Body Temperature Changes and Early Postoperatıve Pressure Sore

NCT ID: NCT05552599

Last Updated: 2022-09-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

122 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-03

Study Completion Date

2019-03-03

Brief Summary

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

Detailed Description

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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.

Conditions

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Pressure Sore Orthopedic Disorder Hypothermia Nursing Caries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

woolen blanket

Intervention Type PROCEDURE

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

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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woolen blanket

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hitit University

OTHER

Sponsor Role lead

Responsible Party

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Zehra UNAL

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zehra UNAL

Role: PRINCIPAL_INVESTIGATOR

[email protected]

Locations

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Hitit University

Çorum, , Turkey (Türkiye)

Site Status

HititU

Çorum, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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HititZ

Identifier Type: -

Identifier Source: org_study_id

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