Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2026-02-26 @ 4:19 PM
Study NCT ID:
NCT03912467
Status:
COMPLETED
Last Update Posted:
2019-04-11
First Post:
2019-04-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevalence of Pressure Ulcers Among Critically Ill Patients and Factors Associated With Their Occurrence in the ICU
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003668', 'term': 'Pressure Ulcer'}], 'ancestors': [{'id': 'D012883', 'term': 'Skin Ulcer'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1228}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2017-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-10', 'studyFirstSubmitDate': '2019-04-08', 'studyFirstSubmitQcDate': '2019-04-10', 'lastUpdatePostDateStruct': {'date': '2019-04-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pressure Ulcer Presence on the study day', 'timeFrame': 'Through study completion, an average of 1 day', 'description': 'Presence (1) or absence (0) of pressure ulcer (however grade of pressure ulcer) during the study period which is a 1 Day Study Prevalence'}], 'secondaryOutcomes': [{'measure': 'Grade of Pressure Ulcer on the study day', 'timeFrame': 'Through study completion, an average of 1 day', 'description': 'Grade (from 1 to 4) of pressure ulcer during the study period which is a 1 Day Study Prevalence'}, {'measure': 'Area of Pressure Ulcer on the study day', 'timeFrame': 'Through study completion, an average of 1 day', 'description': "Area on the patient's body of pressure ulcer during the study period which is a 1 Day Study Prevalence"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pressure Ulcer', 'Critical Care', 'Intensive Care Unit Syndrome']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patient in Critical Care during study day.', 'eligibilityCriteria': "The inclusion criteria were :\n\n* hospitalization in the ICU\n* age ≥ 18 years.\n\nThe exclusion criterion was:\n\n\\- refusal to participate in the study by the patient or by the patient's family when the patient was unable to consent."}, 'identificationModule': {'nctId': 'NCT03912467', 'acronym': 'PRESSURE', 'briefTitle': 'Prevalence of Pressure Ulcers Among Critically Ill Patients and Factors Associated With Their Occurrence in the ICU', 'organization': {'class': 'OTHER', 'fullName': 'French Society for Intensive Care'}, 'officialTitle': 'Prevalence of Pressure Ulcers Among Critically Ill Patients and Factors Associated With Their Occurrence in the ICU', 'orgStudyIdInfo': {'id': 'PRESSURE'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Pressure Ulcer Evaluation', 'type': 'OTHER', 'description': 'Patient was evaluated according to presence of pressur ulcer or not'}]}, 'contactsLocationsModule': {'locations': [{'zip': '47923', 'city': 'Agen', 'country': 'France', 'facility': 'Hôpital Saint-Esprit', 'geoPoint': {'lat': 44.20199, 'lon': 0.62055}}, {'zip': '49000', 'city': 'Angers', 'country': 'France', 'facility': "CHU d'Angers", 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'zip': '92166', 'city': 'Antony', 'country': 'France', 'facility': "Hopital Privé d'Antony", 'geoPoint': {'lat': 48.75329, 'lon': 2.29668}}, {'zip': '57245', 'city': 'Ars-Laquenexy', 'country': 'France', 'facility': 'Hopital Mercy', 'geoPoint': {'lat': 49.09377, 'lon': 6.26989}}, {'zip': '90015', 'city': 'Belfort', 'country': 'France', 'facility': 'Hopital Nord Franche Comté', 'geoPoint': {'lat': 47.64218, 'lon': 6.85385}}, {'zip': '93000', 'city': 'Bobigny', 'country': 'France', 'facility': 'Hopital Avicenne', 'geoPoint': {'lat': 48.90982, 'lon': 2.45012}}, {'zip': '33000', 'city': 'Bordeaux', 'country': 'France', 'facility': 'CHU Pellegrin', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '33075', 'city': 'Bordeaux', 'country': 'France', 'facility': 'Hopital