Pressure UlcerNCT05795777
Examination of the Pressure Ulcers in Intensive Care Patients.
An observational study of Pressure Ulcer and İntensive Care, run by Kocaeli University at 1 site in Turkey (Türkiye).
Trial summary
A pressure sore was localized skin and/or subcutaneous tissue injury, usually caused by pressure alone or a combination of shear and pressure, at bony prominences. Pressure sores, which are an indicator of the quality of health care, increase mortality, morbidity and cost. Read more about this study
- Who is it for?
- Ages 18 to 92 yearsHealthy volunteers can take part
- Conditions the study is for
- Pressure Ulcer, İntensive Care, Nurse's Role
- How many people
- 176 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2019to 1 Mar 2021
- Phase
- Observational
- 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 18 to 92 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients hospitalized in 3rd level intensive care units
Who may be able to join
- over 18 years old
- Hospitalized in the 3rd step intensive care unit
- Being hospitalized for at least 24 hours
- No pressure ulcers on the first hospitalization
Who cannot join
- hospitalization time not exceeding 24 hours
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kocaeli Healt and Tecnology University
Kocaeli, Adana, 41275
About this study
Official title: The Frequency of Pressure Ulcers In 3rd Level Intensive Care Unıts And Determinatıon of Affectıng Risk Factors
A pressure sore was localized skin and/or subcutaneous tissue injury, usually caused by pressure alone or a combination of shear and pressure, at bony prominences. Pressure sores, which are an indicator of the quality of health care, increase mortality, morbidity and cost. Pressure ulcers are the most common problem in intensive care patients and should be prevented. In the literature, the incidence of pressure ulcers in intensive care patients is between 1-59.9%.
A pressure sore is a localized injury to the skin and/or underlying soft tissue, usually over a bony prominence or associated with medical or other devices. This injury occurs when intense and/or prolonged pressure or pressure is accompanied by shear. Soft tissue tolerance to pressure and shear; temperature and humidity can affect nutrition, perfusion, concomitant conditions, and condition of soft tissue.
Read more
This study was carried out to determine the prevalence of pressure ulcers and influencing factors in patients hospitalized in the 3rd level intensive care unit of a university hospital.
Design: It is a descriptive, prospective, observational type study. Materials and Methods: The sample of the study consisted of 176 patients aged 18 years and above, 24 hours after hospitalization in the intensive care units of a University Hospital. Patient Information Form and Braden Scale for Predicting Pressure Ulcer Risk, Glasgow Coma Scale were used to collecting data. Statistical Package in statistical analysis for the social sciences 20.0 program was used.
Read the detailed description
Due to the renovation initiated in the intensive care units, the work was started in November 2019, but the working time was extended due to the Covid 19 pandemic that developed immediately after. The sample of the study consisted of patients who met the inclusion criteria and accepted participation, among the patients who were hospitalized on Wednesday, which was determined as the middle of each week, between November 2019 and February 2021 in the 3rd-level intensive care units of a university hospital.
Data Collection: "Personal Information Form" prepared by the researcher as a result of the literature review for data collection, "Braden Scale for Predicting Pressure Ulcer Risk" for evaluating pressure ulcers, "Glasgow Coma Score" for evaluating patient's consciousness status, and ulcer used by National Pressure Ulcer Advisory Panel and European Pressure Ulcer Advisory Panel staging classification was used.
- Conditions
- Pressure Ulcer, İntensive Care, Nurse's Role
- Keywords
- Intensive Care Unit, Pressure Ulcer, Risk Factors, Prevalence
- Medical subject headings
- Pressure Ulcer
What is being measured
The primary outcome is the main question the study is designed to answer.
Data collection from patients
The sample of the study consisted of patients who were hospitalized in the tertiary intensive care unit of a university hospital between November 2019 and February 2021, who met the inclusion criteria and accepted to participate in the study. Data were collected from patients every Wednesday, which was determined as the middle of the week. Patients were evaluated with the Braden Scale for Predicting Pressure Ulcer Risk. The total score of the scale varies between 6-23 points. As the scores obtained from the scale decrease, the risk of developing pressure ulcers increases. A scale score of 9 or less indicates a high risk, and a scale score of 19-23 indicates no risk.
Data collection from each patient took 15 minutes.
