Body Temperature Changes and Early Postoperatıve Pressure Sore

NCT05552599 | Completed

• 1 other identifier: HititZ
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Pressure Sore; Orthopedic Disorder; Hypothermia; Nursing Caries

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

woolen blanket

EXPERIMENTAL

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

standard of care

NO INTERVENTION

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.

Interventions

woolen blanket PROCEDURE

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

woolen blanket

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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,

Sponsors & Collaborators

• Hitit University: lead

Study Sites (2)

Hitit University

Çorum, Turkey (Türkiye)

Location

HititU

Çorum, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pressure Ulcer; Musculoskeletal Diseases; Hypothermia

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Zehra UNAL

  zehra86_sevgi@hotmail.com

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 4, 2022
• First Posted: September 23, 2022
• Study Start: March 3, 2018
• Primary Completion: March 3, 2019
• Study Completion: March 3, 2019
• Last Updated: September 26, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

TU (2)