St-Andre', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '92100', 'city': 'Boulogne-Billancourt', 'country': 'France', 'facility': 'Hopital Ambroise Pare', 'geoPoint': {'lat': 48.83545, 'lon': 2.24128}}, {'zip': '29240', 'city': 'Brest', 'country': 'France', 'facility': 'HIA Clermont Tonnerre', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}, {'zip': '92140', 'city': 'Clamart', 'country': 'France', 'facility': 'Hopital Antoine Beclere', 'geoPoint': {'lat': 48.80299, 'lon': 2.26692}}, {'zip': '92190', 'city': 'Clamart', 'country': 'France', 'facility': 'HIA Percy', 'geoPoint': {'lat': 48.80299, 'lon': 2.26692}}, {'zip': '92700', 'city': 'Colombes', 'country': 'France', 'facility': 'Hopital Louis Mourier', 'geoPoint': {'lat': 48.91882, 'lon': 2.25404}}, {'zip': '91100', 'city': 'Corbeil-Essonnes', 'country': 'France', 'facility': 'Groupe Hospitalier Sud Ile de France', 'geoPoint': {'lat': 48.60603, 'lon': 2.48757}}, {'zip': '31700', 'city': 'Cornebarrieu', 'country': 'France', 'facility': 'Clinique des Cèdres', 'geoPoint': {'lat': 43.64967, 'lon': 1.32588}}, {'zip': '94010', 'city': 'Créteil', 'country': 'France', 'facility': 'CHU Henri Mondor', 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}, {'zip': '21709', 'city': 'Dijon', 'country': 'France', 'facility': 'CHU Dijon Bourgogne', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'zip': '95600', 'city': 'Eaubonne', 'country': 'France', 'facility': 'Hopital Simone Veil', 'geoPoint': {'lat': 48.99712, 'lon': 2.28249}}, {'zip': '92380', 'city': 'Garches', 'country': 'France', 'facility': 'Hopital Raymond Poincare', 'geoPoint': {'lat': 48.84226, 'lon': 2.18232}}, {'zip': '38700', 'city': 'Grenoble', 'country': 'France', 'facility': 'CHU Grenoble Alpes', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'zip': '77600', 'city': 'Jossigny', 'country': 'France', 'facility': "Grand Hopital de l'Est Francilien", 'geoPoint': {'lat': 48.83765, 'lon': 2.75432}}, {'zip': '97400', 'city': 'La Réunion', 'country': 'France', 'facility': 'CHU Réunion Saint Pierre', 'geoPoint': {'lat': 44.29707, 'lon': 0.11776}}, {'zip': '94270', 'city': 'Le Kremlin-Bicêtre', 'country': 'France', 'facility': 'CHU Kremlin-Bicetre', 'geoPoint': {'lat': 48.81471, 'lon': 2.36073}}, {'zip': '59037', 'city': 'Lille', 'country': 'France', 'facility': 'Hopital Roger Salengro', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '69003', 'city': 'Lyon', 'country': 'France', 'facility': 'HIA Desgenettes Lyon', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '69437', 'city': 'Lyon', 'country': 'France', 'facility': 'Groupe Hospitalier Edouard Herriot', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '78200', 'city': 'Mantes-la-Jolie', 'country': 'France', 'facility': 'Hopital Francois Quesnay', 'geoPoint': {'lat': 48.99048, 'lon': 1.7167}}, {'zip': '13003', 'city': 'Marseille', 'country': 'France', 'facility': 'Hopital Européen Marseille', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '13015', 'city': 'Marseille', 'country': 'France', 'facility': 'CHU Marseille Hopital Nord', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '13385', 'city': 'Marseille', 'country': 'France', 'facility': 'Hopital de la Timone', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '57038', 'city': 'Metz', 'country': 'France', 'facility': 'Hopital Notre-Dame de Bon Secours', 'geoPoint': {'lat': 49.11911, 'lon': 6.17269}}, {'zip': '93370', 'city': 'Montfermeil', 'country': 'France', 'facility': 'GHIRM', 'geoPoint': {'lat': 48.8982, 'lon': 2.57913}}, {'zip': '34090', 'city': 'Montpellier', 'country': 'France', 'facility': 'CHU Lapeyronie', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '54035', 'city': 'Nancy', 'country': 'France', 'facility': 'CHU Nancy', 'geoPoint': {'lat': 48.68439, 'lon': 6.18496}}, {'zip': '44000', 'city': 'Nantes', 'country': 