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临床试验/NCT05158322
NCT05158322已完成不适用

Effectiveness of the Staphylococcus Aureus Decolonization Circuit in Reducing Infection at the Surgical Site in Patients Scheduled for Primary Arthroplasty in the Lower Limb

Corporacion Parc Tauli1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2021年10月14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
90
试验地点
1
主要终点
Evaluate with a VAS scale (0-10) the satisfaction of the participant with the information on the decolonization process of S. aureus.

研究概览

简要总结

Lower limb joint replacement surgery is one of the most prevalent globally. In our center, more than 400 lower limb arthroplasties (LLA) are performed annually. Developing a Surgical Site Infection (SSI) after (LLA) increases morbidity, mortality and healthcare costs. Staphylococcus aureus is the main causative agent of SSI and especially in LLA. One third of the population is a nasal carrier of Staphylococcus aureus, being a risk factor for patients who have to undergo knee replacement or hip replacement. Several studies have confirmed that the detection of S. aureus carriers and their subsequent decolonization reduces SSI rates

详细描述

Implementation of a screening of all patients who have to undergo lower limb arthroplasty in our center, decolonization of patients with a positive screening result for S. aureus and subsequent follow-up.The circuit is established in the following phases:

  1. Preoperative Nurse Visit:

Oral and written information on the study and procedure is given, the informed consent will be signed, and the sample (nasal swab) is collected from all patients scheduled for lower limb arthroplasty surgery in our center. The sample is sent to microbiology.

It will be recorded in the computerized medical history. 2. Control of results:

If the sample has been run by rapid circuit at 24 hours or conventional at 4 days, the Consultation Nurse reviews the results of the screened patients.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

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

  • •Over 18 years old
  • •Patients who are going to undergo knee or hip replacement surgery.
  • •Patients with a positive result in the first nasal smear to S. aureus, and follow the decolonization protocol.
  • •Patients who give their informed consent to participate in the study.

排除标准

  • •Patients scheduled for VPE less than 2 days after surgery.
  • •Patients unable to give their informed consent freely. Inadequate cognitive ability

结局指标

主要结局

Evaluate with a VAS scale (0-10) the satisfaction of the participant with the information on the decolonization process of S. aureus.

时间窗: 6 weeks

The participant is satisfied with the information received throughout the decolonization. to be assessed with the EVA scale (0 not at all satisfied / 10 very satisfied)

次要结局

  • The participant evaluates his social well-being on the VAS scale (0-10) based on the care received by professionals throughout the S. aureus decolonization process. The number of patients who scored 9 or 10 on the VAS scale will be assessed as satisfied.(6 weeks)

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

Francisco Zamora Carmona

Enfermero Práctica Avanzada

Corporacion Parc Tauli

研究点 (1)

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