Pressure Ulcer
Conditions
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.
Interventions
DEVICEPU sensor
Device to assess microcirculation in sacrum area to find subjects at risk for pressure ulcer
Sponsors
Aurevia
PU sensor AB
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Masking description
The medical device will give an ID number but the results from the measurement will be masked until data base is locked (DBL). The data from the measurement will be available after DBL
Intervention model description
Double blind
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of pressure ulcers developed between visit 1 and 2 | Up to 4 weeks | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of adverse events (AEs) and adverse device effects (ADEs) | Up to 2 days | All adverse events (AEs) and adverse device effects (ADEs) incidence and severity following measurement with PU sensor up to 2 days after the baseline |
Other
| Measure | Time frame | Description |
|---|---|---|
| Proportion of pressure ulcers located in sacrum | Up to 4 weeks | The examination with PU sensor is in sacrum. Proportion of pressure ulcers that are located in sacrum for PU sensor high-risk group compared to PU sensor low-risk group. PU sensor high-risk group are those subjects who have a decreased blood flow at pressure from their own body, resulting in a High risk result from PU sensor. This proportion is compared for the two groups to evaluate if PU sensor can assess risk of pressure ulcers on the skin everywhere, or only in sacrum where the examination is done. |
| Combine Norton/RAPS with PU Sensor results | Up tp 4 weeks | All subject will use Norton or RAPS for risk assessment of pressure ulcer. The results from these risk assessments will be compared with the results from PU Sensor and pressure ulcers developed to explore if a combination of the scales and PU sensor would give a better view of subjects at risk. |
| Compare PU sensor examinations for different skin types | Up to 4 weeks | PU sensor is using PPG (Photoplethysmography) to assess blood flow in sacrum. Since light is used the the skin type (amount of pigment and in the skin etc) may affect the examination. |
| Compare PU sensor examinations for subjects with underlying disease | Up to 4 weeks | PU sensor is using PPG (Photoplethysmography) to assess blood flow in sacrum. Underlying diseases such as Hypertension and/or Diabetes may affect the examination. |
Countries
Sweden
Outcome results
None listed