Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000756123p
Ethics application status
Submitted, not yet approved
Date submitted
30/04/2019
Date registered
22/05/2019
Date last updated
22/05/2019
Date data sharing statement initially provided
22/05/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Exploring Body Morphology, Skin Microcirculation and Microclimate in Patients with Critical Illness.
Scientific title
Exploring Body Morphology, Skin Microcirculation and Microclimate in Patients with Critical Illness (the EXAMINE study); a prospective observational pilot study.
Secondary ID [1] 298107 0
none
Universal Trial Number (UTN)
Trial acronym
the EXAMINE Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
skin integrity 312631 0
critical illness 312632 0
Condition category
Condition code
Skin 311129 311129 0 0
Other skin conditions

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The study population will include all patients with a critical illness admitted to the intensive care unit (ICU) who meet the inclusion criteria.
Patients will be screened for eligibility 5 days a week with data collection commenced on the day of enrolment and continued for 3 days a week until ICU discharge or 28 days of enrolment in the study.
During data collection the buttock area (sacrum) skin surface will be assessed for changes in heat, humidity and visual signs of skin injury.
The researcher will complete the procedures for the study. If a skin injury is found it will be discussed with clinical nurse at the bedside so it can be managed according to standard hospital procedures. If a stage III or IV injury is found, the hospital skin integrity service will be contacted to confirm category and manage according to standard hospital procedures.
Intervention code [1] 314333 0
Not applicable
Comparator / control treatment
This is an observational study of a cohort, There is no control or individual comparison between each individual body shape type.

Data will be reported on each body shape when compared to all other body shapes. The body shape types include triangle, inverted triangle, rectangular, rounded and hourglass.
Control group
Active

Outcomes
Primary outcome [1] 319901 0
Sub-epidermal moisture levels.
This outcome will be measured with the Sub-epidermal moisture (SEM) Scanner™. The SEM scanner™ is a hand-held device that assesses the bioimpedance of a localised area of tissue (The bioimpedance values reflect the microscale oedema build up) and has been proven to objectively and reliability detects pre-stage I pressure injury (PI) before damage becomes clinically visible. The SEM Scanner™ was designed to be used in a clinical setting as part of PI prevention programs to detect tissue damage three to 10 days before visual skin damage or PI formation is detected.
Timepoint [1] 319901 0
Patients are recruited as close to ICU admission as possible.

Screening will occur five days a week. The first data collection will be commenced upon day of enrolment and then data collection will occur three days a week Monday/ Wednesday/ Friday until 28 days of enrolment or until ICU discharge, whichever occurs first.
Secondary outcome [1] 369822 0
Pressure injury (PI) development at the sacrum

A PI is localised damage to the skin and underlying soft tissue usually over a bony prominence…as a result of intense and/or prolonged pressure or pressure in combination with shear. The stages of PIs will be classified by the National Pressure Ulcer Advisory (NPUAP), European Pressure Ulcer Advisory Panel (EPUAP), and Pan Pacific Pressure Injury Alliance (PPPIA) (2014). A Stage I PI is non-blanchable erythema of intact skin, usually located over a bony prominence. A Stage II PI is partial thickness skin loss with exposed dermis, it may also present as an intact or open serum-filled blister. A Stage III PI is full thickness skin loss with visible subcutaneous tissue but no visible bone, tendon, or muscle. A Stage IV PI is considered full thickness tissue loss with exposed bone, tendon, or muscle. The wound may appear sloughy, with eschar and undermining, or tunnelling may be present. An unstageable PI is of an unknown depth with full thickness skin and tissue loss. Damage can only be assessed once the slough/eschar is removed. A suspected deep tissue injury (DTI) is a persistent non-blanching injury with a deep red or purple discolouration and intact skin or blood-filled blister.
Timepoint [1] 369822 0
The first data collection will be commenced upon day of enrolment and then data collection will occur three days a week Monday/ Wednesday/ Friday until 28 days of enrolment or until ICU discharge, whichever occurs first.

