The relationship of subepidermal moisture and early stage pressure injury by visual skin assessment

Kim, Chul-Gyu; Park, Seungmi; Ko, Ji Woon; Jo, Seong Mu

doi:10.1016/j.jtv.2018.05.002

Cited by 27 publications

(54 citation statements)

References 11 publications

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“…Several studies have demonstrated the effectiveness of the SEM test as an objective biomarker in predicting or detecting deep and early stage PI/PUs. 15,17,18,[26][27][28][29][30][31] The role of localised inflammatory oedema/SEM was recognised as 'one of the earliest signs of cell death in pressure injuries' in the 2019 Clinical Practice Guidelines 24 emphasising the importance of SEM as an aetiological biomarker in predicting impending skin damage. 32 Results from this study add to the body of evidence that spatial SEM tests have clinical utility in aiding HCP determination of healthy versus damaged tissue.…”

Section: Discussionmentioning

confidence: 99%

Evaluating the sensitivity, specificity and clinical utility of algorithms of spatial variation in sub-epidermal moisture (SEM) for the diagnosis of deep and early-stage pressure-induced tissue damage

Gershon¹,

Okonkwo²

2021

J Wound Care

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Background: Sub-epidermal moisture (SEM) is a measurable biomarker detecting early pressure damage in order to objectively support current ‘gold standard’ skin tissue assessments (STA) for the detection of deep and early-stage pressure-induced injuries or ulcers (PI/PUs). Objective: A multi-site, dual arm, cross sectional, retrospective study was conducted to evaluate the sensitivity, specificity and clinical utility of spatial variation in SEM readings between healthy and damaged skin tissue. Method: The study enrolled 175 subjects: 125 with confirmed PI/PUs or suspected deep tissue injury (sDTI), and 50 confirmed healthy subjects. Expert principal investigators and PI/PU healthcare practitioners (HCPs) evaluating all subjects were trained in SEM measurements but blinded to clinical interpretation of SEM readings. Sequential and spatial SEM readings of the sacrum and heels, subjects' demographic data, STAs, risk assessment tool scores (RATS), pain assessment and potential confounders were recorded. Independent statistical analyses were performed. Results: Mean spatial SEM measures within subjects with healthy tissue and within subjects with damaged tissue were statistically similar. Mean spatial SEM measures within anatomies of subjects with damaged tissue were significantly different (p<0.05). There was no significant difference between spatial readings in healthy subjects. Algorithms computing a range of SEM delta thresholds indicated a sensitivity of 82–87% and a specificity of 51–88% at an SEM delta ≥0.6. Receiver operating characteristic (ROC) curves computed areas under the curve (AUC) of 0.7809–0.9181 (95% CI: 0.7221–0.8817, 0.8397–0.9545, p<0.0001) exceeding clinical judgement. Conclusion: These SEM data augment clinical decision-making for developing intact skin PI/PUs including sDTIs and Stage I PI/PUs. Informing HCPs of this subclinical, non-visible skin and tissue damage and providing opportunities for alternative PI/PU care pathways is an exciting prospect.

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Section: Discussionmentioning

confidence: 99%

Evaluating the sensitivity, specificity and clinical utility of algorithms of spatial variation in sub-epidermal moisture (SEM) for the diagnosis of deep and early-stage pressure-induced tissue damage

Gershon¹,

Okonkwo²

2021

J Wound Care

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“…Specifically, fourteen (14) publications map to the bottom of the pyramid reviewing SEM and its associated biomarkers, while four (4) relate to the 'increasing utility' layers [44][45][46]51]. The association of SEM as a biomarker in the development and progression of PIs is extensively reported in literature [23,[53][54][55][56][57]…”

Section: Clinical Profile and Post-marketing Findingsmentioning

confidence: 99%

Clinical profile of the SEM Scanner — Modernizing pressure injury care pathways using Sub-Epidermal Moisture (SEM) scanning

