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临床试验/NCT05552599
NCT05552599已完成不适用

The Effect of Body Temperature Changes Durıng Total Knee Arthroplasty Surgery on The Formatıon of Early Postoperatıve Pressure Sore

Hitit University2 个研究点 分布在 1 个国家目标入组 122 人开始时间: 2018年3月3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
122
试验地点
2
主要终点
In collecting the data, three different data collection tools were used: "Personal Information Form"

研究概览

简要总结

This study aims to determine effect of body temperature changes during total knee arthroplasty surgery on early postoperative pressure sore formation.

详细描述

BACKGROUND: Intraoperative hypothermia for a prolonged period increases the risk of hospital-acquired pressure sores.

PURPOSE: This study aims to determine effect of body temperature changes during total knee arthroplasty surgery on early postoperative pressure sore formation.

METHODS: This experimental study was performed with experimental-control group (N=122) patients. Data were collected with "Personal Information Form", "Body and Ambient Temperature Record Form", "Braden Risk Assessment Scale". Experimental group participants were covered with a wool blanket, and control group was given standard care.

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 (Participant)

入排标准

年龄范围
20 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Aged 20-85 years
  • Hospitalized for at least four days and accepted to participate were included in the study.

排除标准

  • Under the age of 20 - over 85,
  • Pregnant and having comorbid diseases,
  • Spinal cord injuries,
  • Skin problems in areas where there is a risk of pressure loss,
  • Undergoing hemodialysis,
  • Having creatinine and serum albumin levels higher than 3 mg/dl,
  • Having immobility, incontinence, anemic, having malignant tumor(s),
  • BMI <19 or BMI >40,
  • Hemoglobin level below 10 g/dl,
  • Infection,
  • American Society of Anesthesiology (ASA) score of 3 or more,
  • Experiencing friction, tearing and shearing,
  • Undergoing more than one surgical intervention,
  • Having conditions requiring the use of non-normal anesthetic agents and sedation,
  • Using vasoconstrictive drugs,
  • Using positioning devices,
  • Undergoing prolonged surgical intervention,
  • Having arterial pressure lower than 32 mmHg,
  • Having diabetes mellitus requiring insulin therapy.

结局指标

主要结局

In collecting the data, three different data collection tools were used: "Personal Information Form"

时间窗: 12 months

The personal information form prepared by the researcher using the literature consisted of seven items in total, questioning age, gender, marital status, educational status, occupational status, income level and previous hospitalization experience.

Body and Ambient Temperature Record Form"

时间窗: 12 months

It is the form that allows to keep track of the temperature of the patient's room, the temperature of the patient's body before putting on the surgical gown, the temperature of the operating room, the body temperature before anesthesia, and the body temperature in the first, second and third hours following anesthesia.

"Braden Risk Assessment Scale".

时间窗: 12 months

Braden Risk Assessment Scale includes six sub-scales: sensory perception, moisture, activity, mobility, nutrition, friction and shear. The total score of the scale ranges between 6-23. A total score of 12 or lower shows high risk; 13-14 moderate risk; 15-16 low risk, and 15-18 considered mild risk for people over 75 years old. The scale includes six sub-scales: sensory perception, moisture, activity, mobility, nutrition, friction and shear. The sub-scales of sensory perception, moisture, activity, mobility and nutrition are scored 1-4; the friction-shear sub-scale 1-3, and the total score ranges between 6-23. The risk increases as the total score decreases. 15-18 points are accepted as low risk in people over 75 years old.

次要结局

未报告次要终点

研究者

发起方
Hitit University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Zehra UNAL

Principal Investigator

Hitit University

研究点 (2)

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