Body Temperature Changes and Early Postoperatıve Pressure Sore

Sponsor
Hitit University (Other)
Overall Status
Completed
CT.gov ID
NCT05552599
Collaborator
(none)
122
2
2
12
61
5.1

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: woolen blanket
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
122 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Prevention
Official Title:
The Effect of Body Temperature Changes Durıng Total Knee Arthroplasty Surgery on The Formatıon of Early Postoperatıve Pressure Sore
Actual Study Start Date :
Mar 3, 2018
Actual Primary Completion Date :
Mar 3, 2019
Actual Study Completion Date :
Mar 3, 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hitit University Çorum Turkey
2 HititU Çorum Turkey

Sponsors and Collaborators

  • Hitit University

Investigators

  • Principal Investigator: Zehra UNAL, zehra86_sevgi@hotmail.com

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Zehra UNAL, Principal Investigator, Hitit University
ClinicalTrials.gov Identifier:
NCT05552599
Other Study ID Numbers:
  • HititZ
First Posted:
Sep 23, 2022
Last Update Posted:
Sep 26, 2022
Last Verified:
Sep 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 26, 2022