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临床试验/NCT06616376
NCT06616376已完成不适用

The Affect Of An Anti-Embolism Stocking Protocol On The Development Of Early Venous Thromboembolia In Patients With Knee Artroplasty

Cukurova University2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2019年10月16日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
2
主要终点
Distribution of Descriptive Characteristics and Surgical Information of the Patients

研究概览

简要总结

This study was conducted to determine the effect of anti-embolism stocking (AES) use protocol affected the development of early venous thromboembolism (VTE) in patients undergoing total knee arthroplasty (TKA).

The randomized controlled single-blind intervention study included 40 patients (Experimental Group: 20, Control Group: 20) who underwent TKA surgery in a university hospital's Orthopedics and Traumatology clinic between 2019 and 2021. While the experimental group received the AES protocol one day before the operation and continued until the 10 th day after the operation, the control group received AES on the 0 th day after the operation and remained in the patient until the 21st day after the operation. In the study, a "Data Collection Form" with DVT and PE signs and symptoms was used.

详细描述

The study was carried out at a university hospital's Orthopedics and Traumatology clinic. Knee arthroplasty surgery is performed on an average of 85 patients per year in the hospital with a bed capacity of 1200. The Orthopedics and Traumatology clinic has 36 beds and 9 nurses on staff.

In the clinic, LMWH is given to patients who will have knee arthroplasty 12 hours before the procedure. Following knee arthroplasty, an elastic bandage is placed over the dressing on the operated extremity, and AES is only applied to the intact extremity. AES is dressed on both extremities after the elastic bandage is removed. Foot movements begin on the first postoperative day, and patients are mobilized on the first or second postoperative day. Patients are admitted to the clinic for a period of 5-7 days. LMWH application, which began in the preoperative period, continues in the postoperative period for approximately 21 days (until the sutures are removed). The AES usage protocol is not implemented in the clinic, and no training is provided to patients regarding the use of AES by healthcare personnel. After TKA surgery, AES patients are dressed, and it is recommended that they wear them without removing them for 21 days (sutures are removed).

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
Single (Participant)

盲法说明

To prevent patients undergoing TKA surgery from being affected by one another, the patients were hospitalized in separate rooms, and the orthopedic clinic team was made aware of the situation. The patients in the control group were told not to remove their socks until the sutures were removed after the operation, whereas the patients in the experimental group were told to remove their socks on the 10th day after the operation, so the patients had no idea which group they were in.

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Older than 18 years old,
  • No harm in wearing AES,
  • Patients who agreed to participate in the study.

排除标准

  • Bilateral TKA used patients,
  • Having excess leg edema, pulmonary edema, heart failure,
  • Having leg ischemia,
  • Having skin graft,
  • An open wound in the area where AES will be applied,
  • Having arterial and venous vessel disease,
  • Having neuropathy,
  • Having cellulite on the patient's leg to whom AES will be applied,
  • Having an infection such as fasciitis or panniculitis,
  • Those who declare that they will not use AES for ten days in accordance with the recommendations.

结局指标

主要结局

Distribution of Descriptive Characteristics and Surgical Information of the Patients

时间窗: Three weeks

The mean age of the experimental group was 68.6±7.1 years (range: 51-81 years) and the mean age of the control group was 68.5±8.8 years (range: 57-89 years). There was chronic disease in 90% of the experimental group, and the rate of chronic disease in the control group was 60%. Mobility status of the experimental group 1 day before the surgery; 65% (n:13) were independent, 15% (n:3) self-supported and 20% (n:4) needed help. Mobility status of the control group 1 day before the surgery; 60% (n:11) were independent, 40% (n:8) self-supported, and 5% (n:1) needed help. Mobility status of the experimental group after surgery; 10% (n:2) were independent, 90% (n:18) were self-sufficient. Mobility status in the control group; 20% (n:4) were independent, 75% (n:15) were self-sufficient and 5% (n:1) needed help. All patients in the experimental and control groups used low molecular weight heparin or anticoagulants before surgery.

VTE Evaluation Form

时间窗: Three weeks

It consists of 19 questions covering symptoms of VTE, DVT and PE.

次要结局

  • The Use of Anti Embolism Stocking Protocol(Two weeks)

研究者

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

Ismail Furkan Basıbuyuk

specialist nurse

Cukurova University

研究点 (2)

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