Back to resultsBody Temperature Changes and Early Postoperatıve Pressure Sore
Primary Purpose
Pressure Sore, Orthopedic Disorder, Hypothermia
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
woolen blanket
Sponsored by
About this trial
This is an interventional prevention trial for Pressure Sore
Eligibility Criteria
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.
Sites / Locations
- Hitit University
- HititU
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
woolen blanket
standard of care
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
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.
"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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05552599
Brief Title
Body Temperature Changes and Early Postoperatıve Pressure Sore
Official Title
The Effect of Body Temperature Changes Durıng Total Knee Arthroplasty Surgery on The Formatıon of Early Postoperatıve Pressure Sore
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
March 3, 2018 (Actual)
Primary Completion Date
March 3, 2019 (Actual)
Study Completion Date
March 3, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hitit University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study aims to determine effect of body temperature changes during total knee arthroplasty surgery on early postoperative pressure sore formation.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pressure Sore, Orthopedic Disorder, Hypothermia, Nursing Caries
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
122 (Actual)
8. Arms, Groups, and Interventions
Arm Title
woolen blanket
Arm Type
Experimental
Arm Description
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.
Arm Title
standard of care
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
woolen blanket
Intervention Description
Woolen blanket: The people in the experimental group were treated with a standard hospital woolen.
Primary Outcome Measure Information:
Title
In collecting the data, three different data collection tools were used: "Personal Information Form"
Description
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.
Time Frame
12 months
Title
Body and Ambient Temperature Record Form"
Description
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.
Time Frame
12 months
Title
"Braden Risk Assessment Scale".
Description
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.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zehra UNAL
Organizational Affiliation
zehra86_sevgi@hotmail.com
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hitit University
City
Çorum
Country
Turkey
Facility Name
HititU
City
Çorum
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Body Temperature Changes and Early Postoperatıve Pressure Sore
We'll reach out to this number within 24 hrs