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Trial registered on ANZCTR


Registration number
ACTRN12619000763145p
Ethics application status
Submitted, not yet approved
Date submitted
9/05/2019
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
Do foam dressings prevent pressure sores?
Scientific title
EffEctiveness of Prophylactic fOam dressings in the prevention of saCral pressure injuries in at-risk hospitalised patients: The EEPOC Trial
Secondary ID [1] 298032 0
Nil known
Universal Trial Number (UTN)
U1111-1232-2254
Trial acronym
The EEPOC Trial
Linked study record
NA

Health condition
Health condition(s) or problem(s) studied:
Sacral Hospital Acquired Pressure Injury 312519 0
Condition category
Condition code
Skin 311058 311058 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This multi-site RCT will take place at four acute-care teaching public hospitals in South East Queensland. A consecutive sample of all eligible adult patients admitted to the participating medical-surgical wards who are assessed as at risk of developing a sacral hospital-acquired pressure injury (HAPI), will be invited to participate in the trial. Based on screening criteria, the ward Nurse Unit Manager or designate will mention the trial to the patient. If they agree to be approached, the Registered Nurse Research Assistant will then undertake the formal screening and consent patients.

Participants allocated to the intervention group will receive a prophylactic silicone foam dressing (Mepliex Border Sacrum®) in addition to routine care according to the hospital procedures informed by state governance and international standards.

The Registered Nurse Research Assistant (ResN) will take a baseline photograph of the participant’s sacrum and then apply the dressing. The dressing and sacral skin will be visually inspected by the ResN every day for up to 14 days, or until discharge or death, whichever occurs first. The dressing will be replaced every 3 days as per the manufacturer recommendations / instructions, and/or will be removed and replaced in instances where the dressing is not intact, rolled-up, soiled or saturated. Where there is evidence of skin irritation due to the dressing, the dressing will be removed, the skin reaction reported using standard hospital incident reporting protocols and the patient exited from the clinical study. Where the patient has developed persistent urinary and/or faecal incontinence, the sacral dressing will be removed and the patient exited from the clinical study.

The daily photograph of the sacrum will be sent to a blinded-to-intervention assessor for evaluation who will be trained in pressure injury staging in accordance with nationally recognised classification system. This classification is based on the depth of skin and tissue damage, from non-blanchable erythema (stage 1) to full thickness tissue loss (stage 4) and unstageable damage and suspected deep tissue injury. The blinded outcome assessor will visually inspect the photographs daily for evidence of a sacral HAPI using standardised assessment method and notify the ResN and researchers of the result within the same day of receiving the photograph.

Where a Stage 1 (i.e., non-balanceable erythema) is suspected by the ResN, the patient will be repositioned where possible, the site reassessed after 30 minutes and the photograph taken. The patient will exit from the clinical study if it is determined that they have developed a sacral HAPI. If the patient has a sacral HAPI, then they will be included in the economic evaluation of treatment for follow-up for an additional 14 days (for a total of 28 days), or until discharge from hospital or death. Where there is no development of sacral HAPI, the patient will be followed-up for up to 14 days or until discharge from hospital or death.

A parallel process evaluation will also be undertaken. We will identify contextual factors and co-interventions related to clinical contexts, hospital procedures or individual clinical practice that may operate concurrently with the intervention. Fidelity will assess whether delivery of the intervention to participants as outlined in the study protocol, procedure manual, and training processes are consistent. Patient comfort and satisfaction with the dressing will enable assessment of intervention acceptability from participants’ perspective to enable refinements. We will also evaluate whether participants’ level of participation had any moderating effect on the results of the trial (as measured by the Patient Participation in Pressure Injury Prevention scale, a valid and reliable scale).

