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Point of Care Subepidermal Moisture (SEM) Scanning Technology to Detect Pressure Injury: A Pilot Study

Point of Care Subepidermal Moisture (SEM) Scanning Technology to Detect Pressure Injury: A Pilot Randomised Controlled Trial

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12621000946819
Enrollment
100
Registered
2021-07-20
Start date
2021-10-26
Completion date
2022-02-09
Last updated
2022-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

A pressure injury, sometimes known as a bedsore, is an injury to the skin and/or underlying tissue. They usually occur on bony areas of the body like the sacrum (tail bone) and heels. Pressure injuries, are caused by pressure, from not being able to move easily, lying or sitting in the same position for too long, or sliding down the bed or chair. Patients are at risk of developing pressure injuries in hospital. Pressure injuries are largely preventable, and are painful, may become infected, can take a long time to heal, and can mean a longer time spent in hospital. Better strategies are needed to prevent pressure injuries in hospital patients. The Subepidermal Moisture (SEM) Scanner is a tool that can be used to detect early changes in tissue that may develop into a pressure injury. The SEM Scanner does this by measuring changes in the tissue moisture and inflammation just below the skin. The differences in the tissue moisture and inflammation are caused by tissue damage early in the development of a pressure injury, and before the pressure injury can be seen. The SEM scanner can detect tissue changes 3-5 days before a pressure injury can be seen. The main aims of this study are to test whether using a SEM scanner in addition to routine care, compared to routine care only, in hospital patients, is acceptable and feasible, and to compare the number and severity of pressure injuries that develop in both groups.

Interventions

The subepidermal moisture (SEM) scanner measures changes in electrical properties of the tissue several millimetres below the skin as a result of inflammation secondary to damage caused by pressure/shear. This device reports the level of electrical change at a tissue site as a SEM value. Comparison of the inflamed area with nearby adjacent healthy tissue identifies the maximum difference between the SEM values and is known as the SEM-delta, the parameter of clinical interest. The higher the SEM-

The subepidermal moisture (SEM) scanner measures changes in electrical properties of the tissue several millimetres below the skin as a result of inflammation secondary to damage caused by pressure/shear. This device reports the level of electrical change at a tissue site as a SEM value. Comparison of the inflamed area with nearby adjacent healthy tissue identifies the maximum difference between the SEM values and is known as the SEM-delta, the parameter of clinical interest. The higher the SEM-delta, the higher the oedema and expected tissue damage at the site, with a SEM-delta reading of 0.6 indicative of a higher risk of pressure injury (PI). The intervention is SEM scanning of the sacrum and heels undertaken Monday to -Friday. The RA will record and report the SEM reading to the Nurse as either indicating or not indicating early tissue damage that may develop into a pressure injury. Participants in both groups will receive standard PI prevention care and be visited by the Research Assistant Monday to Friday who will conduct a visual skin assessment to detect PI, and data collection on PI prevention strategies implemented. Participants will be followed up for 14 days or until the trial end points; development of sacral or heel hospital-acquired PI, transfer to intensive care, hospital discharge or death, whichever occurs first. If a hospital-acquired PI is identified by the RA during visual skin assessment and data collection, the bedside nurse will be informed, and the participant will exit the study. Participants in the intervention group will receive routine PI prevention care which we will not have any influence over. Participants in the intervention group will have their sacrum and heels SEM Scanned once daily, Monday-Friday by the research assistant. The SEM Scanning process is non-invasive, painless and will take approximately 10 minutes to complete. It will feel like a small firm object is being held in several different location on the heels and the sacrum. We will endeavor to co-ordinate the SEM scanning process with the participant's routine pressure injury prevention care to minimise any disruption for the patient. The research assistant will report the SEM value to the bedside nurse as either normal 0.6 or less, or abnormal with a score of greater than or equal to 0.6, indicative of early tissue damage. The SEM results will also be recorded in the participants medical record. Feasibility Data The RA will keep logs (i.e., screening logs and intervention fidelity logs) to measure feasibility outcomes. Acceptability Outcomes The analysis and subsequent findings will provide insights into patients’, family members’ and healthcare professionals perceptions and experiences of intervention acceptability. The analysis and subsequent findings will provide insights into patients’, family members’ and healthcare professionals perceptions and experiences of intervention acceptability.

Sponsors

Professor Wendy Chaboyer
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

Inclusion Criteria; Patients • 18 years of age or older • Medical or surgical patient • Expected length of hospital stay of 48 hours or longer following recruitment • At risk of PI as measured by limited mobility (i.e., requiring physical or mechanical assistance to reposition or ambulate) • Screened within 36 hours of admission • Able to provide informed written consent either in person or via family member or legal guardian (henceforth known as proxy). Inclusion criteria for interviews; Patients • Consented to participate in the study • Agree to be interviewed • Randomised to intervention group Inclusion criteria for interviews; Nurses • Provided consent to be interviewed • Working in the participating ward for 3 months or longer • Employed full time or part time • Provided care to participants in the intervention group.

Exclusion criteria

Exclusion Criteria; Patients • Previous participation in this trial • Presence of sacral or heel PI • Presence of broken skin at sacrum or heels • Physical, structural, or other limitations preventing assessments required in this study (e.g., suspected, or actual injury preventing turning) • Receiving palliative care or dying Exclusion criteria for interviews; Patients • Randomised to the control group Exclusion Criteria for interviews; Nurses • Casual, relief or agency nurse • Provided care to participants in the control group

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026