WHS guidelines for the treatment of pressure ulcers-2023 update.

The major populations at risk for developing pressure ulcers are older adults who have multiple risk factors that increase their vulnerability, people who are critically ill and those with spinal cord injury/disease. The reported prevalence of pressure ulcers in the United States is 2.5 million. However, this estimate is derived from acute care facilities and does not include people who are living at home or in nursing facilities. Despite the implementation of hospital and facility-based preventive measures, the incidence of pressure ulcers has not decreased in decades. In addition to the burden of pain, infection and death, it is estimated that hospital-acquired pressure ulcers cost the health system $26.8 billion annually with over 50% of the cost attributed to treating Stage 3 and 4 pressure injuries. Thus, it is critical to examine the literature and develop guidelines that will improve the outcomes of this complex and costly condition. This guideline update is a compendium of the best available evidence for the treatment of Pressure Ulcers published since the last update in 2015 and includes a new section based on changing demographics entitled 'Palliative wound care for seriously ill patients with pressure ulcers'. The overall goal of the Wound Healing Society Guideline project is to present clear, concise and commercial free guidelines that clinicians can use to guide care, that researchers can use to develop studies that will improve treatment and that both clinicians and researchers can use to understand the gaps in our knowledge base.

Genomic Biomarkers Can Provide a Deeper Understanding of Recurrent Pressure Injuries.

OBJECTIVE: To identify genetic biomarkers predisposing individuals with spinal cord injury (SCI) to recurrent pressure injuries (PIs). METHODS: Repeated measures of the transcriptome profile of veterans with SCI at three Veterans Spinal Cord Injuries and Disorders Centers. Exclusion criteria included having significant active systemic disease at time of enrollment. Researchers obtained comprehensive profiles of clinical and health factors and demographic information relevant to PI history at enrollment and at each follow-up visit by reviewing patients' medical charts. Whole blood samples were collected at 6- to 12-month intervals for 2 to 4 years. In addition to DNA profiling with whole genome sequencing of the patients, RNA sequencing was performed to assess pathways associated with PI risk. RESULTS: Whole genome sequencing analysis identified 260 genes that showed increased prevalence of single-nucleotide variations in exonic regions with high (>20) combined annotation-dependent depletion scores between persons with high versus low intramuscular adipose tissue levels when cross-referenced with persons who had recurrent PIs. Gene set enrichment analysis using Hallmark and KEGG (Kyoto Encyclopedia of Genes and Genomes) gene sets of these candidate genes revealed enrichment in genes encoding proteins involved in fatty acid metabolism (P < .01). Further, RNA sequencing revealed upregulated activity in biological senescence pathways and downregulated activity in antimicrobial protection pathways. CONCLUSIONS: Genomic biomarkers may complement electronic health records to support management of complex interactive health issues such as risk of recurrent PIs in people with SCI. These findings may also be leveraged for homogeneous phenotypic grouping of higher-risk individuals.

Development and use of a porcine model with clinically relevant chronic infected wounds.

Chronic ischemic wounds affect millions of people causing significant pain and disability. They can be considered to be stalled in the inflammatory stage and cannot heal without additional measures. A valid animal model is necessary to evaluate the efficacy of topical wound healing therapies and wearable technologies. A porcine model, although higher in cost, maintenance, and space requirements, is superior to the commonly used rodent or rabbit model for wound healing. Previous studies have shown that pig wounds have greater similarity to human wounds in responses to a variety of treatments, including wound dressings and antibiotics. The current study created a porcine model of large chronic wounds to assess a wearable electroceutical technology, with monitoring of healing variables and infection. Electroceutical therapy is the only adjunctive treatment recommended for chronic wound therapy. A porcine model of large chronic wounds of clinically realistic size was created and utilized to evaluate a wearable electroceutical biotechnology. Multivariate non-invasive assessment was used to monitor wound progression over multiple timepoints. Outcomes suggest that a wearable electrostimulation bandage, has the potential to offer therapeutic benefit in human wounds. The tested wearable device provides the same proven effectiveness of traditional electroceutical therapy while mitigating commonly cited barriers, including substantial time requirements, and availability and complexity of currently available equipment, preventing its implementation in routine wound care. The model is also appropriate for evaluation of other wearables or topical therapeutics.

An End-User's Personal Perspective on the Need of Consumer Involvement in Research.

