Randomized Clinical Trial Comparing 5 Types Dressings in Wounds by Primary Orthopedic Surgery of Total Hip Arthroplasty and / or Knee
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 560
- 试验地点
- 1
- 主要终点
- Skin integrity
研究概览
简要总结
Surgical wounds are covered to prevent bleeding, absorb the exudates and provide a barrier against external contamination. Currently, in Corporació PT after orthopedic surgery, traditional occlusive dressing of sterile gauze and non-woven hypoallergenic adhesive tape is placed. In many cases the appearance of blistering caused by the use of these conventional dressings is observed, which increases the risk of infection, pain and the final cost of the procedure. There are other types of dressings that could improve these aspects but comparative data are not currently available. Main objective: to identify the dressing that better preserves the integrity of the skin.
Design: Prospective randomized comparative study of 5 types of dressings used in total knee and hip arthroplasty surgical wounds (TKA and THA).
Secondary Objectives: To identify the dressing that provides greater advantages and minor inconveniences in TKA and THA surgery.
Study population: Patients older than 18 years undergoing fast track primary TKA or THA. 110 patients
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- 否
入选标准
- •Patients older than 18 years
- •operated on primary TKA and THA in the fast track circuit
- •adequate cognitive ability.
排除标准
- •damaged skin
- •no self-care capacity or caregiver
- •inadequate cognitive ability to consent freely
- •patients who will not undergo "fast track" surgery
结局指标
主要结局
Skin integrity
时间窗: 2 weeks after surgery
Skin integrity is a composite endpoint including absence of any of the following items: blisters, erosion, erythema, maceration, swelling, wound dehiscence, purulent exudate) in the area of the surgical wound, measured by wound inspection
次要结局
未报告次要终点
研究者
Maria Lopez-Parra
RN MSU Bioethics MSU Education and ICT
Corporacion Parc Tauli
