1. Purpose. Persons with spinal cord injury (SCI) are at high risk for pressure ulcers (PUs) throughout their lifetime due to decreased mobility and lack of sensation, coupled with other physiologic changes. The purpose of this study is to evaluate: a) the relationship between sub-epidermal moisture (SEM) (water content in skin and tissue), a measure of edema from inflammatory changes in the tissues, and non-visible pressure induced tissue damage (pre-stage I damage) and stage I PUs on the sacrum and buttocks in veterans with SCI, and b) address the strength of the relationship of SEM at various anatomic locations.
The specific aims for this study are to: 1) describe the relationship of SEM to pressure induced tissue damage over sequential weeks in veterans with SCI, 2) assess the relative strength of SEM and visual skin assessment as indicators of PUs at various anatomic locations, and 3) explore variation in SEM values based on PU prevention and skin health care actions. 2. Background. A non-invasive, practical method of detecting early PrUs has not been evaluated in the SCI population. Data from elderly nursing home residents at risk of developing PrU and pilot work with veterans with SCI provides support for evaluating use of SEM measures in veterans with Increase in SEM predicted an increased presence of erythema/stage 1 PrU the next week. Feasibility pilot data on SEM were collected with veterans with SCI from the Long Beach (LBVA) and Hines SCI Centers and observed over 16 weeks using an alternative handheld dermal phase meter. Veterans were followed in the hospital and home care settings with VSA and SEM obtained from the sacrum, ischium, trochanters, buttocks, and heels. A total of 31 patients were enrolled (Hines=9;LBVA=22). Results show that SEM was higher at sites with erythema present, and sites with scar tissue showed lower SEM values. However, 16 weeks is insufficient time for development of erythema in this population. 3. Expected Outcomes/Products. This study addresses issues of prevention and early detection. The practical impact of this study will be to more fully evaluate SEM as a tool for detecting early PrUs in veterans with SCI to inform a larger study of a multi-component preventive intervention based on the detection of early skin damage using SEM. 4. Methods and Research Plan. a. Study design and approach. A prospective cohort, descriptive study is proposed to evaluate the relationship between SEM measured with a handheld device and VSA of stage 1 PUs weekly for 40 weeks in veterans with SCI. Participants will receive weekly VSAs and SEM measures, medical record review, brief structured interviews, and PrU risk assessment. b. Population and sample. 100 SCI patients (50 each at Hines and LBVA), who are receiving outpatient or follow-up care are eligible, including women and minorities. c. Definition of the problem. If SEM can better detect pressure induced skin damage at early stages even for veterans with differing risk levels, allowing for prompt prevention interventions, evidence will be powerful for evaluating SEM through a clinical trial. The long-term objective is to evaluate SEM as a screening tool as a first step in designing more potent early intervention strategies to prevent serious PUs in veterans with SCI. d. Sources of data. Weekly VSA and SEM measures of subjects'sacrum, right and left heels, trochanters, ischium, and buttocks will be done at home visits or outpatient clinic visits for 40 weeks with the MoistureMeter D dermal phase meter (a light skin touch with the device wand for 8 seconds). Research staff will interview participants about skin health related behaviors weekly (activity level, strategies for pressure relief, nutrition).

Public Health Relevance

Significance of Research Currently veterans with SCI and their caregivers are expected to act as if they are constantly at high risk of developing PUs. However, this sense of urgency to perform preventive actions (essentially behavioral regimes) is difficult to maintain consistently over time because the available information is not specific enough to motivate such frequent, repetitive and intrusive behaviors. It is likely that if we can improve the quality of the information, then it may be easier to motivate persons with SCI to respond to changes in SEMs because it provides more meaningful information (e.g., a specific location shows signs of PU development within the next week). If the findings from the preliminary study are duplicated in this study with veterans with SCI, future intervention studies would focus on use of SEMs to reduce health care costs and improve important outcomes among veterans with SCI.

Agency
National Institute of Health (NIH)
Type
Non-HHS Research Projects (I01)
Project #
5I01RX000250-04
Application #
8868000
Study Section
Musculoskeletal/Orthopedic Rehabilitation (RRD2)
Project Start
Project End
Budget Start
Budget End
Support Year
4
Fiscal Year
2014
Total Cost
Indirect Cost
Name
Edward Hines Jr VA Hospital
Department
Type
DUNS #
City
Hines
State
IL
Country
United States
Zip Code
60141