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

Pressure Ulcer Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05458050
• Other study ID #: CIP-PUS-1-001
• Status: Completed
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: August 24, 2023

Study information

• Verified date: August 2023
• Source: PU sensor AB
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A double blind, non randomized, multicenter investigation

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 433
• Est. completion date: August 24, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pressure Ulcer
• Ulcer

Intervention

Device:
• PU sensor
Device to assess microcirculation in sacrum area to find subjects at risk for pressure ulcer

Locations

Country	Name	City	State
Sweden	Länssjukhuset Ryhov, Geriatriska kliniken	Jönköping
Sweden	Oskarhamns Sjukhus	Oskarshamn
Sweden	Medicin-Geriatriska kliniken Akademiska sjukhuset,	Uppsala

Sponsors (2)

Lead Sponsor	Collaborator
PU sensor AB	Scandinavian CRO

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Proportion of pressure ulcers located in sacrum	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.	Up to 4 weeks
Other	Combine Norton/RAPS with PU Sensor results	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.	Up tp 4 weeks
Other	Compare PU sensor examinations for different skin types	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.	Up to 4 weeks
Other	Compare PU sensor examinations for subjects with underlying disease	PU sensor is using PPG (Photoplethysmography) to assess blood flow in sacrum. Underlying diseases such as Hypertension and/or Diabetes may affect the examination.	Up to 4 weeks
Primary	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	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