There is growing understanding that the consumer's voice in research needs to be stronger. Translational research studies need consumer inclusion in order to be effectively implemented. This narrative article provides the perspective of a Veteran with spinal cord injury (SCI) who is an active member of several study teams and serves as a Consumer Advocate, providing the voice of the person with SCI. Factors that drive people to develop new research ideas are considered. Consumer involvement offers helpful insight into project outcomes that are valuable to the end-user. It is also recognized that data can be interpreted in several different ways depending on the observer. Including the consumer in a research project enables another interpretation, creating a more complete evaluation. Participating in health research is becoming a new standard for persons with many different illnesses and diseases. Greater things are accomplished by physicians, healthcare scientists, engineers, and healthcare consumers interacting together to increase both the quality of research projects and the quality of life for everyone involved, especially the person with the disorder. There will be more acceptance of ideas or projects when consumers are involved from the early steps and learn how the process works from beginning to end.

Interactive Evidence-Based Pressure Injury Education Program for Hospice Nursing: A Quality Improvement Approach.

PURPOSE: The purpose of this quality improvement (QI) project was to develop and implement an interactive, evidence-based pressure injury (PI) education program and evaluate the impact on frontline hospice nursing staff knowledge and practice. PARTICIPANTS AND SETTING: The QI setting was a 12-bed inpatient hospice unit in a tertiary care Veterans Affairs (VA) Medical Center in Cleveland, Ohio. Nineteen licensed and unlicensed hospice nursing staff participated in this pre-/postworkshop project. APPROACH: Chart audit determined baseline PI incidence and prevalence on the inpatient hospice unit. Interviews with key leaders informed the need to develop and implement innovative PI education opportunities. A literature review determined existing standards regarding the benefits of PI education for nursing staff but did not reveal measurable targets in hospice settings. We developed a PI education intervention based on Kolcaba's Theory of Comfort framework and a Plan-Do-Study-Act (PDSA) performance improvement model. Education was delivered in 7 workshops, lasting 2 hours each. Knowledge, practice, and comfort for inpatient hospice nursing staff were evaluated at baseline and 8 weeks following the final refresher visit. Workshop satisfaction was collected once using standard program evaluation forms after final workshop delivery. OUTCOMES: We observed a significant improvement in staff PI knowledge (P = .001) and practice (P = .001) after initial workshop attendance and repeat engagement (P = .001). There was a large magnitude of effect for overall knowledge change (d = 1.04); similarly PI care planning and practice showed a large magnitude of effect and significant improvement (P = .001, d = 2.64). Staff comfort with job duties was stable with low effect size (mean 4.52, d = 0.04), and satisfaction with the workshop education was high (100% agreement with trainer effectiveness). IMPLICATIONS FOR PRACTICE: We found that frontline hospice nursing staff knowledge and practice improved after attendance at our evidence-based PI education program. Results of this QI project have stimulated ongoing discussion on how to sustain this program in our hospice setting.

A review of animal models from 2015 to 2020 for preclinical chronic wounds relevant to human health.

SIGNIFICANCE: Chronic wounds fail to heal in a timely manner and exhibit sustained inflammation with slow tissue repair and remodelling. They decrease mobility and quality of life, and remain a major clinical challenge in the long-term care of many patients, affecting 6.5 million individuals annually in the U.S., decreasing mobility and quality of life. Treatment costs are a major burden on the U.S. healthcare system, totalling between $25 and $100 billion annually. Chronic wound severity depends upon several factors such as comorbidities, severity of tissue damage, infection and presence of necrosis and vary greatly in their healing mechanisms. In vivo animal models are critical for studying healing pathways of chronic wounds and seek to replicate clinical factors for trials of topical, systemic, and device-based therapeutics. This comprehensive review discusses murine, rat, lapine, canine, feline and porcine models of chronic wounds. RECENT ADVANCES: Foundational chronic wound models for several species are discussed together with refinements and advances in the time period between 2015 and 2020 which have the potential for broad utility in investigating biological and device-based wound treatment therapies for human health. CRITICAL ISSUES: Chronic wounds fail to heal in a timely manner and have differing aetiologies, rendering no single in vivo animal model universally applicable. FUTURE DIRECTIONS: Further studies are required to develop clinically relevant chronic wound animal model which reflect the clinical reality of the various influences of age, disease, comorbidities and gender on delayed healing and enhance understanding of the biological processes of human wound healing.

What Lies Beneath: Why Some Pressure Injuries May Be Unpreventable for Individuals With Spinal Cord Injury.

OBJECTIVE: To investigate intersections between pressure injury (PrI) history, muscle composition, and tissue health responses under physiologically relevant loading conditions for individuals with spinal cord injury (SCI). DESIGN: Repeated measures study design with annual follow-up for up to 3 years. SETTING: Tertiary care center. PARTICIPANTS: Persons with SCI (N=38). Exclusion criteria included having an open pelvic region PrI at the time of recruitment, presence of systemic disease, and/or known sensitivity to contrast. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Gluteal muscle composition, ischial interface pressures, tissue oxygenation. RESULTS: Ischial region mean interface pressures are the same for individuals with or without a PrI history. Tissue oxygenation is lower during sitting for persons with a PrI history. Individuals with >15% gluteal intramuscular fat were statistically highly significantly (P<.001) more likely to have a history of severe or recurrent PrI. Intramuscular adipose tissue (IMAT) levels within the gluteal muscle may remain low over time or muscle tissue in the gluteal muscle region may be almost entirely replaced by IMAT. In the current study cohort, it was found that muscle composition also continues to change over time even for individuals with long-standing SCI. CONCLUSIONS: Soft-tissue compositional changes, specifically IMAT, provides a reliable indicator of PrI history and may provide a key to personalized PrI risk status for persons with SCI. The current findings confirm that interface pressure mapping alone is a limited indicator for PrI development.

Preliminary development of an advanced modular pressure relief cushion: Testing and user evaluation.

STUDY AIM: Effective pressure relief cushions are identified as a core assistive technology need by the World Health Organization Global Cooperation on Assistive Technology. High quality affordable wheelchair cushions could provide effective pressure relief for many individuals with limited access to advanced assistive technology. MATERIALS: Value driven engineering (VdE) principles were employed to develop a prototype modular cushion. Low cost dynamically responsive gel balls were arranged in a close packed array and seated in bilayer foam for containment and support. Two modular cushions, one with high compliance balls and one with moderate compliance balls were compared with High Profile and Low Profile Roho® and Jay® Medical 2 cushions. METHODS: ISO 16480-2 biomechanical standardized tests were applied to assess cushion performance. A preliminary materials cost analysis was carried out. A prototype modular cushion was evaluated by 12 participants who reported satisfaction using a questionnaire based on the Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST 2.0) instrument. RESULTS: Overall the modular cushions performed better than, or on par with, the most widely prescribed commercially available cushions under ISO 16480-2 testing. Users rated the modular cushion highly for overall appearance, size and dimensions, comfort, safety, stability, ease of adjustment and general ease of use. Cost-analysis indicated that every modular cushion component a could be replaced several times and still maintain cost-efficacy over the complete cushion lifecycle. CONCLUSION: A VdE modular cushion has the potential provide effective pressure relief for many users at a low lifetime cost.

Development of a Sitting MicroEnvironment Simulator for wheelchair cushion assessment.

STUDY AIM: Pressure ulcers (PU) are a common comorbidity among wheelchair users. An appropriate wheelchair cushion is essential to relieve pressure and reduce PU development during sitting. The microenvironment, specifically excessive heat and moisture, impacts risk for PU development. An effective wheelchair cushion should maintain a healthy microenvironment at the seating interface. Measurement of heat and moisture can characterize microenvironmental conditions at the wheelchair cushion interface under load. We describe the development of a Sitting MicroEnvironment Simulator (SMES) for the reliable assessment of wheelchair cushion microenvironments. MATERIALS: The prototype SMES was developed for use mounted on a Materials Testing Systems (MTS) 810(®) uniaxial servo-hydraulic loading rig and used to assess microenvironmental conditions for Jay Medical Jay 2(®), Roho High Profile Dry Floatation(®) and Low Profile Dry Floatation(®) cushions and a novel modular gel cushion. METHODS: Each cushion was assessed for two hours in triplicate. The SMES was used to load the cushions to 300N ± 10N, with an interface surface temperature of 37 °C±1 °C and fluid delivery of 13 mL/h±1 mL/h of water. Interface temperature and humidity were measured at the left ischial tuberosity (IT) region every five minutes. RESULTS: Heat and moisture responses were similar for the three commercial cushions. The modular gel cushion stayed cooler for at least 15 min longer than any commercial cushion. CONCLUSIONS: The SMES maintained performance to technical specifications for over one hundred hours of total testing and is a reliable tool for characterizing the microenvironmental conditions of wheelchair cushions.