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2023
- Study start1 Nov 2019
- Primary completion1 Feb 2021
- Study completion1 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pressure UlcerStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 176 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kocaeli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Refiye Akpolat, Kocaeli University
- Investigators
- Refiye Akpolat, Principal investigator, Kocaeli Healt and Tecnology University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05795777
- Sponsor's protocol ID
- 0000-0001-8907-0651
- Status last verified
- Mar 2023
- First submitted
- 9 Mar 2023
- Last updated
- 3 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Frequency of Pressure Ulcers In 3rd Level Intensive Care Unıts And Determinatıon of Affectıng Risk Factors
- ClinicalTrials.gov ID
- NCT05795777
- Acronym / sponsor ID
- 0000-0001-8907-0651
- Conditions
- Pressure Ulcer, İntensive Care, Nurse's Role
- Keywords
- Intensive Care Unit, Pressure Ulcer, Risk Factors, Prevalence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 176 participants (actual)
- Lead sponsor
- Kocaeli UniversityUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 1 Feb 2021 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 3 Apr 2023 (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.
A pressure sore was localized skin and/or subcutaneous tissue injury, usually caused by pressure alone or a combination of shear and pressure, at bony prominences. Pressure sores, which are an indicator of the quality of health care, increase mortality, morbidity and cost. Pressure ulcers are the most common problem in intensive care patients and should be prevented. In the literature, the incidence of pressure ulcers in intensive care patients is between 1-59.9%.
A pressure sore is a localized injury to the skin and/or underlying soft tissue, usually over a bony prominence or associated with medical or other devices. This injury occurs when intense and/or prolonged pressure or pressure is accompanied by shear. Soft tissue tolerance to pressure and shear; temperature and humidity can affect nutrition, perfusion, concomitant conditions, and condition of soft tissue.
This study was carried out to determine the prevalence of pressure ulcers and influencing factors in patients hospitalized in the 3rd level intensive care unit of a university hospital.
Design: It is a descriptive, prospective, observational type study. Materials and Methods: The sample of the study consisted of 176 patients aged 18 years and above, 24 hours after hospitalization in the intensive care units of a University Hospital. Patient Information Form and Braden Scale for Predicting Pressure Ulcer Risk, Glasgow Coma Scale were used to collecting data. Statistical Package in statistical analysis for the social sciences 20.0 program was used.
Detailed description
Due to the renovation initiated in the intensive care units, the work was started in November 2019, but the working time was extended due to the Covid 19 pandemic that developed immediately after. The sample of the study consisted of patients who met the inclusion criteria and accepted participation, among the patients who were hospitalized on Wednesday, which was determined as the middle of each week, between November 2019 and February 2021 in the 3rd-level intensive care units of a university hospital.
Data Collection: "Personal Information Form" prepared by the researcher as a result of the literature review for data collection, "Braden Scale for Predicting Pressure Ulcer Risk" for evaluating pressure ulcers, "Glasgow Coma Score" for evaluating patient's consciousness status, and ulcer used by National Pressure Ulcer Advisory Panel and European Pressure Ulcer Advisory Panel staging classification was used.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 92 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients hospitalized in 3rd level intensive care units
Key inclusion criteria (4 listed)
- over 18 years old
- Hospitalized in the 3rd step intensive care unit
- Being hospitalized for at least 24 hours
- No pressure ulcers on the first hospitalization
Key exclusion criteria (1 listed)
- hospitalization time not exceeding 24 hours
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Data collection from patients
Time frame: 15 minutes
The sample of the study consisted of patients who were hospitalized in the tertiary intensive care unit of a university hospital between November 2019 and February 2021, who met the inclusion criteria and accepted to participate in the study. Data were collected from patients every Wednesday, which was determined as the middle of the week. Patients were evaluated with the Braden Scale for Predicting Pressure Ulcer Risk. The total score of the scale varies between 6-23 points. As the scores obtained from the scale decrease, the risk of developing pressure ulcers increases. A scale score of 9 or less indicates a high risk, and a scale score of 19-23 indicates no risk. Data collection from each patient took 15 minutes.
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 3 Apr 2023.
- Individual participant dataSharing planned: No
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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.
Refiye Akpolat principal investigator
Kocaeli Healt and Tecnology University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pressure Ulcer and İntensive Care, run by Kocaeli University at 1 site 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 4 inclusion and 1 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 3 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Data collection from patients (time frame: 15 minutes). 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 3 Apr 2023.