An observational study in Pressure Ulcers, sponsored by University Hospital, Bordeaux. Not yet recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-09.
Sponsored by University Hospital, Bordeaux · Observational
Critically ill patients admitted in intensive care units are at high risk of developing pressure ulcer (also known as pressure injury). In Bordeaux teaching hospital, a prevalence survey identified the department of anaesthesia and Intensive Care Unit with the highest rate for pressure ulcer (up to 29% of patients). Yet, developing a PU will increase patient's pain, health expenses, and the risks for further complications such as infection, prolonged hospitalization and a higher mortality rate. Therefore, this study aims at improving pressure ulcer prediction by using the Simplified Acute Physiology Score 2 (SAPS 2) as the latter estimates the severity of a patient condition while factoring in several causative factors for pressure ulcer among ICU patients. This could then lead to a better use and allocation of human and material resources and improve patients' care.
Pressure ulcers are soft tissue lesions induced when an unrelieved pressure, from a prominent bone, is applied on the skin and the underlying tissues, leading to ischemia and eventually necrosis of the area. Commonly, pressure ulcers are often located at the sacrum and heels. Yet, developing rapidly, they burden patients' illness and hospital care and costs: an increase in the length of stay of 11.2 days and additional costs of € 5,612 per patient in 2012. Although pressure ulcers are a common issue for hospitalized patients (12.5%) in France according to the SRLF, the prevalence rate is greatly higher in Intensive Care Units (30%) due to several factors inherent to the type of critically ill patients admitted: severity of the initial condition, age, weight, altered perfusion/oxygenation ratio, and length of stay.
Currently, nurse staff at medical ICU Bordeaux teaching hospital are using the Braden scale as the gold standard to predict the risk for pressure ulcer formation. Despite its high sensitivity (more than 80% of critically ill adult patients are identified at high risk), this scale is well known to have a low specificity which makes its use suboptimal. This scale does not indeed process ICU-specific predictive factors for pressure ulcer risk. Some of these factors, as aforementioned, are integrated into the Simplified Acute Physiology Score 2, which assesses the severity of patients upon admission and is systematically and mandatorily collected by medical teams. Studies show that 35% of patients with a SAPS 2 ≥ 33 have pressure ulcers, compared to 17% of patients with a SAPS 2 ≤ 33, and that the risk of developing a pressure ulcer increases in conjunction with SAPS 2. Thus, the SAPS-2 could be useful for identifying patients at risk of developing pressure ulcers in ICU.
Nurse staff at medical ICU Bordeaux teaching hospital therefore propose to evaluate the contribution of using the SAPS 2 (IGS-2) in addition to the Braden scale, to improve the prediction of the risk of sacral pressure ulcers, in adult patients hospitalized in medical intensive care, in order to better target patients to be treated and for a more effective and efficient use of human and material resources. We design a prospective observational cohort study, for a duration of 19 months, in which adult patients admitted in the Pellegrin medical intensive care unit will be considered for inclusion (first day) following inclusion and non-inclusion criteria. All included patients will be free of pressure ulcers upon admission. The scores studied in the project (Braden and SAPS 2/IGS-2) are measured beforehand and therefore without knowledge of the development of pressure ulcers. The prediction horizon used is 20 days, which corresponds to the maximum expected length of stay for the majority of patients in the target population.
545 studies on the registry are indexed under Pressure Ulcer; 129 are open to participants now.
This study's planned enrollment of 500 is above the median of 138 across 110 observational studies indexed under Pressure Ulcer.
Browse Pressure Ulcer studies →University Hospital, Bordeaux is the lead sponsor of 806 studies on the registry; 197 are open to participants now.
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This is a single-centre, prospective, observational cohort study with a prognostic focus, involving patients admitted to the medical intensive care unit at Pellegrin.
500 subjects will be included in the study. Of these, 90 per cent are expected to have a Braden score of ≤12 (patients at risk of pressure ulcers), i.e. 450 patients.
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Exclusion Criteria:
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Skin monitoring, assessment of the Braden Score, calculation of the Simplified Acute Physiology Score 2 (SAP2), dating the appearance of a sacred wound and determining its classification
Determine prognostic ability of the SAPS 2 in ICU patients
The primary outcome is to determine the prognostic ability (sensitivity, specificity, positive predictive value, and negative predictive value) of the SAPS 2 in ICU patients classified as at risk of pressure ulcer according to the Braden Scale: * Test to be evaluated: The SAPS 2 obtained on admission. * Reference test: The occurrence or absence of stage I pressure ulcer using the EPUAP/NPIAP classification through direct observation between days 1 and 20. For participants discharged from the ICU within 20 days, the presence or absence of a sacral pressure ulcer at discharge will be used as the final status for the analysis.
Time frame: From enrollment to 20 days
Start is estimated for Feb 2027; primary completion for Sep 2028, 19 months later.
Of 49 observational studies under Pressure Ulcer, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 141. This study's planned 19 months is below that.
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This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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University Hospital, Bordeaux →