Bryant

Moore

Iyer

2021

Expert Review of Medical Devices

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Introduction: Pressure injuries (PIs) are a global health concern. Current PI care standards, including skin tissue assessments (STA) and health care professional (HCP) clinical judgment, diagnose visibly manifested PIs on the skin's surface, i.e. after the damage has already occurred. However, objective assessment of early-stage, non-visible, pressure-induced tissue damage is clinically impossible within the current standard of care. The SEM Scanner is the first device authorized by the Food and Drug Administration (FDA) that addresses this unmet clinical need. Areas covered: This review describes the novel sub-epidermal moisture (SEM) scanning technology of the device and summarizes the clinical safety and efficacy data that support the use of the scanner in routine PI care practice. Expert opinion: The clinical strategy for developing the SEM Scanner is noteworthy. SEM technology using anatomy-specific data enables HCPs to provide early PI prevention interventions before visible signs of tissue damage develop while the damage is still reversible. When adopted into routine practice, the device identifies an increased risk of developing PIs 5 days (median) earlier than STA. FDA clearance was based on bench studies and data from three foundational trials that demonstrate the diagnostic accuracy of the device algorithm significantly exceeding clinical judgment (p < 0.001).

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“…This local rise in tissue fluid contents is caused by the increased permeability of the vascular walls near the cell death site, which allows immune system cells to migrate from the blood circulation to the forming damage site. The biophysical measure of the aforementioned localised oedema is called sub‐epidermal moisture (SEM), which has been investigated in many clinical studies that altogether established the association of SEM changes with the early‐stage, not necessarily visible PUs …”

Section: Introductionmentioning

confidence: 99%

Phantom testing of the sensitivity and precision of a sub‐epidermal moisture scanner

Cohen

Gefen

2019

International Wound Journal

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The majority of pressure ulcers (PUs) including deep tissue injuries (DTIs) are preventable, and even reversible if detected in their early phase. One of the greatest barriers in PU prevention is that clinicians traditionally depended on subjective and qualitative techniques, particularly routine visual skin assessments that would only document existing, macroscopic PUs/DTIs, rather than preventing them or detecting them at their microscopic phase. At the early phase of cell damage, when a forming PU is still microscopic, there is a local increase in extracellular fluid contents within affected tissues, which is called sub-epidermal moisture (SEM). This new understanding has led to an emerging technology, a SEM Scanner (BBI LLC, Bruin Biometrics) that has been designed to effectively examine the health status of tissues, by measuring local changes in the biophysical SEM marker. In the present work, the SEM Scanner was tested under controlled laboratory conditions to experimentally determine its sensitivity and precision in identifying small (1 mL) water content changes in phantoms of the human heel and skull/face, which simulated common PU development scenarios. In both phantom configurations, the locally increased water contents resulted in consistent, statistically significant elevated SEM readings, which confirms that the SEM Scanner is able to detect fluid content changes that are as small as 1 mL. In agreement with a simplified theoretical (mathematical) SEM model, which was also developed here, changes in water contents had a consistent trend of effect on SEM delta values, which increased with each 1 mL increment in intra-tissue-substitute water contents. K E Y W O R D Sinflammatory response, oedema, pressure ulcer prevention, prophylaxis

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The relationship of subepidermal moisture and early stage pressure injury by visual skin assessment

Cited by 27 publications

References 11 publications

Evaluating the sensitivity, specificity and clinical utility of algorithms of spatial variation in sub-epidermal moisture (SEM) for the diagnosis of deep and early-stage pressure-induced tissue damage

Evaluating the sensitivity, specificity and clinical utility of algorithms of spatial variation in sub-epidermal moisture (SEM) for the diagnosis of deep and early-stage pressure-induced tissue damage

Clinical profile of the SEM Scanner — Modernizing pressure injury care pathways using Sub-Epidermal Moisture (SEM) scanning

Phantom testing of the sensitivity and precision of a sub‐epidermal moisture scanner

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