Comparison of Postoperative Wound Between Dermabond PRINEO™(2-octyl Cyanoacrylate Adhesive and Polyester Mesh) and Subcuticular Suture in Simultaneous Total Knee Arthroplasty
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- wound Hypertrophy scale at postoperative 6 month
研究概览
简要总结
This study aims to compare the clinical results of postoperative wound between Dermabond PRINEO™(2-octyl Cyanoacrylate adhesive and polyester mesh) and subcuticular suture in simultaneous total knee arthroplasty
There is previous studies over whether or not to use skin adhesive material is superior or inferior to subcuticular suture This study prospectively randomized patients receiving bilateral total knee arthroplasty(TKA). Patients preference and clinical results was investigated in both knee of same patients who received skin adhesive or subcuticular suture in each knee.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Double blind
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients for total knee arthroplasty
- •having medicare insurance
排除标准
- •Rheumatoid arthritis
- •Other inflammatory arthritis
- •Neuropsychiatric patients
- •Allergy or intolerance to study material
- •Patients with an American Society of Anesthesiologists(ASA) score of IV (angina, congestive heart failure, dementia, cerebrovascular accident)
结局指标
主要结局
wound Hypertrophy scale at postoperative 6 month
时间窗: at postoperative 6 months
Vancouver scar scale, patient and observer report scar assessment scale
次要结局
- wound complication(postoperative 6 month)
- Skin closure time(operation day)
- Stitch out time(postoperative 2 weeks)
- Stitch out visual visual analogue scale(VAS)(postoperative 2 weeks)
研究者
Yong In
Head of Orthopaedic Surgery
The Catholic University of Korea