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

  • days left to enroll
  • participants needed
  • sponsor
    PU sensor AB
Updated on 16 October 2022


A double blind, non randomized, multicenter investigation


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.

Condition Pressure Ulcer
Treatment PU sensor
Clinical Study IdentifierNCT05458050
SponsorPU sensor AB
Last Modified on16 October 2022


Yes No Not Sure

Inclusion Criteria

Given their written consent to participate in the study
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

Existing pressure ulcer or damage to the skin around the sacrum where the PU sensor plate and pillow are to be placed
Fever ≥38 ºC, within 30 minutes before the examination with PU sensor
Difficulty lying still in supine position during the examination with PU sensor, which takes 5 to 10 minutes
Known allergy or sensitivity to any of the materials in PU sensor that gets in contact with the skin on the sacrum
Body weight ≥200 kg
Previous participation in the study
Mental inability, or language difficulties that results in difficulty to understand the meaning of participation in the study and / or signing the study consent
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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