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Trial registered on ANZCTR


Registration number
ACTRN12621000946819
Ethics application status
Approved
Date submitted
24/05/2021
Date registered
20/07/2021
Date last updated
18/02/2022
Date data sharing statement initially provided
20/07/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Point of Care Subepidermal Moisture (SEM) Scanning Technology to Detect Pressure Injury: A Pilot Study
Scientific title
Point of Care Subepidermal Moisture (SEM) Scanning Technology to Detect Pressure Injury: A Pilot Randomised Controlled Trial
Secondary ID [1] 304254 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pressure Injury 321966 0
Condition category
Condition code
Skin 319689 319689 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 320591 0
Prevention
Comparator / control treatment
Participants in the control group will be visited by the RA at baseline, then daily Monday-Friday. The RA will conduct a visual skin assessment to detect PI, record the PI interventions being used, conduct a continence status assessment. The RA will make every effort to co-ordinate the data collection with the nurse and participant so that the visual skin assessment will be conducted during episodes of routine care e.g., during bathing or routine repositioning.
Routine Care
Participants in the intervention and control groups will receive routine PI prevention care. This care is reflective of the National Quality and Safety Standards, Comprehensive Care Standard and the International Prevention and Treatment of Pressure Injury Clinical Practice Guideline. Routine care includes risk screening and risk assessment, regular visual skin assessment, the use of specialist pressure redistribution reactive or active mattresses or other support surfaces, individualised regular repositioning and mobilisation programs, preventative skin care and multidisciplinary consultation
Participants in the control group will receive routine PI prevention care which we will not have any influence over.
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
Control group
Active

Outcomes
Primary outcome [1] 327573 0
We will assess feasibility of study procedures against the following pre-specified criteria:
i. Recruitment; at least 50% of those screened are eligible
ii. Recruitment; at least 75% of eligible patients will agree to participate
iii. Retention; at least 90% of participants will be retained throughout the study
iv. Intervention fidelity: at least 90% of participants get daily assessments as planned
v. Missing data; no more than 10% data missing for all secondary clinical outcomes
Assessment will be undertaken by audit and analyses of study database.
Timepoint [1] 327573 0
Primary time points for feasibility measures are at screening, at each data collection point- daily, Monday -Friday, at the end of the 14-day intervention period and at the end of the recruitment period.
Primary outcome [2] 327574 0
This composite outcome will assess the patient experience and acceptability of the intervention, by conducting semi-structured interviews following the administration of the intervention, using a study specific semi-structured interview guide.
Timepoint [2] 327574 0
Acceptability data (patient interviews) will be conducted once during the admission, following the administration of the intervention. Interviews will be conducted at a time and place mutually acceptable to the participant and the researcher.
Participants will provide written consent to participate in the interviews at the time of enrollment to the study.
Primary outcome [3] 327575 0
This composite outcome will assess the nurse's perspective on the feasibility and acceptability (nurse interview) of the intervention. To be eligible to participate in the interview, the nurse must have cared for a participant receiving the intervention. This outcome will be assessed using a study specific semi-structured interview guide.
Timepoint [3] 327575 0
The nurse interviews will be conducted once per nurse participant, during a period where that nurse is caring for a patient in the intervention group. Nurses will participate in individual or group interviews, at a time mutually agreeable to the Nurse and the researcher.
Secondary outcome [1] 395688 0
Cumulative incidence of hospital-acquired PI according to visual skin assessment, Cumulative incidence indicates the proportion of the population studied that develops a hospital-acquired PI over a specified time period and will be determined by visual skin assessment Monday to Friday by the RA.
Timepoint [1] 395688 0
At 14 days post enrollment.
Secondary outcome [2] 395689 0
Cumulative incidence tissue oedema according to SEM measurement results.
Timepoint [2] 395689 0
At 14 days post enrollment.
Secondary outcome [3] 395690 0
Pressure injury stage in those participants that developed hospital-acquired PI. Pressure injury severity will be classified or staged according to agreed international guidelines following completion of a visual skin assessment by the RA.
Timepoint [3] 395690 0
At each data collection point, ie once daily, Monday to Friday for 14 days or until the trial end points; development of sacral or heel HAPI, transfer to intensive care, hospital discharge or death, whichever occurs first.

Eligibility
Key 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.

Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
A central randomisation service independent of the study and researchers will be used.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random 1:1 allocation of patients in blocks of 2, 4 and 6 after they have consented will be undertaken.
A central randomisation service independent of the study and researchers will be used.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample Size
A total of 100 patients (50 per group) will be recruited to the study and randomised. This sample size is appropriate to determine feasibility and will yield data to inform an accurate sample size calculation for a future definitive randomised controlled trial (RCT). We aim to recruit approximately 10 patients per week. Our extensive experience in previous clinical trials recruiting patients at risk of hospital-acquired PI suggests this recruitment target is feasible.
Data analysis;
All randomised participant data will be analysed by intention to-treat, regardless of treatment received. All data will be entered into the IBM SPSS Statistics for Windows Version 27 (IBM Corp. 2012, Armonk, NY, USA). Descriptive statistics will be used to describe sample characteristics and feasibility data (means and standard deviations for continuous variables; frequencies and percentages for categorical variables). These results will be compared to pre-specified feasibility outcomes. Characteristics will be compared between the two groups. Differences in the presence of hospital-acquired PI and hospital-acquired PI stage between the intervention and control group will be explored using the Chi-square tests although we do not expect to find statistical significance due to the small sample.
The cumulative incidence of hospital-acquired PI according to visual skin assessment will be calculated by dividing the number of participants developing a hospital-acquired PI over a specified time period, divided by the total number of participants in the study population over a specified time period, multiplied by 100.
Inductive qualitative content analysis will be used to analyse interviews. Inductive content analysis will involve three steps..
1. Open coding: line-by-line coding will be undertaken, giving headings or sentences to each line that describe the content of the line
2. Grouping: similar heading and sentence codes will be grouped together; trying to reduce the number of codes by grouping them into subcategories
3. Categorization: subcategories will be grouped together if they showed similar events.

A sub-sample of 10 patients in the intervention arm and 10 nurses from participating units, will be invited to be interviewed about the acceptability of using the SEM scanner. This sample size is based on previous work, however, more or less interviews will be conducted dependent on when data saturation is determined by the research team.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
26/07/2021
Actual
26/10/2021
Date of last participant enrolment
Anticipated
25/10/2021
Actual
9/02/2022
Date of last data collection
Anticipated
15/11/2021
Actual
15/02/2022
Sample size
Target
100
Accrual to date
Final
100
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 19471 0
The Prince Charles Hospital - Chermside
Recruitment postcode(s) [1] 34062 0
4032 - Chermside

Funding & Sponsors
Funding source category [1] 308633 0
University
Name [1] 308633 0
Griffith University
Country [1] 308633 0
Australia
Primary sponsor type
Individual
Name
Professor Wendy Chaboyer
Address
National Health and Medical Research Council Centre of Research Excellence in Wiser Wound Care
Menzies Health Institute Queensland
Griffith University, Gold Coast campus, 1 Parklands Drive, Southport, QLD 4222. Building G01, Room 2.03
Country
Australia
Secondary sponsor category [1] 309501 0
None
Name [1] 309501 0
Address [1] 309501 0
Country [1] 309501 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308560 0
Royal Brisbane and Women's Hospital (RBWH) Human Research Ethics Committee
Ethics committee address [1] 308560 0
HREC Office,Executive Suites, Lower Ground Floor, Dr James Mayne Building, RBWH
RGO Office, Level 4, University of Queensland Centre of Clinical Research RBWH
Butterfield Street, Herston Qld 4029
Ethics committee country [1] 308560 0
Australia
Date submitted for ethics approval [1] 308560 0
29/03/2021
Approval date [1] 308560 0
21/05/2021
Ethics approval number [1] 308560 0
HREC/2021/QRBW/74291

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 111138 0
Dr Jill Campbell
Address 111138 0
National Health and Medical Research Council Centre of Research Excellence in Wiser Wound Care
Menzies Health Institute Queensland
Griffith University, Gold Coast campus,1 Parklands Drive, Southport, QLD 4222 Building G01 Room 2.05B
Country 111138 0
Australia
Phone 111138 0
+61 7 555 29553
Fax 111138 0
Email 111138 0
[email protected]
Contact person for public queries
Name 111139 0
Jill Campbell
Address 111139 0
National Health and Medical Research Council Centre of Research Excellence in Wiser Wound Care
Menzies Health Institute Queensland
Griffith University, Gold Coast campus,1 Parklands Drive, Southport, QLD 4222 Building G01 Room 2.05B
Country 111139 0
Australia
Phone 111139 0
+61 7 555 29553
Fax 111139 0
Email 111139 0
[email protected]
Contact person for scientific queries
Name 111140 0
Jill Campbell
Address 111140 0
National Health and Medical Research Council Centre of Research Excellence in Wiser Wound Care
Menzies Health Institute Queensland
Griffith University, Gold Coast campus, 1 Parklands Drive, Southport, QLD 4222, Building G01 Room 2.05B
Country 111140 0
Australia
Phone 111140 0
+61 7 555 29553
Fax 111140 0
Email 111140 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This is pilot data and context specific.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseThe effect of sub-epidermal moisture on pressure injury prevention strategies and incidence of pressure injuries: A feasibility pilot randomised controlled trial.2022https://dx.doi.org/10.1016/j.jtv.2022.07.008
N.B. These documents automatically identified may not have been verified by the study sponsor.