint replacement
排除标准
- •no prior joint surgery
- •no infection
结局指标
主要结局
Number of soft tissue infections
时间窗: 12 weeks
evaluation of wound infection after surgery, number of patients with wound infection based on clinical examination
use of antibiotics to treat infection, recorded by number
时间窗: 12 weeks
record whether antibiotics used for suspicion or treatment of superficial infection, number of episodes recorded
measurement of incision drainage, measured in grams and mm surface area
时间窗: 2 weeks
evaluation of incision drainage based on dressing saturation size and weight, measured in grams for weight, and measured by surface area mm
assessment of quality of incision closure, recorded by time and number
时间窗: 12 weeks
record delayed healing and reported by time, suture rejection based on number of episodes
次要结局
未报告次要终点
研究者
Alexander Sah, MD
Physician and Research Chair, Institute for Joint Restoration and Research
Washington Hospital Healthcare System