Body Temperature Changes and Early Postoperatıve Pressure Sore

The Effect of Body Temperature Changes Durıng Total Knee Arthroplasty Surgery on The Formatıon of 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.

Study Overview

• Status: Completed
• Conditions: Hypothermia; Orthopedic Disorder; Nursing Caries; Pressure Sore
• Intervention / Treatment: Procedure: woolen blanket

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 122
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Çorum, Turkey
    • Hitit university
  • Çorum, Turkey
    • HititU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: woolen blanket; Preoperative pressure sore risk was assessed with the Braden Risk Assessment Scale. The patient's room temperature was recorded on the day of surgery before the patient was admitted for the operation. Body temperature was measured before the patient wore surgical gown. Before leaving the room, patient's body was covered with a woolen blanket. The temperature of the operating room was recorded. Body temperature was stabilized under normothermic conditions with a woolen blanket until the operation began. Body temperature was measured before anesthesia was given. Body temperature was measured in the 1st, 2nd and 3rd hour after anesthesia was given. The patient was evaluated with the Braden Risk Assessment Scale on the first, second and third postoperative days.	Procedure: woolen blanket; Woolen blanket: The people in the experimental group were treated with a standard hospital woolen.
No Intervention: standard of care; Preoperative pressure sore risk was assessed with the Braden Risk Assessment Scale. The patient's room temperature was recorded on the day of surgery before the patient was taken to the operation. Body temperature was measured before the patient wore surgical clothes. The temperature of the operating room was recorded. Body temperature was measured before anesthesia was givenBody temperature was measured at the 1st, 2nd and 3rd hour after anesthesia was given. The patient was evaluated with the Braden Risk Assessment Scale on the first, second and third postoperative days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
"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

Collaborators and Investigators

• Sponsor: Hitit University
• Investigators: Principal Investigator: Zehra UNAL, zehra86_sevgi@hotmail.com

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2018
• Primary Completion (Actual): March 3, 2019
• Study Completion (Actual): March 3, 2019

Study Registration Dates

• First Submitted: July 4, 2022
• First Submitted That Met QC Criteria: September 20, 2022
• First Posted (Actual): September 23, 2022

Study Record Updates

• Last Update Posted (Actual): September 26, 2022
• Last Update Submitted That Met QC Criteria: September 23, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Ulcer; Musculoskeletal Diseases; Hypothermia; Pressure Ulcer; Body Temperature Changes
• Other Study ID Numbers: HititZ

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No