NCT03912467

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,228

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2017

Shorter than P25 for all trials

Geographic Reach
1 country

60 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2017

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

April 8, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 11, 2019

Completed
Last Updated

April 11, 2019

Status Verified

April 1, 2019

Enrollment Period

Same day

First QC Date

April 8, 2019

Last Update Submit

April 10, 2019

Conditions

Outcome Measures

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

    Through study completion, an average of 1 day

Secondary Outcomes (2)

  • Grade of Pressure Ulcer on the study day

    Through study completion, an average of 1 day

  • Area of Pressure Ulcer on the study day

    Through study completion, an average of 1 day

Interventions

Patient was evaluated according to presence of pressur ulcer or not

Eligibility Criteria

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

Patient in Critical Care during study day.

You may qualify if:

  • hospitalization in the ICU
  • age ≥ 18 years.
  • \- refusal to participate in the study by the patient or by the patient's family when the patient was unable to consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (60)

Hôpital Saint-Esprit

Agen, 47923, France

Location

CHU d'Angers

Angers, 49000, France

Location

Hopital Privé d'Antony

Antony, 92166, France

Location

Hopital Mercy

Ars-Laquenexy, 57245, France

Location

Hopital Nord Franche Comté

Belfort, 90015, France

Location

Hopital Avicenne

Bobigny, 93000, France

Location

CHU Pellegrin

Bordeaux, 33000, France

Location

Hopital St-Andre

Bordeaux, 33075, France

Location

Hopital Ambroise Pare

Boulogne-Billancourt, 92100, France

Location

HIA Clermont Tonnerre

Brest, 29240, France

Location

Hopital Antoine Beclere

Clamart, 92140, France

Location

HIA Percy

Clamart, 92190, France

Location

Hopital Louis Mourier

Colombes, 92700, France

Location

Groupe Hospitalier Sud Ile de France

Corbeil-Essonnes, 91100, France

Location

Clinique des Cèdres

Cornebarrieu, 31700, France

Location

CHU Henri Mondor

Créteil, 94010, France

Location

CHU Dijon Bourgogne

Dijon, 21709, France

Location

Hopital Simone Veil

Eaubonne, 95600, France

Location

Hopital Raymond Poincare

Garches, 92380, France

Location

CHU Grenoble Alpes

Grenoble, 38700, France

Location

Grand Hopital de l'Est Francilien

Jossigny, 77600, France

Location

CHU Réunion Saint Pierre

La Réunion, 97400, France

Location

CHU Kremlin-Bicetre

Le Kremlin-Bicêtre, 94270, France

Location

Hopital Roger Salengro

Lille, 59037, France

Location

HIA Desgenettes Lyon

Lyon, 69003, France

Location

Groupe Hospitalier Edouard Herriot

Lyon, 69437, France

Location

Hopital Francois Quesnay

Mantes-la-Jolie, 78200, France

Location

Hopital Européen Marseille

Marseille, 13003, France

Location

CHU Marseille Hopital Nord

Marseille, 13015, France

Location

Hopital de la Timone

Marseille, 13385, France

Location

Hopital Notre-Dame de Bon Secours

Metz, 57038, France

Location

GHIRM

Montfermeil, 93370, France

Location

CHU Lapeyronie

Montpellier, 34090, France

Location

CHU Nancy

Nancy, 54035, France

Location

CHU Nantes

Nantes, 44000, France

Location

Hopital Laennec

Nantes, 44035, France

Location

Hopital l'Archet

Nice, 06202, France

Location

CHU Nimes

Nîmes, 30029, France

Location

Hopital St Louis

Paris, 75010, France

Location

GH Diaconnesses Croix Saint Simon

Paris, 75012, France

Location

La Pitié Salpetriere

Paris, 75013, France

Location

Cochin

Paris, 75014, France

Location

Institut Mutualiste Montsouris

Paris, 75014, France

Location

CHU Necker Enfants Malades

Paris, 75015, France

Location

CHU Robert Debré

Paris, 75015, France

Location

HEGP

Paris, 75015, France

Location

Hopital Tenon

Paris, 75020, France

Location

CHU Poitiers

Poitiers, 86021, France

Location

Hopital Privé Claude Galien

Quincy-sous-Sénart, 91480, France

Location

Hopital Delafontaine

Saint-Denis, 93200, France

Location

Clinique de l'Union

Saint-Jean, 31240, France

Location

HIA Béjin

Saint-Mandé, 94160, France

Location

Hopital Saint Clair

Sète, 34200, France

Location

CHU Strasbourg

Strasbourg, 67200, France

Location

CHU Toulouse Rangueil

Toulouse, 31400, France

Location

Hopital Privé du Vert Galan

Tremblay-en-France, 93290, France

Location

Hopital Jean Bernard

Valenciennes, 59322, France

Location

Institut Gustave Roussy

Villejuif, 94805, France

Location

HIA Robert Pique

Villenave-d'Ornon, 33140, France

Location

Hopital Privé du Val d'Yerres

Yerres, 91330, France

Location

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin UlcerSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Gael Piton, MD, PhD

    French Intensive Care Society

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 8, 2019

First Posted

April 11, 2019

Study Start

June 1, 2017

Primary Completion

June 1, 2017

Study Completion

December 1, 2017

Last Updated

April 11, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations