NCT05795777

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
176

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2019

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2021

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

March 9, 2023

Completed
25 days until next milestone

First Posted

Study publicly available on registry

April 3, 2023

Completed
Last Updated

April 3, 2023

Status Verified

March 1, 2023

Enrollment Period

1.3 years

First QC Date

March 9, 2023

Last Update Submit

March 21, 2023

Conditions

Keywords

Intensive Care UnitPressure UlcerRisk FactorsPrevalence

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age18 Years - 92 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients hospitalized in 3rd level intensive care units

You may qualify if:

  • 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

You may not qualify if:

  • hospitalization time not exceeding 24 hours

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kocaeli Healt and Tecnology University

Kocaeli, Adana, 41275, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin UlcerSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Refiye Akpolat

    Kocaeli Healt and Tecnology University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Proffesor

Study Record Dates

First Submitted

March 9, 2023

First Posted

April 3, 2023

Study Start

November 1, 2019

Primary Completion

February 1, 2021

Study Completion

March 1, 2021

Last Updated

April 3, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations