A Comparison of 2-octyl Cyanoacrylate Skin Adhesive and Polyester Mesh for Wound Closure in Total Knee Arthroplasty, A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Patient observer scar assessment score (POSAS)
研究概览
简要总结
The goal of this randomized controlled study is to investigate the Efficacy of Using skin adhesive (Dermabond) and skin adhesive with polyester mesh (Dermabond Prineo )for Wound Closure in Total Knee Arthroplasty, The main question it aim to answer
1 Are skin adhesive alone and with Polyester mesh in Total knee arthroplasty different in Patient satisfaction evaluated by POSAS score
详细描述
Nowadays, there are many methods of wound closure in Total Knee arthroplasty, such as nylon, skin staple, and sterile strip, which differ in advantages and disadvantages of each technique. However, these methods have the same disadvantages: wound discharge, which may lead to infection, wound separation, and the need for wound dressing. It is also a burden for patients and caregivers. In travelling to change the wound in a hospital, There are many costs in terms of wound dressing equipment, travel costs and time off from work for caregivers to take patients to get wound dressing.
Skin adhesive is an innovation for wound closure in total knee arthroplasty. It reduces the problem of wound separation, with no need for wound dressing.
Skin adhesive mesh has been studied in many studies, showing that it can be used well. Strong It is no different from traditional wound closure; the scar is more beautiful. Patients are more satisfied. But the disadvantage is the high price.
Skin adhesive without polyester mesh has the advantage of being cheaper three times than polyester mesh but less intense than with mesh. This makes it unpopular.
No studies have been found comparing wound dressings with mesh and no mesh After knee replacement surgery.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •OA knee need for Total knee arthroplasty
- •Age 50-80 years old
排除标准
- •Previous surgery of knee
- •History of Keloid, Scar, Psoriasis at the knee
- •History of contact dermatitis with skin adhesive
- •Cognitive impairment
结局指标
主要结局
Patient observer scar assessment score (POSAS)
时间窗: 6 weeks, 3 months
Evaluated Patient observer scar assessment score (POSAS) * The POSAS is composed of two numerical scales that evaluate signs and symptoms of healing. * Consists of the two following parts: a scale for patients and a scale for observers. * Both contain six items punctuated numerically from 1 to 10 * The lowest score is 1 and corresponds to the normal skin * The highest score is 10 and corresponds to the worst skin * The total score of both scales can be calculated simply by adding the scores of each of the six items. * The total score will range from 6 to 60.
次要结局
- Vancouver scar scale(6weeks, 3 months)
- Wound complication(Within 3 months)
- Wound drainage(2 weeks)
研究者
Pooriwat Lertsurawat
Resident Orthopedic of Hatyai Hospital
HatYai Hospital