Evaluation of the SEM Scanner 200 for the Detection of Early Pressure Ulcers: A Multi-Site Longitudinal Study

NCT ID: NCT02701101

Last Updated: 2020-10-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 189 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2017-03-31

Brief Summary

This is a multi-site, longitudinal study to evaluate the use of the SEM Scanner as an adjunct to clinical judgment for detection of early pressure ulcers in patients before clinical judgment using signs of pressure ulcers from skin assessments. longitudinal study to evaluate the use of the SEM Scanner as an adjunct to clinical judgment for detection of early pressure ulcers in patients before skin assessments.

Detailed Description

All subjects are followed for a minimum of 6 days to a maximum of 21 days upon enrollment or until exit from the study . Enrolled subjects are assessed once daily throughout the follow-up period. Assessments are performed at the sacrum and both heels; if one or more locations are not assessable with the SEM Scanner, only the assessable locations are assessed. Each study site may include one or two wound care specialist (or a similarly trained clinician; the "Specialist") and one or two clinician/patient care provider(s) (the "Generalist") who perform assessments in the study.

Study assessments include (i) daily Risk Assessment and (ii) daily Skin Assessment performed by the Specialist blinded to the SEM readings; and (iii) daily SEM Scanner readings collected by the Generalist blinded to the Risk and Skin assessments. The outcome of interest is the diagnosis of a pressure ulcer by the Specialist using clinical judgment. The Specialist stages any diagnosed pressure ulcers according to NPUAP/EPUAP 2014 guidelines.

Note: If applicable, enrolled subjects continue to receive facility's standard of care practices for pressure ulcer preventive care. Participation in the study does not alter patient's standard of care.

This study involved two study objectives -

1. A primary objective to demonstrate the sensitivity and specificity of the SEM Scanner 200 in detecting early pressure ulcers before clinical judgment ("diagnose PU before clinical judgment").

2. A secondary objective to determine how early the SEM Scanner can detect signs before visually identified via clinical judgment ("time to detection").

Conditions

Pressure Ulcers

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Daily Skin Assessments (SoC and SEM Scanner Readings)

The SEM Scanner 200 measures sub-epidermal moisture ("SEM"), which has been studied as an indicator of localized edema characteristic of pressure-induced tissue damage. Daily assessments were performed at the sacrum and both heels unless the anatomical location(s) were not assessable. Daily assessments included:

1. Risk Assessment (standard of care; Braden, Waterlow, or Norton)

2. Skin Assessment (standard of care visual skin assessments utilizing tactile and visual cues)

3. SEM Scanner readings ("test" variable in this study). Standard of care evaluations were conducted by individuals meeting the definition of Specialist specified in the study protocol whereas separate individuals meeting the definition of Generalist performed SEM Scanner 200 measurements. Specialists were blinded to the assessment by the Generalists, and vice versa.

Group Type: OTHER

Use of SEM200 Scanner daily

Intervention Type: DEVICE

From enrollment to exit,daily SEM Scanner readings collected on Sacrum and Heels

Assessment and treatment of Pressure Ulcers using SOC

Intervention Type: OTHER

Nurse review of Skin risk and skin assessment, notes in chart to assess the frequency to turn patient, use of a specialist bed to prevent or treat early pressure ulcers

Interventions

Use of SEM200 Scanner daily

From enrollment to exit,daily SEM Scanner readings collected on Sacrum and Heels

Intervention Type: DEVICE

Assessment and treatment of Pressure Ulcers using SOC

Nurse review of Skin risk and skin assessment, notes in chart to assess the frequency to turn patient, use of a specialist bed to prevent or treat early pressure ulcers

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Greater or equal to 55 years of age

2. At risk of developing a pressure ulcer at time of enrollment as defined by one or more of the following:

1. PU Risk Score - Braden < 15; Waterlow ≥ 10; or Norton ≤ 18

2. Poor mobility; e.g., Braden mobility subscore ≤ 2; Waterlow mobility subscore > 2; Norton mobility subscore ≤ 2; or poor mobility according to clinical judgment (chair- or bed-bound)

3. Poor nutrition; e.g., Braden nutrition subscore ≤ 2; Waterlow nutrition subscore > 2; or poor nutrition according to clinical judgment

4. Medical procedure (e.g. surgery, x-ray, etc.) involving immobility and inability to change position lasting 4 hours or longer

3. Evaluable by the study team for a minimum of 6 consecutive days upon enrollment

4. Willing and able to provide informed consent (or by proxy)

Exclusion Criteria

1. Unhealed (including newly diagnosed) pressure ulcer at any anatomical site at the time of enrollment

2. Broken skin at the sacrum and both heels that prevents collection of SEM Scanner readings from all three anatomical locations; possible assessment at only one or two locations is not grounds for exclusion

3. Moisture lesion or incontinence associated dermatitis at the sacrum

4. Physical, structural, or other limitations preventing assessments required in this study (e.g., suspected or actual injury preventing turning)

5. Presence of any condition(s) or injury(ies) which compromises the subject's ability to complete this study

6. Per clinical decision of the study Investigator, diminished decision-making capacity which might impact compliance or completion with study procedures

7. Patient modesty concerns on the part of the subject (or their proxy) that might impact collection of SEM Scanner readings at the anatomical location (heels and sacrum) to be assessed

• Minimum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bruin Biometrics, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Thomas Jefferson Hospital

Philadelphia, Pennsylvania, United States

Countries

United States

References

Okonkwo H, Bryant R, Milne J, Molyneaux D, Sanders J, Cunningham G, Brangman S, Eardley W, Chan GK, Mayer B, Waldo M, Ju B. A blinded clinical study using a subepidermal moisture biocapacitance measurement device for early detection of pressure injuries. Wound Repair Regen. 2020 May;28(3):364-374. doi: 10.1111/wrr.12790. Epub 2020 Jan 21.

Reference Type: RESULT

PMID: 31965682 (View on PubMed)

Other Identifiers

SEM200-008

Identifier Type: -

Identifier Source: org_study_id