An Investigation to Identify Subjects Admitted to Hospital With an Increased Risk of Developing Pressure Ulcers

Study Overview
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Brief Summary
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A double blind, non randomized, multicenter investigation

Detailed Description
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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.

Official Title
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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

Conditions
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Pressure Ulcer

Intervention / Treatment
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* Device: PU sensor


Participation Criteria
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Eligibility Criteria
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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, Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Interventional Model Description: Double blind
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: PU Sensor examination<br>Device:PU Sensor will assess the microcirculation in sacrum with and without pressure (subject will lay on side and after that on back) the total measurement time is 5-10 minutes | Device: PU sensor<br>* Device to assess microcirculation in sacrum area to find subjects at risk for pressure ulcer<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of pressure ulcers developed between visit 1 and 2 | This outcome is to evaluate if the subjects that have been assessed as at risk of developing pressure ulcers (using PU sensor) have actually developed pressure ulcers with a greater probability than those assessed as not at risk | Up to 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events (AEs) and adverse device effects (ADEs) | All adverse events (AEs) and adverse device effects (ADEs) incidence and severity following measurement with PU sensor up to 2 days after the baseline | Up to 2 days |