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Completed

NCT Number: NCT05458050

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

A double blind, non randomized, multicenter investigation

Completed

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Key information

Conditions

Pressure Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Länssjukhuset Ryhov, Geriatriska kliniken, Jönköping, Sweden

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PU sensor

Device

Device to assess microcirculation in sacrum area to find subjects at risk for pressure ulcer

Primary outcomes

  1. Number of pressure ulcers developed between visit 1 and 2

    Time frame: 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 outcomes

  1. Incidence of adverse events (AEs) and adverse device effects (ADEs)

    Time frame: 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 outcomes

  1. Proportion of pressure ulcers located in sacrum

    Time frame: 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.

  2. Combine Norton/RAPS with PU Sensor results

    Time frame: 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.

  3. Compare PU sensor examinations for different skin types

    Time frame: 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.

  4. Compare PU sensor examinations for subjects with underlying disease

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

PU sensor AB

Industry

Collaborators

  • Aurevia

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 14, 2022
Registry last updated
Aug 25, 2023

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.

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