NCT05458050

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 433 (actual)
• Sponsor: PU sensor AB · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	PU sensor	Device to assess microcirculation in sacrum area to find subjects at risk for pressure ulcer

Timeline

• Start date: 2022-09-01
• Primary completion: 2023-06-30
• Completion: 2023-08-24
• First posted: 2022-07-14
• Last updated: 2023-08-25

Locations

3 sites across 1 country: Sweden