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CompletedNCT03912467PRESSUREUpdated Apr 11, 2019

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

An observational study in Pressure Ulcer, Critical Care and Intensive Care Unit Syndrome, sponsored by French Society for Intensive Care. Completed at 60 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-04-11.

Sponsored by French Society for Intensive Care · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
1,228
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Pressure Ulcer
  • Critical Care
  • Intensive Care Unit Syndrome
03

In context

Pressure Ulcer

518 studies on the registry are indexed under Pressure Ulcer; 117 are open to participants now.

This study's enrollment of 1,228 is above the median of 154 across 97 observational studies indexed under Pressure Ulcer.

Browse Pressure Ulcer studies →

Lead sponsor

French Society for Intensive Care is the lead sponsor of 13 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Patient in Critical Care during study day.

Eligibility 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.
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
1,228 participants (actual)
Patient registry
No

Interventions

  • OtherPressure Ulcer Evaluation

    Patient was evaluated according to presence of pressur ulcer or not

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Through study completion, an average of 1 day

Secondary outcomes

  1. 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

    Time frame: Through study completion, an average of 1 day

  2. 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

    Time frame: Through study completion, an average of 1 day

07

Study locations

60 sites
  • Hôpital Saint-Esprit
    Agen, 47923, France
  • CHU d'Angers
    Angers, 49000, France
  • Hopital Privé d'Antony
    Antony, 92166, France
  • Hopital Mercy
    Ars-Laquenexy, 57245, France
  • Hopital Nord Franche Comté
    Belfort, 90015, France
  • Hopital Avicenne
    Bobigny, 93000, France
  • CHU Pellegrin
    Bordeaux, 33000, France
  • Hopital St-Andre
    Bordeaux, 33075, France
  • Hopital Ambroise Pare
    Boulogne Billancourt, 92100, France
  • HIA Clermont Tonnerre
    Brest, 29240, France
  • Hopital Antoine Beclere
    Clamart, 92140, France
  • HIA Percy
    Clamart, 92190, France
  • Hopital Louis Mourier
    Colombes, 92700, France
  • Groupe Hospitalier Sud Ile de France
    Corbeil-Essonnes, 91100, France
  • Clinique des Cèdres
    Cornebarrieu, 31700, France
  • CHU Henri Mondor
    Creteil, 94010, France
  • CHU Dijon Bourgogne
    Dijon, 21709, France
  • Hopital Simone Veil
    Eaubonne, 95600, France
  • Hopital Raymond Poincare
    Garches, 92380, France
  • CHU Grenoble Alpes
    Grenoble, 38700, France
  • Grand Hopital de l'Est Francilien
    Jossigny, 77600, France
  • CHU Réunion Saint Pierre
    La Réunion, 97400, France
  • CHU Kremlin-Bicetre
    Le Kremlin-Bicêtre, 94270, France
  • Hopital Roger Salengro
    Lille, 59037, France
  • HIA Desgenettes Lyon
    Lyon, 69003, France
  • Groupe Hospitalier Edouard Herriot
    Lyon, 69437, France
  • Hopital Francois Quesnay
    Mantes-la-Jolie, 78200, France
  • Hopital Européen Marseille
    Marseille, 13003, France
  • CHU Marseille Hopital Nord
    Marseille, 13015, France
  • Hopital de la Timone
    Marseille, 13385, France
  • Hopital Notre-Dame de Bon Secours
    Metz, 57038, France
  • GHIRM
    Montfermeil, 93370, France
  • CHU Lapeyronie
    Montpellier, 34090, France
  • CHU Nancy
    Nancy, 54035, France
  • CHU Nantes
    Nantes, 44000, France
  • Hopital Laennec
    Nantes, 44035, France
  • Hopital l'Archet
    Nice, 06202, France
  • CHU Nimes
    Nîmes, 30029, France
  • Hopital St Louis
    Paris, 75010, France
  • GH Diaconnesses Croix Saint Simon
    Paris, 75012, France
  • La Pitié Salpetriere
    Paris, 75013, France
  • Cochin
    Paris, 75014, France
  • Institut Mutualiste Montsouris
    Paris, 75014, France
  • CHU Necker Enfants Malades
    Paris, 75015, France
  • CHU Robert Debré
    Paris, 75015, France
  • HEGP
    Paris, 75015, France
  • Hopital Tenon
    Paris, 75020, France
  • CHU Poitiers
    Poitiers, 86021, France
  • Hopital Privé Claude Galien
    Quincy-sous-Sénart, 91480, France
  • Clinique de l'Union
    Saint-Jean, 31240, France
  • Hopital Delafontaine
    St-Denis, 93200, France
  • HIA Béjin
    St-Mande, 94160, France
  • CHU Strasbourg
    Strasbourg, 67200, France
  • Hopital Saint Clair
    Sète, 34200, France
  • CHU Toulouse Rangueil
    Toulouse, 31400, France
  • Hopital Privé du Vert Galan
    Tremblay-en-France, 93290, France
  • Hopital Jean Bernard
    Valenciennes, 59322, France
  • Institut Gustave Roussy
    Villejuif, 94805, France
  • HIA Robert Pique
    Villenave-d'Ornon, 33140, France
  • Hopital Privé du Val d'Yerres
    Yerres, 91330, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 11, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03912467
Lead sponsor
French Society for Intensive Care
Responsible party
Sponsor
First posted
Apr 11, 2019
Start date
Jun 1, 2017
Primary completion
Jun 1, 2017
Completion
Dec 1, 2017
Last update
Apr 11, 2019

Study contacts

Gael Piton, MD, PhD
study chair · French Intensive Care Society

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.

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