Personalized prediction of chronic wound healing: an exponential mixed effects model using stereophotogrammetric measurement.

STUDY AIM: Stereophotogrammetric digital imaging enables rapid and accurate detailed 3D wound monitoring. This rich data source was used to develop a statistically validated model to provide personalized predictive healing information for chronic wounds. MATERIALS: 147 valid wound images were obtained from a sample of 13 category III/IV pressure ulcers from 10 individuals with spinal cord injury. METHODS: Statistical comparison of several models indicated the best fit for the clinical data was a personalized mixed-effects exponential model (pMEE), with initial wound size and time as predictors and observed wound size as the response variable. Random effects capture personalized differences. RESULTS: Other models are only valid when wound size constantly decreases. This is often not achieved for clinical wounds. Our model accommodates this reality. Two criteria to determine effective healing time outcomes are proposed: r-fold wound size reduction time, t(r-fold), is defined as the time when wound size reduces to 1/r of initial size. t(δ) is defined as the time when the rate of the wound healing/size change reduces to a predetermined threshold δ < 0. Healing rate differs from patient to patient. Model development and validation indicates that accurate monitoring of wound geometry can adaptively predict healing progression and that larger wounds heal more rapidly. Accuracy of the prediction curve in the current model improves with each additional evaluation. CONCLUSION: Routine assessment of wounds using detailed stereophotogrammetric imaging can provide personalized predictions of wound healing time. Application of a valid model will help the clinical team to determine wound management care pathways.

Not just quantity: gluteus maximus muscle characteristics in able-bodied and SCI individuals--implications for tissue viability.

STUDY AIM: Some individuals with spinal cord injury (SCI) remain pressure ulcer (PU) free whilst others experience a recurring cycle of tissue breakdown. Detailed analysis of gluteal muscle characteristics may provide insights to local tissue viability variability. The study hypothesis was that SCI individuals have altered muscle composition compared to able-bodied (AB). MATERIALS: Ten AB and ten SCI received a supine pelvic CT scan, with contrast. METHODS: Cross-sectional area (CSA) and overall muscle volume were derived using image analysis. Gluteal muscle tissue type was classified at the S2/S3 sacral vertebrae midpoint, the superior greater trochanters margin (GT) and the inferior ischial tuberosities margin (IT) using the linear transformation Hounsfield Unit scale. RESULTS: SCI gluteal CSA was less than for AB throughout the muscle, with the greatest relative atrophy at the IT (48%). Average AB gluteal volume was nearly double SCI. Eight SCI had over 20% infiltrative adipose tissue, three with over 50%. SCI gluteal CSA and intramuscular fat infiltration were significantly negatively correlated (p < 0.05). SCI IT axial slices showed less lean muscle and higher intramuscular fat infiltration than more proximally (p < 0.05). CONCLUSION: SCI gluteal muscle characteristics were indicative of impaired tissue viability. SCI disuse muscle atrophy was anticipated; the analytic approach further indicated that intramuscular atrophy was not uniform. SCI muscle composition showed increased proportions of both low density muscle and adipose tissue. CT scan with contrast is effective for gluteal muscle characterization. This assessment technique may contribute to determination of personalized risk for PU development and other secondary complications.

Flexible and Scalable Dry Conductive Elastomeric Nanocomposites for Surface Stimulation Applications.

