Clinical trial NCT05458050: An Investigation to Identify Subjects Admitted to Hospital With an Increased Risk of Developing Pressure Ulcers
Official title: A Double-blind, Intervention, Post-marketing Investigation to Identify Subjects Who Are Admitted to Hospital With an Increased Risk of Developing Pressure Ulcers, Using PU Sensor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pressure Ulcer
Lead sponsor: PU sensor AB
Sponsor class: INDUSTRY
Collaborators: name: Aurevia
First posted: 2022-07-14
Enrollment: 433
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Double blind
Primary purpose: PREVENTION

Brief summary: A double blind, non randomized, multicenter investigation

Detailed description: The study consists of 2 evaluations/visits.

Evaluation/visit 1: Takes place in connection with admission to the hospital. Informed consent, inclusion and exclusion criteria are assessed as well as assessment of skin type and inspection of the entire body skin. Pregnancy test on women of childbearing potential, height, weight, blood pressure and body temperature are measured. Questions about demography, health conditions, previous illnesses, nicotine habits. Risk assessment for pressure ulcers (Modified Norton or RAPS-scale) is carried out according to the hospital usual routine. Examination with PU sensor will be performed.

Evaluation/visit 2: Takes place in connection with the discharge from the hospital or 4 weeks after visit 1 if the research subject is still hospitalized. Full body skin inspection to see possible onset of pressure ulcers. Review of the research subject's medical records as well as review of nursing notes from the hospital where the research subject has been discharged from, to find any notes about pressure ulcers. The study participation is then terminated for the research subject.

Eligibility criteria: Inclusion Criteria:

1. Given their written consent to participate in the study
2. Male or female between ≥18 years and ≤ 64 years with a reduced mobility, where the hospitalization may involve a risk that the person may become less active or Male or female ≥65 years

Exclusion Criteria:

1. Existing pressure ulcer or damage to the skin around the sacrum where the PU sensor plate and pillow are to be placed
2. Fever ≥38 ºC, within 30 minutes before the examination with PU sensor
3. Difficulty lying still in supine position during the examination with PU sensor, which takes 5 to 10 minutes
4. Known allergy or sensitivity to any of the materials in PU sensor that gets in contact with the skin on the sacrum
5. Body weight ≥200 kg
6. Previous participation in the study
7. Mental inability, or language difficulties that results in difficulty to understand the meaning of participation in the study and / or signing the study consent,
8. Pregnancy

Primary outcomes:
measure: Number of pressure ulcers developed between visit 1 and 2
timeFrame: Up to 4 weeks
Secondary outcomes:
measure: Incidence of adverse events (AEs) and adverse device effects (ADEs)
timeFrame: Up to 2 days
Other outcomes:
measure: Proportion of pressure ulcers located in sacrum
timeFrame: Up to 4 weeks
measure: Combine Norton/RAPS with PU Sensor results
timeFrame: Up tp 4 weeks
measure: Compare PU sensor examinations for different skin types
timeFrame: Up to 4 weeks
measure: Compare PU sensor examinations for subjects with underlying disease
timeFrame: Up to 4 weeks
Locations:
city: Jönköping
country: Sweden
facility: Länssjukhuset Ryhov, Geriatriska kliniken
city: Oskarshamn
country: Sweden
facility: Oskarhamns Sjukhus
city: Uppsala
country: Sweden
facility: Medicin-Geriatriska kliniken Akademiska sjukhuset,
Study officials:
affiliation: PU Sensor
name: Anna-Christina Ek, RN,PhD
role: STUDY_CHAIR
References: