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

NCT05458050 | Completed

• 1 other identifier: CIP-PUS-1-001
• Study Type: interventional
• Target: 433
• Locations: 1 country
• Sites: 3

Brief Summary

A double blind, non randomized, multicenter investigation

Conditions

Pressure Ulcer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Incidence of adverse events (AEs) and adverse device effects (ADEs)

  Up to 2 days

Other Outcomes (4)

• Proportion of pressure ulcers located in sacrum

  Up to 4 weeks

• Combine Norton/RAPS with PU Sensor results

  Up tp 4 weeks

• Compare PU sensor examinations for different skin types

  Up to 4 weeks

Study Arms (1)

PU Sensor examination

OTHER

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

Interventions

PU sensor DEVICE

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

PU Sensor examination

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• PU sensor AB: lead
• Aurevia: collaborator

Study Sites (3)

Länssjukhuset Ryhov, Geriatriska kliniken

Jönköping, 55185, Sweden

Location

Oskarhamns Sjukhus

Oskarshamn, 57251, Sweden

Location

Medicin-Geriatriska kliniken Akademiska sjukhuset,

Uppsala, 75185, Sweden

Location

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Anna-Christina Ek, RN,PhD

  PU Sensor

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: 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
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Double blind

Study Record Dates

• First Submitted: June 15, 2022
• First Posted: July 14, 2022
• Study Start: September 1, 2022
• Primary Completion: June 30, 2023
• Study Completion: August 24, 2023
• Last Updated: August 25, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

SE (3)