跳至主要内容
临床试验/NCT04346875
NCT04346875Unknown不适用

Is the Number of Dressing Changes Associated With Acute PJI Following Total Joint Arthroplasty? A Randomized Clinical Trial

Bezmialem Vakif University0 个研究点目标入组 842 人开始时间: 2020年5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
842
主要终点
Periprosthetic infection rate

研究概览

简要总结

The primary aim of the study is to compare two methods for a relationship with total knee infection: regular changing of dressings and not changing dressings.

详细描述

Periprosthetic joint infection (PJI) is one of the most dreaded complications that occur after total joint arthroplasty. Periprosthetic joint infection remains an uncommon yet devastating complication that continues to influence the outcome of total joint arthroplasty. (1-4) Although different dressing methods have been described, the effect of changing the frequency of conventional dressings on PJI is curious.

After obtaining informed consent from all participants, parallel-group randomization will be performed with the help of a computer. The first dressing of all participants will be done in the operating room using the same materials. No drains will be used in any patient.

Then, according to the randomization, the procedures will be adjusted by the wound care nurse with the patient. All on-study and outcome data will be collected by the study staff blinded to study group assignment. The dressing group participants will be dressed by the same wound care nurse during the discharge. The dressing group participants will be dressed by the same wound care nurse in an outpatient service every three days using the same material. The total dressing number will be in the dressing group participant 5 times. Both group participants will be evaluated in the outpatient service after 2 weeks. Subsequently, all participants will be invited to check-in at the end of each month. All participants will be evaluated according to MSIS criteria in terms of superficial and deep periprosthetic infection.

The primary endpoint is to detect the difference between the incidence of periprosthetic infection after the regular dressing change and the incidence of the dressing unchanged group. In the secondary endpoint, it is to determine whether dressing change is an independent factor with multiple logistic regression test.

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
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Participants who agreed to inclusion in the study

排除标准

  • •Missing follow-up
  • •Participants with insufficient data

研究组 & 干预措施

Non-changing group

Active Comparator

Participants will not be subject to dressing change.

干预措施: No application (Procedure)

Regularly changing group

Experimental

Participants will undergo dressing every 3 days by the senior wound care nurse

干预措施: Regularly changing of dressing (Procedure)

结局指标

主要结局

Periprosthetic infection rate

时间窗: 90 days

Incidence of patients to be diagnosed with periprosthetic infection according to MSIS criteria.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Orkhan Aliyev

Residents Doctor in Orthopedics Department

Bezmialem Vakif University

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