Eligibility
Key inclusion criteria
• 18 years and over; and
• ICU length of stay expected to be greater than 24 hours.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• are unable to turn into the full lateral turn position for a short time period, as determined by medical or nursing clinicians;
• are managed in isolation under contact, droplet or airborne precautions;
• have a break to the skin integrity, including PI, moisture lesion, or incontinence-associated dermatitis at the sacrum region;
• have a previously healed PI over the sacrum;
• are receiving palliative care or the withdrawal of;
• are agitated and not able to obey commands as determined by medical or nursing clinicians;
• are deemed to be in too much pain to turn, as determined by medical or nursing clinicians;
• are haemodynamically unstable, as determined by medical or nursing clinicians; or
• are currently enrolled in three intensive care research protocols.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
The study will be an exploratory study with the intention to recruit 100–150 participants. Participant recruitment will be stratified according to body shape type (e.g. 30 participants per body shape type).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2019
Actual
Date of last participant enrolment
Anticipated
3/02/2020
Actual
Date of last data collection
Anticipated
6/03/2020
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 13674 0
Royal Brisbane & Womens Hospital - Herston
Recruitment postcode(s) [1] 26357 0
4029 - Herston

Funding & Sponsors
Funding source category [1] 302638 0
University
Name [1] 302638 0
Queensland University of Technology
Country [1] 302638 0
Australia
Primary sponsor type
University
Name
Queensland University of Technology
Address
Cnr Musk and Victoria Park Rd
Kelvin Grove QLD 4059
Country
Australia
Secondary sponsor category [1] 302552 0
None
Name [1] 302552 0
Address [1] 302552 0
Country [1] 302552 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 303264 0
Royal Brisbane and Women's Hospital Human Research Ethics Committee
Ethics committee address [1] 303264 0
Executive Suites, Lower Ground Floor, Dr James Mayne Building
Royal Brisbane and Women's Hospital
Butterfield Street, Herston QLD 4029
Ethics committee country [1] 303264 0
Australia
Date submitted for ethics approval [1] 303264 0
29/04/2019
Approval date [1] 303264 0
Ethics approval number [1] 303264 0

Summary
Brief summary
Aim:the purpose of this study is to explore the different body types to see if there is a relationship with body type and the temperature and moisture build up around the buttock area skin during a critical illness. As a secondary outcome the study will also explore whether certain body types are more likely to develop skin injuries known as pressure injuries (PI) when compared to the other body types during a critical illness.
Participants: All patients with a critical illness admitted to the ICU who meet the inclusion criteria will be screened for eligibility. Recruitment will be stratified according to body shape.
Methods: Quantitative method. Prospective, observation, exploratory study design.
Expected outcomes: This type of study has never been done before. This study will build on the known science about the skin and critical illness and it will provide new information on factors which can contribute to PI development for patients in the ICU.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 93062 0
Mrs Jessica Ingleman
Address 93062 0
Centre for Clinical Nursing
Building 34, Level 5
Royal Brisbane & Women’s Hospital
Butterfield Street, Herston QLD 4029
Country 93062 0
Australia
Phone 93062 0
+61 731387453
Fax 93062 0
Email 93062 0
[email protected]
Contact person for public queries
Name 93063 0
Jessica Ingleman
Address 93063 0
Centre for Clinical Nursing
Building 34, Level 5
Royal Brisbane & Women’s Hospital
Butterfield Street, Herston QLD 4029
Country 93063 0
Australia
Phone 93063 0
+61 731387453
Fax 93063 0
Email 93063 0
[email protected]
Contact person for scientific queries
Name 93064 0
Jessica Ingleman
Address 93064 0
Centre for Clinical Nursing
Building 34, Level 5
Royal Brisbane & Women’s Hospital
Butterfield Street, Herston QLD 4029
Country 93064 0
Australia
Phone 93064 0
+61 731387453
Fax 93064 0
Email 93064 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
The study results will be disseminated in de-identified and aggregate form only.


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
No additional documents have been identified.