Pressure SoreNCT05552599
Body Temperature Changes and Early Postoperatıve Pressure Sore
A study testing woolen blanket in people with Pressure Sore and Orthopedic Disorder, run by Hitit University at 2 sites in Turkey (Türkiye).
Trial summary
This study aims to determine effect of body temperature changes during total knee arthroplasty surgery on early postoperative pressure sore formation. Read more about this study
- Who is it for?
- Ages 20 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Pressure Sore, Orthopedic Disorder, Hypothermia
- What is being tested?
- woolen blanket
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 3 Mar 2018to 3 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 20-85 years
- Hospitalized for at least four days and accepted to participate were included in the study.
Who cannot join
- 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,
Show all 19Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Pressure Sore, Orthopedic Disorder, Hypothermia, Nursing Caries
- Being tested
- woolen blanket
- Medical subject headings
- Pressure Ulcer, Musculoskeletal Diseases, Hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
woolen blanketProcedure or surgery
Woolen blanket: The people in the experimental group were treated with a standard hospital woolen.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2022
- Study start3 Mar 2018
- Primary completion3 Mar 2019
- Study completion3 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pressure SoreStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hitit University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zehra UNAL, Hitit University
- Investigators
- Zehra UNAL, Principal investigator, zehra86_sevgi@hotmail.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05552599
- Sponsor's protocol ID
- HititZ
- Status last verified
- Sep 2022
- First submitted
- 4 Jul 2022
- Last updated
- 26 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Body Temperature Changes Durıng Total Knee Arthroplasty Surgery on The Formatıon of Early Postoperatıve Pressure Sore
- ClinicalTrials.gov ID
- NCT05552599
- Acronym / sponsor ID
- HititZ
- Conditions
- Pressure Sore, Orthopedic Disorder, Hypothermia, Nursing Caries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Hitit UniversityUniversity, hospital or other
- Study start
- 3 Mar 2018 (actual)
- Primary completion
- 3 Mar 2019 (actual)
- Study completion
- 3 Mar 2019 (actual)
- First posted
- 23 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| woolen blanket | Experimental | Procedure: woolen blanketPreoperative 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. |
| 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. |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Aged 20-85 years
- Hospitalized for at least four days and accepted to participate were included in the study.
Key exclusion criteria (19 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| woolen blanketWoolen blanket: The people in the experimental group were treated with a standard hospital woolen. | Procedure or surgery | woolen blanket |
Primary outcome
In collecting the data, three different data collection tools were used: "Personal Information Form"
Time frame: 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.
Body and Ambient Temperature Record Form"
Time frame: 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.
"Braden Risk Assessment Scale".
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2022.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zehra UNAL principal investigator
zehra86_sevgi@hotmail.com
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing woolen blanket in people with Pressure Sore and Orthopedic Disorder, run by Hitit University at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In collecting the data, three different data collection tools were used: "Personal Information Form" (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2022.