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临床试验/NCT03190447
NCT03190447已完成不适用

Randomized Clinical Trial Comparing 5 Types Dressings in Wounds by Primary Orthopedic Surgery of Total Hip Arthroplasty and / or Knee

Corporacion Parc Tauli1 个研究点 分布在 1 个国家目标入组 560 人开始时间: 2017年4月20日最近更新:
适应症

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

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

发起方
Corporacion Parc Tauli
申办方类型
Other
责任方
Principal Investigator
主要研究者

Maria Lopez-Parra

RN MSU Bioethics MSU Education and ICT

Corporacion Parc Tauli

研究点 (1)

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