'France', 'facility': 'CHU Nantes', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '44035', 'city': 'Nantes', 'country': 'France', 'facility': 'Hopital Laennec', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '06202', 'city': 'Nice', 'country': 'France', 'facility': "Hopital l'Archet", 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'zip': '30029', 'city': 'Nîmes', 'country': 'France', 'facility': 'CHU Nimes', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}, {'zip': '75010', 'city': 'Paris', 'country': 'France', 'facility': 'Hopital St Louis', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75012', 'city': 'Paris', 'country': 'France', 'facility': 'GH Diaconnesses Croix Saint Simon', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75013', 'city': 'Paris', 'country': 'France', 'facility': 'La Pitié Salpetriere', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75014', 'city': 'Paris', 'country': 'France', 'facility': 'Cochin', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75014', 'city': 'Paris', 'country': 'France', 'facility': 'Institut Mutualiste Montsouris', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75015', 'city': 'Paris', 'country': 'France', 'facility': 'CHU Necker Enfants Malades', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75015', 'city': 'Paris', 'country': 'France', 'facility': 'CHU Robert Debré', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75015', 'city': 'Paris', 'country': 'France', 'facility': 'HEGP', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75020', 'city': 'Paris', 'country': 'France', 'facility': 'Hopital Tenon', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '86021', 'city': 'Poitiers', 'country': 'France', 'facility': 'CHU Poitiers', 'geoPoint': {'lat': 46.58261, 'lon': 0.34348}}, {'zip': '91480', 'city': 'Quincy-sous-Sénart', 'country': 'France', 'facility': 'Hopital Privé Claude Galien', 'geoPoint': {'lat': 48.67294, 'lon': 2.53419}}, {'zip': '93200', 'city': 'Saint-Denis', 'country': 'France', 'facility': 'Hopital Delafontaine', 'geoPoint': {'lat': 48.93564, 'lon': 2.35387}}, {'zip': '31240', 'city': 'Saint-Jean', 'country': 'France', 'facility': "Clinique de l'Union", 'geoPoint': {'lat': 43.66519, 'lon': 1.50459}}, {'zip': '94160', 'city': 'Saint-Mandé', 'country': 'France', 'facility': 'HIA Béjin', 'geoPoint': {'lat': 48.83864, 'lon': 2.41579}}, {'zip': '34200', 'city': 'Sète', 'country': 'France', 'facility': 'Hopital Saint Clair', 'geoPoint': {'lat': 43.4028, 'lon': 3.69278}}, {'zip': '67200', 'city': 'Strasbourg', 'country': 'France', 'facility': 'CHU Strasbourg', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'zip': '31400', 'city': 'Toulouse', 'country': 'France', 'facility': 'CHU Toulouse Rangueil', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '93290', 'city': 'Tremblay-en-France', 'country': 'France', 'facility': 'Hopital Privé du Vert Galan', 'geoPoint': {'lat': 48.94956, 'lon': 2.5684}}, {'zip': '59322', 'city': 'Valenciennes', 'country': 'France', 'facility': 'Hopital Jean Bernard', 'geoPoint': {'lat': 50.35909, 'lon': 3.52506}}, {'zip': '94805', 'city': 'Villejuif', 'country': 'France', 'facility': 'Institut Gustave Roussy', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}, {'zip': '33140', 'city': "Villenave-d'Ornon", 'country': 'France', 'facility': 'HIA Robert Pique', 'geoPoint': {'lat': 44.77935, 'lon': -0.56707}}, {'zip': '91330', 'city': 'Yerres', 'country': 'France', 'facility': "Hopital Privé du Val d'Yerres", 'geoPoint': {'lat': 48.71785, 'lon': 2.49338}}], 'overallOfficials': [{'name': 'Gael Piton, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'French Intensive Care Society'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'French Society for Intensive Care', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}