SEM200-008 Study
Research type
Research Study
Full title
Evaluation of the SEM Scanner 200 for the Detection of Early Pressure Ulcers, a Multi-Site Longitudinal Study
IRAS ID
196233
Contact name
Colin Priestly
Contact email
Sponsor organisation
Bruin Biometrics Europe Ltd
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 4 months, 0 days
Research summary
This is a multi-site, longitudinal study to evaluate the safety and effectiveness of the SEM (Sub Epidural Moisture) Scanner device in detecting pressure ulcers (aka ‘bed sores’) in patients earlier than these would be identified in routine care.
Pressure ulcers (bedsores) are caused by damaged skin and can result in damaged skin and injuries that are difficult to treat. They are a common condition for patients who remain immobile in the same position in bed for an extended amount of time. Risk of pressure ulcers is experienced alike in the cognitively impaired and non-cognitively impaired. We would like to improve methods for detecting pressure ulcers.
As part of current standard care, clinicians use standard skin assessments to help detect pressure ulcers. The SEM Scanner that will be assessed in the study uses a sensor to measure damage below the skin caused by pressure.
This study will be conducted in hospitals in the UK and USA.
The study is expected to last up to 4 months at individual hospital sites. Participants will continue to receive standard of care skin assessments during their hospital stay. In addition to this, the research team will carry out daily readings using the SEM device on the participant.
REC name
North East - Newcastle & North Tyneside 1 Research Ethics Committee
REC reference
16/NE/0121
Date of REC Opinion
2 Jun 2016
REC opinion
Further Information Favourable Opinion