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

NCT ID: NCT05458050

Last Updated: 2023-08-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 433 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-01
• Study Completion Date: 2023-08-24

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.

Conditions

Pressure Ulcer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

PU Sensor examination

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

Group Type: OTHER

PU sensor

Intervention Type: DEVICE

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

Interventions

PU sensor

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aurevia

INDUSTRY

Sponsor Role: collaborator

PU sensor AB

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anna-Christina Ek, RN,PhD

Role: STUDY_CHAIR

PU Sensor

Locations

Länssjukhuset Ryhov, Geriatriska kliniken

Jönköping, , Sweden

Oskarhamns Sjukhus

Oskarshamn, , Sweden

Medicin-Geriatriska kliniken Akademiska sjukhuset,

Uppsala, , Sweden

Countries

Sweden

Other Identifiers

CIP-PUS-1-001

Identifier Type: -

Identifier Source: org_study_id