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临床试验/NCT04422119
NCT04422119Unknown不适用

Standard Dressing Versus Moist Dressing in the Course of the Postoperative Wound in Patients With Knee Prosthesis

Germans Trias i Pujol Hospital1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2018年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
150
试验地点
1
主要终点
Change in number of dressing changes

研究概览

简要总结

The aim of the study is: to evaluate the efficacy of two post-operative dressings in the management of the surgical wounds in patients who received a knee prosthesis

详细描述

This was a randomised, controlled, clinical trial on patients who received a primary knee prosthesis in 2018-2019. Treatment group was given a multi-layer foam dressing with Safetac. The control group received standard treatment with povidone-iodine and a gauze dressing with plaster. 50 patients was needed for sufficient power. Primary outcome measures were; the characteristics of the surgical wound, patient reported comfort and adaptability according to the physiotherapist. Secondary outcome measures were: the clinical status and quality of life level according to the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Statistical analysis was performed by using IBM SPSS version 25, with a statistical significance of 5%.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
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

  • •Surgical intervention of total primary knee prosthesis
  • •Informed consent approved and signed by participants.

排除标准

  • •Sensitivity or allergy to study dressings

研究组 & 干预措施

Multi-layer foam dressing

Experimental

Patients in experimental group will receive the application of a multi-layer foam dressing with Safetac in surgical wound

干预措施: Multi-Foam dressing (Procedure)

Usual care

Active Comparator

Patients in control group will receive standard treatment with povidone-iodine and a gauze dressing with plaster.

干预措施: Usual care (Procedure)

结局指标

主要结局

Change in number of dressing changes

时间窗: From fist day post-surgery to 7th postoperative day

Number of dressing applications to the patients required

次要结局

  • Change in patient comfort(From fist day post-surgery to 7th postoperative day)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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