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Prevalence of Pressure Ulcers Among Critically Ill Patients and Factors Associated With Their Occurrence in the ICU (PRESSURE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03912467
Recruitment Status : Completed
First Posted : April 11, 2019
Last Update Posted : April 11, 2019
Sponsor:
Information provided by (Responsible Party):
French Society for Intensive Care

Brief Summary:
The prevalence of and risk factors for pressure ulcers (PUs) in critically ill patients have been poorly studied. The main objective of this study was to describe the prevalence of PUs in critically ill patients. Secondary objectives were to describe PUs, means of prevention of PUs, and factors associated with occurrence of PUs in the ICU.

Condition or disease Intervention/treatment
Pressure Ulcer Critical Care Intensive Care Unit Syndrome Other: Pressure Ulcer Evaluation

Detailed Description:
Pressure ulcers (PUs) among hospitalized patients are associated with a poor prognosis and with a high cost of care. Hospitalization in the ICU is a context where there is a high risk of occurrence of PUs, prevention of which is a priority for ICU teams caring for critically ill patients. However, the literature is inconclusive regarding the prevalence of PUs among critically ill patients and the associated risk factors. The main objective of this study was to describe the prevalence of PUs among critically ill patients hospitalized in the ICU. Secondary objectives were to describe means of prevention of PUs in the ICU and the characteristics of PUs, and to identify factors either related to the ICU or patient characteristics associated with occurrence of PUs in the ICU.

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Study Type : Observational
Actual Enrollment : 1228 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Prevalence of Pressure Ulcers Among Critically Ill Patients and Factors Associated With Their Occurrence in the ICU
Actual Study Start Date : June 1, 2017
Actual Primary Completion Date : June 1, 2017
Actual Study Completion Date : December 1, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pressure Sores


Intervention Details:
  • Other: Pressure Ulcer Evaluation
    Patient was evaluated according to presence of pressur ulcer or not


Primary Outcome Measures :
  1. Pressure Ulcer Presence on the study day [ Time Frame: Through study completion, an average of 1 day ]
    Presence (1) or absence (0) of pressure ulcer (however grade of pressure ulcer) during the study period which is a 1 Day Study Prevalence


Secondary Outcome Measures :
  1. Grade of Pressure Ulcer on the study day [ Time Frame: Through study completion, an average of 1 day ]
    Grade (from 1 to 4) of pressure ulcer during the study period which is a 1 Day Study Prevalence

  2. Area of Pressure Ulcer on the study day [ Time Frame: Through study completion, an average of 1 day ]
    Area on the patient's body of pressure ulcer during the study period which is a 1 Day Study Prevalence



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Patient in Critical Care during study day.
Criteria

The inclusion criteria were :

  • hospitalization in the ICU
  • age ≥ 18 years.

The exclusion criterion was:

- refusal to participate in the study by the patient or by the patient's family when the patient was unable to consent.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03912467


Locations
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Sponsors and Collaborators
French Society for Intensive Care
Investigators
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Study Chair: Gael Piton, MD, PhD French Intensive Care Society

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Responsible Party: French Society for Intensive Care
ClinicalTrials.gov Identifier: NCT03912467    
Other Study ID Numbers: PRESSURE
First Posted: April 11, 2019    Key Record Dates
Last Update Posted: April 11, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pressure Ulcer
Ulcer
Pathologic Processes
Skin Ulcer
Skin Diseases