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Completed

NCT Number: NCT05552599

Body Temperature Changes and Early Postoperatıve Pressure Sore

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

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Key information

Conditions

Pressure Sore Body Temperature Changes Hypothermia Musculoskeletal Diseases Nursing Caries Orthopedic Disorder Pathological Conditions, Signs and Symptoms Pressure Ulcer Signs and Symptoms Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases

Age range

20 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hitit University, Çorum, Turkey (Türkiye)

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

woolen blanket

Procedure

Woolen blanket: The people in the experimental group were treated with a standard hospital woolen.

Primary outcomes

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

    Time frame: 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.

  2. Body and Ambient Temperature Record Form"

    Time frame: 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.

  3. "Braden Risk Assessment Scale".

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Hitit University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Sep 23, 2022
Registry last updated
Sep 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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