Pressure UlcersIGS-2-MIRNCT07732517
Simplified Acute Physiology Score 2 and Pressure Ulcer Prediction in ICU.
An observational study of Pressure Ulcers, run by University Hospital, Bordeaux at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pressure Ulcers
- What is being tested?
- Pressure ulcer
- How many people
- 500 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2027to Sep 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Adults ≥ 18 years of age;
- Patients admitted to intensive care unit;
- Patients without any preexisting pressure ulcer on admission;
- Capacity to give informed consent.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Renaud PREVEL, Dr contact
France1 site
Hôpital Pellegrin
Bordeaux, 33000
Julie GAUTHIER, 05 56 79 56 79 ext. +33, julie.gauthier@chu-bordeaux.fr
About this study
Official title: Using the Simplified Acute Physiology Score 2 (SAPS 2) for Predicting Pressure Ulcer Formation Among Critically Ill Patients Admitted in Medical Intensive Care Unit.
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.
- Conditions
- Pressure Ulcers
- Being tested
- Pressure ulcer
- Keywords
- SAPS 2, Pressure ulcers, predictive test, Intensive Care Unit
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pressure ulcerOther
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
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to 20 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2026
- Study startFeb 2027 (estimated)
- Primary completionSep 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pressure UlcersStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07732517
- Sponsor's protocol ID
- CHUBX 2022/35
- Acronym
- IGS-2-MIR
- Status last verified
- Sep 2026
- First submitted
- 23 Jul 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using the Simplified Acute Physiology Score 2 (SAPS 2) for Predicting Pressure Ulcer Formation Among Critically Ill Patients Admitted in Medical Intensive Care Unit.
- ClinicalTrials.gov ID
- NCT07732517
- Acronym / sponsor ID
- IGS-2-MIR / CHUBX 2022/35
- Conditions
- Pressure Ulcers
- Keywords
- SAPS 2, Pressure ulcers, predictive test, Intensive Care Unit
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- Feb 2027 (estimated)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 29 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- Adults ≥ 18 years of age;
- Patients admitted to intensive care unit;
- Patients without any preexisting pressure ulcer on admission;
- Capacity to give informed consent.
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pressure ulcerSkin 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 | Other | – |
Primary outcome
Determine prognostic ability of the SAPS 2 in ICU patients
Time frame: From enrollment to 20 days
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
Related trials for Pressure Ulcers
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Not yet recruiting
Pulsed High Intensity Laser Versus Negative Pressure Therapy On Neuropathic Ulcers
Neuropathic Ulcers
Recruiting
Efficacy and Safety of ZKARE® Gel and Its Accessory ZKAPI® in the Treatment of Chronic Ulcers.
Chronic Ulcers
Not yet recruiting
The Effectiveness of a Caregiver-Based Multicomponent Intervention to Prevent Pressure Ulcers in Home-Cared-For Individuals With Dementia
Dementia, Home Care for Elderly or Disabled Individuals
Not yet recruitingObservational study
Hypertrophic Scar Prosthetic Pressure in Burn Amputee
Amputation Stump, Burn Injury
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Renaud PREVEL, Dr contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pressure Ulcers, run by University Hospital, Bordeaux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Julie GAUTHIER (05 56 79 56 79 ext. +33, julie.gauthier@chu-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine prognostic ability of the SAPS 2 in ICU patients (time frame: From enrollment to 20 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.