Multiples Facilities
Multiple Locations, France
NCT Number: NCT06465225
The aim of the study is to determine the clinical value of using a powered alternating pressure air overlay mattress (P-APAM) in the prevention of pressure injury (PI) in patients at medium to high risk.
This study is noncomparative, observational study.
Patients older than 18 years of age, with a medium to high risk of PI, without PI, up during the day, and lying between 15 and 20 hours per day on a specific P-APAM will be included. The study will be conducted in nursing homes, and in long-stay geriatrics department.
Patients will be followed up for 35 days. The use of the P-APAM is associated with the usual PI prevention measures. The primary outcome is the percentage of patients who will develop at least one PI of at least stage 2 on the sacrum, spine, or heel between day 0 and day 35 . Secondary endpoints are patient assessments of comfort, caregiver satisfaction, mattress noise level, and mattress safety.
Looking for future studies?
Notify Me18 year and older
All sexes
Observational
Multiple Locations, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A) One or more of the following phenotypic criteria:
Significant unintentional weight loss: A weight loss of ≥ 5% within 1 month or ≥ 10% within 6 months Low Body Mass Index (BMI): BMI < 18.5 kg/m² for individuals under 70 years old, BMI < 21 kg/m² for individuals aged 70 years and older Reduced Muscle Mass Evident reduction in muscle mass AND
B) One of the following etiological criteria:
Inadequate nutritional intake:
Nutritional intake less than 50% of the energy requirements for more than one week Reduced food intake for more than two weeks Presence of Disease or Stress Metabolism Acute or chronic illness, or any condition causing metabolic stress that increases energy requirements
Patients with a medium to high risk of developing pressure injury, without pressure injury, up during the day and lying between 15 and 20 hours per day will ly a on a R'GO Soins overlay mattress
Time frame: 35 days after installation on the mattress (at day 35)
Percentage of patients who developed at least one stage 2 PI of the sacrum, backbone, or heel (areas of support when lying down)
Time frame: 35 days after installation on the mattress (at day 35)
Time frame: 35 days after installation on the mattress (at day 35)
On a scale from 0 (not satisfied at all) to 4 (very satisfied)
Time frame: 35 days after installation on the mattress (at day 35)
On a scale from 0 (not satisfied at all) to 4 (very satisfied)
Time frame: 35 days after installation on the mattress (at day 35)
On a scale from 1 (constantly moist) to 4 (rarely moist)
Time frame: At day 35
By collecting any adverse event or mattress malfunction during the follow up
Nausicaa Medical
Industry
Prevention of Pressure Ulcers in Patients at Medium to High Risk of Pressure Ulcers Using the R'GO SOINS Overlay Mattress : Observational Study
Acronym: PRESERVE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06294327
Decubitus Ulcer, Pressure Injury
Sint-Niklaas, East Flanders, Belgium
View Trial DetailsNCT07255937
Arterial Leg Ulcer, Burns
Madrid, Spain
View Trial DetailsNCT07586748
Cardiovascular Diseases, Embolism and Thrombosis
View Trial DetailsNCT03522714
Pathologic Processes, Pathological Conditions, Signs and Symptoms
Chicago, Illinois, United States
View Trial Details