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.

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.

A blinded clinical study using a subepidermal moisture biocapacitance measurement device for early detection of pressure injuries.

This study aimed to evaluate the sensitivity and specificity of subepidermal moisture (SEM), a biomarker employed for early detection of pressure injuries (PI), compared to the "Gold Standard" of clinical skin and tissue assessment (STA), and to characterize the timing of SEM changes relative to the diagnosis of a PI. This blinded, longitudinal, prospective clinical study enrolled 189 patients (n = 182 in intent-to-treat [ITT]) at acute and post-acute sites (9 USA, 3 UK). Data were collected from patients' heels and sacrums using a biocapacitance measurement device beginning at admission and continuing for a minimum of 6 days to: (a) the patient developing a PI, (b) discharge from care, or (c) a maximum of 21 days. Standard of care clinical interventions prevailed, uninterrupted. Principal investigators oversaw the study at each site. Blinded Generalists gathered SEM data, and blinded Specialists diagnosed the presence or absence of PIs. Of the ITT population, 26.4% developed a PI during the study; 66.7% classified as Stage 1 injuries, 23% deep tissue injuries, the remaining being Stage 2 or Unstageable. Sensitivity was 87.5% (95% CI: 74.8%-95.3%) and specificity was 32.9% (95% CI: 28.3%-37.8%). Area under the receiver operating characteristic curve (AUC) was 0.6713 (95% CI 0.5969-0.7457, P < .001). SEM changes were observed 4.7 (± 2.4 days) earlier than diagnosis of a PI via STA alone. Latency between the SEM biomarker and later onset of a PI, in combination with standard of care interventions administered to at-risk patients, may have confounded specificity. Aggregate SEM sensitivity and specificity and 67.13% AUC exceeded that of clinical judgment alone. While acknowledging specificity limitations, these data suggest that SEM biocapacitance measures can complement STAs, facilitate earlier identification of the risk of specific anatomies developing PIs, and inform earlier anatomy-specific intervention decisions than STAs alone. Future work should include cost-consequence analyses of SEM informed interventions.

Serial Surgical Debridement of Common Pressure Injuries in the Nursing Home Setting: Outcomes and Findings.

OBJECTIVE: This study examined the efficacy of bedside surgical debridement in a nursing home population. MATERIALS AND METHODS: A retrospective chart review was performed of sacrum, sacrococcyx, coccyx, ischium, and trochanter (SSCIT) region pressure injuries in the Skilled Wound Care practice (Los Angeles, CA). The patient population was refined from 2128 to 227 patients visited 8 or more times during nursing home stays found to have 1 or more SSCIT pressure injuries. Of the 227 patients, there were approximately 319 individual SSCIT wounds, with an average of 1.4 SSCIT wounds per patient. Bedside surgical debridement was performed using a sharp excisional technique on 190 of 319 (59.5%) SSCIT wounds. RESULTS: An analysis of the square surface area of the 190 debrided wound sites revealed a mean ulcer surface area of 20.76 cm2. Of those 190 wound sites, 138 (73%) had a reduction in square surface area, and 52 (27%) had no change or an increase in square surface area and were categorized as nonresponders. Of the wounds that did improve by a reduction in wound surface area, the average wound surface area reduction was 6.81 cm2 at 4 weeks (25%), 8.91 cm2 reduction at 8 weeks (33%), and 10.87 cm2 reduction at 12 weeks (40%). From the 190 wound sites, there were a total of 43 (23%) wounds that had a square surface area of 0 (reepithelialized), which has a healing rate of 23%. CONCLUSION: Traditional bedside debridement provides excellent results in reducing the square surface area for a majority of wounds. Whether used alone or as an adjunct to any treatment plan, the use of surgical sharp equipment aids in achieving good wound healing and advancing the rate of wound closure. Although wound healing requires many components, sharp debridement can effectively remove devitalized tissue and is a proven significant component to advancing wound closure.