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

Pressure Ulcer Clinical Trial

— PRESSURE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03912467
• Other study ID #: PRESSURE
• Status: Completed
• Start date: June 1, 2017
• Est. completion date: December 1, 2017

Study information

• Verified date: April 2019
• Source: French Society for Intensive Care
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1228
• Est. completion date: December 1, 2017
• Est. primary completion date: June 1, 2017
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Critical Care
• Critical Illness
• Intensive Care Unit Syndrome
• Pressure Ulcer
• Ulcer

Intervention

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

Locations

Country	Name	City	State
France	Hôpital Saint-Esprit	Agen
France	CHU d'Angers	Angers
France	Hopital Privé d'Antony	Antony
France	Hopital Mercy	Ars-Laquenexy
France	Hopital Nord Franche Comté	Belfort
France	Hopital Avicenne	Bobigny
France	CHU Pellegrin	Bordeaux
France	Hopital St-Andre	Bordeaux
France	Hopital Ambroise Pare	Boulogne Billancourt
France	HIA Clermont Tonnerre	Brest
France	HIA Percy	Clamart
France	Hopital Antoine Beclere	Clamart
France	Hopital Louis Mourier	Colombes
France	Groupe Hospitalier Sud Ile de France	Corbeil-Essonnes
France	Clinique des Cèdres	Cornebarrieu
France	CHU Henri Mondor	Creteil
France	CHU Dijon Bourgogne	Dijon
France	Hopital Simone Veil	Eaubonne
France	Hopital Raymond Poincare	Garches
France	CHU Grenoble Alpes	Grenoble
France	Grand Hopital de l'Est Francilien	Jossigny
France	CHU Réunion Saint Pierre	La Réunion
France	CHU Kremlin-Bicetre	Le Kremlin-Bicêtre
France	Hopital Roger Salengro	Lille
France	Groupe Hospitalier Edouard Herriot	Lyon
France	HIA Desgenettes Lyon	Lyon
France	Hopital Francois Quesnay	Mantes-la-Jolie
France	CHU Marseille Hopital Nord	Marseille
France	Hopital de la Timone	Marseille
France	Hopital Européen Marseille	Marseille
France	Hopital Notre-Dame de Bon Secours	Metz
France	GHIRM	Montfermeil
France	CHU Lapeyronie	Montpellier
France	CHU Nancy	Nancy
France	CHU Nantes	Nantes
France	Hopital Laennec	Nantes
France	Hopital l'Archet	Nice
France	CHU Nimes	Nîmes
France	CHU Necker Enfants Malades	Paris
France	CHU Robert Debré	Paris
France	Cochin	Paris
France	GH Diaconnesses Croix Saint Simon	Paris
France	HEGP	Paris
France	Hopital St Louis	Paris
France	Hopital Tenon	Paris
France	Institut Mutualiste Montsouris	Paris
France	La Pitié Salpetriere	Paris
France	CHU Poitiers	Poitiers
France	Hopital Privé Claude Galien	Quincy-sous-Sénart
France	Clinique de l'Union	Saint-Jean
France	Hopital Saint Clair	Sète
France	Hopital Delafontaine	St-Denis
France	HIA Béjin	St-Mande
France	CHU Strasbourg	Strasbourg
France	CHU Toulouse Rangueil	Toulouse
France	Hopital Privé du Vert Galan	Tremblay-en-France
France	Hopital Jean Bernard	Valenciennes
France	Institut Gustave Roussy	Villejuif
France	HIA Robert Pique	Villenave-d'Ornon
France	Hopital Privé du Val d'Yerres	Yerres

Sponsors (1)

Lead Sponsor	Collaborator
French Society for Intensive Care

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pressure Ulcer Presence on the study 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	Through study completion, an average of 1 day
Secondary	Grade of Pressure Ulcer on the study day	Grade (from 1 to 4) of pressure ulcer during the study period which is a 1 Day Study Prevalence	Through study completion, an average of 1 day
Secondary	Area of Pressure Ulcer on the study day	Area on the patient's body of pressure ulcer during the study period which is a 1 Day Study Prevalence	Through study completion, an average of 1 day