Evaluation of a novel device using capacitance of the detection of early pressure ulcers (PU), a multi-site longitudinal study

Introduction:

Pressure ulcers (PUs) have a detrimental effect on the health and wellbeing of patients and have a significant impact on resource costs in healthcare. Despite efforts, the problem persists, with estimated rates of up to 25% of hospital acquired pressure ulcers (HAPU’s) occurring in the acute care setting. Currently, nurses’ visual skin assessment (VSA) is the only method to detect PU development and guide prevention strategies, but can be inaccurate.

Subepidermal-Moisture (SEM) is a biophysical marker associated with local inflammation which occurs in the first stages of the wound healing process, up to 10 days prior to visible signs of PU development on the skin. Studies have demonstrated the feasibility of using SEM measurement for early detection of PUs, allowing for intervention for better outcomes.

Methods:

The purpose of this study was assess, in a prospective, longitudinal study, the use of SEM measurement for the early detection of PUs in patients before clinical judgement using VSA. At-risk patients were assessed daily and followed for up to 20 days. Skin care specialists (e.g., TVNs) conducted risk assessments and VSA. Nurse generalists assessed SEM using SEM Scanner. Participants and patients were blinded.

Results:

Over 189 at-risk patients were enrolled from 10 clinical study sites across the UK and US. In this population 40 patients developed PUs. SEM measurement is an accurate method for detecting incipient pressure damage: 87.5% of patients that developed PUs were previously detected by SEM. Importantly, SEM identified early signs of pressure damage under the skin by an average of 5 days earlier than VSA.  

Discussions:

With earlier detection using effective intervention, clinicians can reverse or stop the progression of PUs before significant damage to the patient. SEM measurement can augment current tools by providing objective data on damage under the skin, previously undetectable by nurses VSA.