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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05795777
Other study ID # 0000-0001-8907-0651
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 1, 2019
Est. completion date March 1, 2021

Study information

Verified date March 2023
Source Kocaeli University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 176
Est. completion date March 1, 2021
Est. primary completion date February 1, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 92 Years
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - hospitalization time not exceeding 24 hours

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Turkey Kocaeli Healt and Tecnology University Kocaeli Adana

Sponsors (1)

Lead Sponsor Collaborator
Kocaeli University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
15 minutes
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