OBJECTIVE: The study describes the development and testing of a dry surface stimulation flexible electrode (herein referred to as Flexatrode), a low-cost, flexible, and scalable elastomeric nanocomposite using carbon black (CB) and polydimethylsiloxane (PDMS). METHODS: Flexatrodes composed of CB and PDMS were developed and tested for mechanical and functional stability up to 7 days. Uniform CB distribution was achieved by optimizing the dispersion process using toluene and methyl-terminated PDMS. Electromechanical testing in the through thickness directions over a long-term duration demonstrated stability of Flexatrode. Thermal stability of Flexatrode for up to a week was tested and validated, thus mitigating concerns of heat generation and deleterious skin reactions such as vasodilation or erythema. RESULTS: 25 wt.% CB was determined to be the optimal concentration. Electrical and thermal stability were demonstrated in the through thickness direction. CONCLUSION: Flexatrode provides stable electrical properties combined with high flexibility and elasticity. Electrotherapy treated chronic wounds were 81.9% smaller than baseline at day 10. Wounds that received an inactive device (device without any electrical stimulation) were 58.1% smaller than baseline and wounds that received standard of care treatment were 62.2% smaller than baseline. SIGNIFICANCE: The increasing need for wearable bioelectronics requiring long-term monitoring/treatment has highlighted the limitations of sustained use of gel-based electrodes. These can include skin irritation, bacterial overgrowth at the electrode site, gel dehydration over time, and signal degradation due to eccrine sweat formation. Flexatrode provides stable performance in a nanocomposite with scalable fabrication, thus providing a promising platform technology for wearable bioelectronics.

Subacute and Chronic Spinal Cord Injury: A Scoping Review of Epigenetics and Secondary Health Conditions.

Background: Epigenetics studies the impact of environmental and behavioral factors on stable phenotypic changes; however, the state of the science examining epigenomic mechanisms of regulation related to secondary health conditions (SHCs) and neuroepigenetics in chronic spinal cord injury (SCI) remain markedly underdeveloped. Objective: This scoping review seeks to understand the state of the science in epigenetics and secondary complications following SCI. Methods: A literature search was conducted, yielding 277 articles. The inclusion criteria were articles (1) investigating SCI and (2) examining epigenetic regulation as part of the study methodology. A total of 23 articles were selected for final inclusion. Results: Of the 23 articles 52% focused on histone modification, while 26% focused on DNA methylation. One study had a human sample, while the majority sampled rats and mice. Primarily, studies examined regeneration, with only one study looking at clinically relevant SHC, such as neuropathic pain. Discussion: The findings of this scoping review offer exciting insights into epigenetic and neuroepigenetic application in SCI research. Several key genes, proteins, and pathways emerged across studies, suggesting the critical role of epigenetic regulation in biological processes. This review reinforced the dearth of studies that leverage epigenetic methods to identify prognostic biomarkers in SHCs. Preclinical models of SCI were genotypically and phenotypically similar, which is not reflective of the heterogeneity found in the clinical population of persons with SCI. There is a need to develop better preclinical models and more studies that examine the role of genomics and epigenomics in understanding the diverse health outcomes associated with traumatic SCI.

Physiological measurements of tissue health; implications for clinical practice.

Pressure mapping alone insufficiently describes tissue health. Comprehensive, quantitative non invasive assessment is crucial. Interface pressures (IPs) and transcutaneous blood gas levels [transcutaneous tissue oxygen (T(c) PO(2) )] were simultaneously assessed over both ischia and the sacrum to investigate the hypotheses: (i) tissue oxygenation decreases with sustained applied pressure; (ii) tissue oxygen and IP are inversely correlated in loaded soft tissues; (iii) multisite assessments are unnecessary because healthy individuals are symmetrical. Measurements were taken at 5-minute intervals for 20 minutes in both sitting and supine lying for a cohort of 20 able-bodied adults. There were no statistically significant changes over time for either variable in 96% of timepoint comparisons. Specifically, no significant differences were seen between 10 and 20 minutes in either position. These findings imply that a 10-minute assessment can reliably indicate tissue health and that tissue may adapt to applied load over time. No statistically significant correlations between T(c) PO(2) and IP were observed. However, the left and right ischia were significantly different for both variables in supine lying (P < 0.001) and for sitting IP (P < 0.010). Thus, even in this healthy cohort, postural symmetry was not observed and should not be assumed for other populations with restricted mobility. If a multisite technique cannot be used, repeated tissue health assessments must use the same anatomic location.

Meet the Editor.

I provide a brief personal introduction including my professional background, interests, and qualifications. I invite authors with a wide diversity of interests to submitted manuscripts to the journal. My overarching goals is to improve the journal's impact through (1) strategic partnerships with professional organizations and research consortia, (2) publication of targeted Special Collections focused on topics of interest to the field and (3) improved efficiency in manuscript submission and review.

An Absorbent, Flexible, Transparent, and Scalable Substrate for Wound Dressings.

Objective: Wound dressings that create and maintain a moist environment provide the optimal conditions for wound healing by increasing the rate of epithelialization and angiogenesis. However, current wound dressings require periodic removal which exposes the wound to the surrounding environment, thereby increasing the likelihood for infection and drying out the wound itself. There remains an unmet medical need for the development of an absorbent, flexible, and transparent wound dressing that can conform to the irregular geometry of the wound for a long-term duration. Herein, we report the development of AFTIDerm, an Absorbent, Flexible, Transparent, and Inexpensive moisture-management wound dressing using Polyvinyl alcohol (PVA) as the host material. Methods:AFTIDerm substrates of varying glycerol concentrations (1 wt%, 3 wt%, 5 wt%, 7 wt%, and 10 wt%) were fabricated and tested. The mechanical, absorption, and biological properties of AFTIDerm were evaluated. Results: We found that 5% glycerol served as the optimal concentration for AFTIDerm. The biocompatibility, absorptive capabilities, and scalability render PVA/glycerol an ideal material composition for wound dressings. Benchtop experimentation and pre-clinical testing demonstrate AFTIDerm as a platform for use in wound dressings. Discussion/Conclusion: The development of AFTIDerm broadens the translational utility of this materials platform not only as a material for wound dressings to minimize dressing changes in low to moderate exudate environments, but also as a potential substrate material for smart bandages. Clinical and Translational Impact Statement- AFTI Derm, an absorbent, flexible, and transparent wound dressing, maintains the moist environment required for healing while enabling monitoring of healing without removal and disruption to the wound bed.

Development of Foot Displacement Detection Algorithm for Power Wheelchair Footplate Pressure and Positioning.

Inadvertent lower extremity displacement (ILED) puts the feet of power wheelchair (PWC) users at great risk of traumatic injury. Because disabled individuals may not be aware of a mis-positioned foot, a real-time system for notification can reduce the risk of injury. To test this concept, we developed a prototype system called FootSafe, capable of real-time detection and classification of foot position. The FootSafe system used an array of force-sensing resistors to monitor foot pressures on the PWC footplate. Data were transmitted via Bluetooth to an iOS app which ran a classifier algorithm to notify the user of ILED. In a pilot trial, FootSafe was tested with seven participants seated in a PWC. Data collected from this trial were used to test the accuracy of classification algorithms. A custom figure of merit (FOM) was created to balance the risk of missed positive and false positive. While a machine-learning algorithm (K nearest neighbors, FOM=0.78) outperformed simpler methods, the simplest algorithm, mean footplate pressure, performed similarly (FOM=0.62). In a real-time classification task, these results suggest that foot position can be estimated using relatively few force sensors and simple algorithms running on mobile hardware.Clinical Relevance- Foot collisions or dragging are severe or life-threatening injuries for people with spinal cord injuries. The FootSafe sensor, iOS app, and classifier algorithm can warn the user of a mis-positioned foot to reduce the incidence of injury.

Wheelchair Mobility-Related Injuries Due to Inadvertent Lower Extremity Displacement on Footplates: Analysis of the FDA MAUDE Database From 2014 to 2018.

OBJECTIVES: The aims of the study were to assess reports of wheelchair mobility-related injuries from inadvertent lower extremity displacement (ILED) on footplates, which were submitted to the Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE) database during 2014-2018, characterize injury types, and evaluate MAUDE data quality. METHODS: A systematic MAUDE database review was performed. Annual reports were searched using keywords: (a) "power wheelchair" and "injury" and (b) "mechanical (also known as manual) wheelchair" and "injury." Reports related to injuries from ILED on the footplate were reviewed. RESULTS: Reports of 1075 wheelchair injuries were found across the review period. Twenty nine (3%) met our inclusion criteria. The most common source of reports was "manufacturer." The wheelchair was unavailable for evaluation in 55.17% of reports. Manufacturers' submission dates (number of days that passed after they were notified) ranged from 3 to 159. Reported injuries decreased by 60% from 2014 to 2018. The end user used a power wheelchair for all but one report. The most common injuries were single fractures, multiple fractures, wounds/cuts/infections, and amputations (in order of incidence). The most common mechanism was the foot slipping off the footplate during wheelchair mobility. CONCLUSIONS: We observed inherent weaknesses in the MAUDE database reporting process and a concerning level of reporting bias. Although there were limited reports of injuries related to ILED on the footplate during wheelchair mobility, the injuries reported were significant. More standardized reporting of the mechanism and impact of these injuries is needed to better inform wheelchair design, prescription, and patient/family education.

