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Not yet recruitingNCT07732517IGS-2-MIRUpdated Sep 9, 2026

Simplified Acute Physiology Score 2 and Pressure Ulcer Prediction in ICU.

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

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
500
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Pressure Ulcers

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Keywords

  • SAPS 2
  • Pressure ulcers
  • predictive test
  • Intensive Care Unit
03

In context

Pressure Ulcer

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 →

Lead sponsor

University Hospital, Bordeaux is the lead sponsor of 806 studies on the registry; 197 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
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Adults ≥ 18 years of age;
  • Patients admitted to intensive care unit;
  • Patients without any preexisting pressure ulcer on admission;
  • Capacity to give .

Exclusion criteria

Exclusion Criteria:

  • Length of stay less than 24 hours;
  • Decline to participate in the study;
  • Admission criteria being post-surgery monitoring and/or admission for drug intoxication
  • Patients admitted to ICU with a pre-existent sacral pressure ulcer (any stage).
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

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.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
500 participants (estimated)
Patient registry
No

Interventions

  • OtherPressure ulcer

    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

06

What researchers measure

Primary outcomes

  1. 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

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Study locations

1 site
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

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.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 23, 2026
First posted
Jul 29, 2026
StartEst.
Feb 2027
Primary completionEst.
Sep 2028
CompletionEst.
Sep 2028
Last update
Sep 9, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07732517
Responsible party
Sponsor
First posted
Jul 29, 2026
Start date
Feb 2027 (estimated)
Primary completion
Sep 2028 (estimated)
Completion
Sep 2028 (estimated)
Last update
Sep 9, 2026

Study contacts

Julie GAUTHIER
Contact
julie.gauthier@chu-bordeaux.fr
05 56 79 56 79 ext. +33
Renaud PREVEL, Dr
Contact
renaud.prevel@cu-bordeaux.fr

Oversight

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

Not currently enrolling

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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