Body Temperature Changes and Early Postoperatıve Pressure Sore

Hypothermia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05552599
• Other study ID #: HititZ
• Status: Completed
• Phase: N/A
• Start date: March 3, 2018
• Est. completion date: March 3, 2019

Study information

• Verified date: September 2022
• Source: Hitit University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: March 3, 2019
• Est. primary completion date: March 3, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Body Temperature Changes
• Hypothermia
• Musculoskeletal Diseases
• Nursing Caries
• Orthopedic Disorder
• Pressure Sore
• Pressure Ulcer

Intervention

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

Locations

Country	Name	City	State
Turkey	Hitit University	Çorum
Turkey	HititU	Çorum

Sponsors (1)

Lead Sponsor	Collaborator
Hitit University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	In collecting the data, three different data collection tools were used: "Personal Information Form"	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.	12 months
Primary	Body and Ambient Temperature Record Form"	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.	12 months
Primary	"Braden Risk Assessment Scale".	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.	12 months