Development of Predictive Informatics Tool Using Electronic Health Records to Inform Personalized Evidence-Based Pressure Injury Management for Veterans with Spinal Cord Injury.

BACKGROUND: Pressure injuries (PrI) are serious complications for many with spinal cord injury (SCI), significantly burdening health care systems, in particular the Veterans Health Administration. Clinical practice guidelines (CPG) provide recommendations. However, many risk factors span multiple domains. Effective prioritization of CPG recommendations has been identified as a need. Bioinformatics facilitates clinical decision support for complex challenges. The Veteran's Administration Informatics and Computing Infrastructure provides access to electronic health record (EHR) data for all Veterans Health Administration health care encounters. The overall study objective was to expand our prototype structural model of environmental, social, and clinical factors and develop the foundation for resource which will provide weighted systemic insight into PrI risk in veterans with SCI. METHODS: The SCI PrI Resource (SCI-PIR) includes three integrated modules: (1) the SCIPUDSphere multidomain database of veterans' EHR data extracted from October 2010 to September 2015 for ICD-9-CM coding consistency together with tissue health profiles, (2) the Spinal Cord Injury Pressure Ulcer and Deep Tissue Injury Ontology (SCIPUDO) developed from the cohort's free text clinical note (Text Integration Utility) notes, and (3) the clinical user interface for direct SCI-PIR query. RESULTS: The SCI-PIR contains relevant EHR data for a study cohort of 36,626 veterans with SCI, representing 10% to 14% of the U.S. population with SCI. Extracted datasets include SCI diagnostics, demographics, comorbidities, rurality, medications, and laboratory tests. Many terminology variations for non-coded input data were found. SCIPUDO facilitates robust information extraction from over six million Text Integration Utility notes annually for the study cohort. Visual widgets in the clinical user interface can be directly populated with SCIPUDO terms, allowing patient-specific query construction. CONCLUSION: The SCI-PIR contains valuable clinical data based on CPG-identified risk factors, providing a basis for personalized PrI risk management following SCI. Understanding the relative impact of risk factors supports PrI management for veterans with SCI. Personalized interactive programs can enhance best practices by decreasing both initial PrI formation and readmission rates due to PrI recurrence for veterans with SCI.

Biomarkers for recurrent pressure injury risk in persons with spinal cord injury.

Objective: To investigate potential linkages between pressure injury (PrI) recurrence following spinal cord injury (SCI) and muscle-based and circulatory biomarkers, specifically fatty metabolites and inflammatory cytokines. Design: Observational study. Setting: Tertiary Care Center. Participants: 30 individuals with complete or incomplete SCI. Study participants either had never developed a PrI (Group I) or had a history of recurrent PrI (Group II). Interventions: Not applicable. Outcome Measures: Gluteal muscle histology, immunohistochemistry, muscle-based and circulatory fatty metabolites and inflammatory cytokines. Results: Gluteal intramuscular adipose tissue (IMAT) was greater than 15% in most Group II (83%) individuals. Muscle tissue histology confirmed intramuscular structural differences. Fatty acid binding protein 4 (FABP4) and fatty acid binding protein 3 (FABP3) were reliably detected in muscle and blood and significantly correlated with IMAT (P < 0.001). FABP4 was significantly higher in Group II muscle and blood (P < 0.05). FABP3 was significantly higher in Group I muscle (P < 0.05). Circulatory FABP3 levels were lower for Group I. Inflammatory biomarkers were more reliably detected in blood. Colony-Stimulating Factor-1 was slightly higher in Group II muscle. Circulatory interleukin-13 was significantly higher (P < 0.01) in Group I. Vascular endothelial growth factor (VEGF-A) was significantly increased (P < 0.05) in Group I muscle and blood. Conclusion: Identifying individuals with SCI at highest risk for recurrent PrI may impact patient management. IMAT content evaluation illustrates that muscle quality is a key biomarker. Low circulatory inflammatory biomarker expression potentially limits clinical significance for between group differences. Circulatory levels of FABP4 hold great potential as a recurrent PrI risk biomarker.