Wound Closure After Total Knee Replacement: Comparison Between Staples and Sutures.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 211
- 试验地点
- 2
- 主要终点
- Wound healing
研究概览
简要总结
To compare the wound healing after total knee replacement wound closure with staples versus subcuticular prolene suture.
详细描述
.Informed consent will be taken from all the patients who meet the inclusion and exclusion criteria and then will be randomized into one of the two study arms (Arm 1: will undergo wound closure with staples and Arm 2 wound closure with subcuticular prolene suture).
before the start of surgery. The primary investigator will open the sealed envelopes provided by the Indus Hospital Research Center's Clinical Research Unit (CRU) that provides the study arm allocation. The envelopes will follow the SNOSE protocol i.e. they will be sequentially numbered, opaque sealed envelopes. Before opening the envelope, the primary investigator will write the patient's medical record number, date and will sign the envelope. The envelope will contain carbon paper which will transfer the data allocation paper inside.
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
- None
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients undergoing primary total knee replacements for osteoarthritis or post-traumatic arthritis (diagnosed on X-rays and history)
- •Bilateral knee surgeries
- •Patients giving informed consent
排除标准
- •Patients having previous skin, neuromuscular or connective tissue disorder (confirmed by history)
- •Patients taking steroids (confirmed by history)
- •Body mass index > 30 (increases chances of wound dehiscence)
- •Lack of consent
- •Pregnant females (confirmed by history)
结局指标
主要结局
Wound healing
时间窗: Surgery till 1 year post-op
Wound healing will be assessed using Hollander Score
Complications
时间窗: Surgery till 1 year post-op
次要结局
未报告次要终点