EHOB Research News
by Dr. James Spahn, MD

Pressure ulcers are responsible for over 65,000 deaths per year in the United States alone. Aside from the human toll, the costs involved in treating this problem are enormous and escalating at an alarming rate annually. Taking into consideration all direct, indirect and peripheral costs, it is conservatively estimated that well over $25 billion total is spent annually on wound care in the United States currently. (Columbia Surgery, Department of Surgery, H. Brem, M.D., 2006). The urgency of this situation is not lost on those in the medical field, associated industries and the government as well.

Each year the government spends on average over $11 billion just on wound treatment and care for pressure ulcers alone. Insurance companies pay out millions annually for this same treatment, directly affecting premiums to increase annually for healthcare facilities. Current economic and standard inflationary effects add to this escalation.

Pressure ulcers can increase nursing time up to 50% and are very costly in time and resources. Total cost of manpower, resources and time invested in treatment continues to rise dramatically. (Alterescu, V.; Decubitus 1989). Specialized beds, cushions, dressings, off-loading devices, etc. add to the burdensome costs involved in treatment.

With the advent of the 78 million baby-boomers in the United States about to enter the early stages of the disease process, we are faced with overwhelming numbers of elderly people due to be cared for in long term facilities that need to be tended to by caregivers from a smaller subsequent generation.

The depth of this medical problem is huge, and the expense and pain of its devastation has been aggressively addressed by the government with strong policy changes and tough new interpretation of F-Tag314. The intent of the F-Tag314 is to ensure that a resident does not develop pressure ulcers unless his or her clinical condition rendered the ulcer unavoidable. This regulation stresses that healthcare facilities provide adequate care and services to promote the prevention of pressure ulcer developments; promote the healing of pressure ulcers that are present and prevent development of additional pressure ulcers. Failure to provide this care, attention and treatment will result in heavy penalties to facilities and individual clinicians.

So how do we alleviate the overall “pain” and stop the financial bleed of this medical problem? A cure for pressure ulcers is unreachable at this time, since the processes which contribute to them are numerous and complicated. Scientific understanding that most stage III, IV and unstageable pressure ulcers develop from deep tissue injury is becoming more carefully scrutinized by the healthcare industry, CMS and stakeholders. If these deep tissue injuries could be clinically visualized preceding a visible stageable pressure ulcer, care plans and protocols could be altered and implemented much earlier with perhaps enormous medical benefits and greatly improved outcomes. Medical professionals, CMS, insurance companies and healthcare advocates everywhere are looking at the development of deep tissue injury as a precursor to pressure ulcers with great interest.

EHOB has undertaken a deep and committed scientific investigation into getting out ahead of the clinical visualization of stageable pressure ulcers by exploring ways of predicting risk and early sub-clinical visualization of deep tissue injury, pressure ulcers and wounds.

After months of preparation and a surprisingly revealing initial feasibility study, EHOB launched two Western Institutional Review Board, (WIRB)-approved research studies in August of 2007. Fourteen healthcare facility sites in the Midwest are currently participating, with more joining in this summer. Objectives included massive data collection from consenting research subjects, most of which were geriatric. Our studies have also included thermographic imaging of all research subjects, with initial results providing image data that demonstrates early visualization of deep tissue injury and promising viability for future development.

The goal of EHOB’s research is to evaluate the utility of various noninvasive diagnostic measures used to assess wound status. Both skin color and temperature have been used for this purpose in clinical settings, but advances in the field of computer imaging add the advantage of quantitative precision and specificity to this task. Using these tools, EHOB has quantified temperature in a physiologically definitive ways and uses this capability to non-invasively measure and determine the depth and severity of cutaneous and deep tissue injuries.

In the past, the widespread use of infrared thermography was hampered by high costs and cumbersome methods. However, recent technological developments promise that inexpensive, easy-to-use infrared imagers for clinical use are close at hand. Computerized images will add further quantified specificity to diagnoses. Because of these converging factors, we believe that the methods described and developed in EHOB’s research will be of clinical significance and useful in the future development for use in the early detection of pressure ulcers/wounds.

One of the primary objectives of EHOB research is to identify the relationship of skin temperature variances and the correlation of development of deep tissue injury, pressure ulcers or wounds using infrared thermography on newly admitted patients to a long term care nursing facility or acute care facility. Concurrent data collection on each of the imaged subjects provides a complete clinical picture of possible associated and/or contributing risk factors. Completion of this study will look with particular interest at correlating the weighted indices of government documents, such as the extensive Minimum Data Set (MDS) questionnaire and cumulative data, (which is designed to investigate outcomes – such as pressure ulcers and wounds -- after they occur), with study intake data and serial thermal images, to investigate if a statistically viable, measurable risk can be accurately affixed to patients. In short, along with objective images of suspect tissue, pertinent risk factors assessed, and differential diagnosis produced, certain aspects of the valuable statistics-guided indices embedded in the MDS, the OASIS, AHRQ, CARE Tool and other accepted wound assessment tools will be incorporated to compile scientific comparison for prediction and prevention of pressure ulcers and wounds.

EHOB’s research will identify corresponding co-morbid factors that corroborate the temperature difference in the development of wounds, deep tissue injury and pressure ulcers. Using our WIRB-approved intake questionnaires, which were developed to directly correlate with the Minimum Data Set (MDS), and also using other established source documentation, such as the Braden Scale Scores, Norton Scale Scores, CARE Tool, OASIS data, and the MDS versions 2.0 as well as 3.0 with other longstanding accepted quantifiers as analytical validation, this study looks to correlate our research findings and cataloging for differential diagnosis. Study subject data from these source documents will be compared with a bank of data acquired from outside the study for further validation and mathematical comparison.

The fundamental principle of our application is to be able to use our research results to predict the formation of pressure ulcers prior to any externally visual development using an infrared thermography imaging system to locate and identify deep tissue injury.  Using thermal images, we can show temperature changes in the subcutaneous skin layers that show significant sub dermal injury and identify any abnormal pathophysiology prior to the visible formation of a pressure ulcer, (i.e. inflammation or ischemia), at early stages of a deep tissue injury.

EHOB, Inc., through unique method, research and application, has generated an exclusive new technique, data base, with symbiotic automated interpretive software to follow. Simultaneously, a unique, proprietary, handheld, wireless, thermographic imager exclusively designed for application in the healthcare industry, has been developed to house our software, and deliver bedside point-of-care diagnostic images of deep tissue injury, and other wounds. EHOB’s imaging research concurrently looks to initiate consideration of thermography as a viable tool and a medical standard for predicting and preventing pressure ulcers, and assisting in the identification and differential diagnosis of wounds.
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