Strategies for assessment and monitoring of adherence to content and coverage will include:
• A standardized training program including presentations, practical training exercises and group reflection/discussion will be developed.
• The program will include training resources including the Standard Operating Procedure (which will instructions of taking photographs of the sacrum, and advice on editing the image to ensure all photographs are similar – i.e., blurring the skin around the scarum to remove any sign of the dressing), Research Electronic Data Capture (REDCap) User Guide, Data Definition Dictionary, and script for recruitment
• Training and subsequent assessment of inter-rater reliability of blinded-to-intervention outcome assessors to ensure assessment of sacral photographs will be based on international guidelines. Regular audits undertaken during the trial will monitor inter-rater reliability to indicate if additional training is required.
• The use of REDCap for completion of the electronic Case Report Forms by the Registered Nurse Research Assistant (ResN) will include completion of screening, enrollment and allocation logs, baseline data collection and daily outcome assessment measures will be regularly monitored by the Clinical Trial Coordinator (CTC) / Chief Investigator (CI) to identify missing data, user-errors or any outstanding tasks.

Strategies for adherence to frequency and duration (i.e. dose) will include:
• Participant and staff perspectives (e.g. regarding difficulties / issues with the dressing) will be assessed via semi-structured interviews and focus groups, respectively, with data analysed thematically.
• Outcome assessments for each participant recorded in REDCap will include daily patient satisfaction and comfort surveys, and other data relevant to the dose of the intervention (i.e. whether the trial dressing is insitu, how often the dressing is applied/changed/reapplied). This data will be regularly monitored by the CTC and CI.
• Regular team and site meeting will be scheduled to monitor progress and manage issues as they arise.
• ResN will be encouraged to document queries and concerns about aspects of the study including site-related issues via email to the CTC and CI and/or closed Yammer group, so all team members can read and respond to issues as they arise.

The standardized training program will involve one 6-hour, trial-specific, face-to-face group training workshop conducted at one of the four sites and attended by all Registered Nurse Research Assistants. The workshop will be conducted 1 month to 2 weeks prior data collection commencing. Top up sessions will be conducted throughout the trial by Registered Nurses who are product specialists (as needed). The training program will cover the following content:
• Overview of the trial, including background information, aims/objectives, methods and ethics.
• Overview of data collection processes and timepoints (e.g. selection and withdrawal of participants, baseline data collection, daily outcome assessments, randomisation).
• Intervention delivery, including specific training relevant to the use of the trial dressing and emphasis on importance of adherence/ fidelity.
• The principals of Good Clinical Practice.
• Safety reporting – definitions of AEs/SAEs and processes for reporting.
• Using REDCap.

The training will be administered by the researchers who are registered nurses or health professionals with clinical and research expertise relevant to wound care and conducting clinical trials.
Intervention code [1] 314294 0
Prevention
Comparator / control treatment
Participants in the control group will receive routine care only according to the hospital procedures informed by state governance and international standards. Routine care may consist of regular skin inspection and assessment, nursing care via use of a pressure redistribution overlay on a standard mattress, or removal of a standard mattress and replacement with a pressure redistributing mattress, possible multidisciplinary review and second hourly repositioning.
Participants will also have their sacrum photographed every day following recruitment but will not have a dressing applied to the area. The photograph will be edited in the same way as the intervention group before being sent to a blinded-to-intervention assessor for evaluation. As with the intervention group, if the patient in the control group develops a sacral HAPI, then they will be included in the economic evaluation of treatment for up to 28 days, or until discharge from hospital or death. Where there is no development of HAPI, the patient will be followed-up for up to 14 days or until discharge from hospital or death.
Control group
Active

Outcomes
Primary outcome [1] 319857 0
Number of sacral HAPI assessed by daily photographs of participants’ sacrum (for details regarding the evaluation of photographs, refer to description of intervention(s) / exposure).
Timepoint [1] 319857 0
Daily, for up to 14 days.
Secondary outcome [1] 369725 0
Time to onset of sacral HAPI in days, assessed by daily photographs of participants’ sacrum (for details regarding the evaluation of photographs, refer to description of intervention(s) / exposure).
Timepoint [1] 369725 0
Daily, for up to 14 days.
Secondary outcome [2] 369726 0
Number of sacral HAPIs (incidence rates per 1000 bed days) assessed using daily photographs of the participants’ sacrum (for details regarding the evaluation of photographs, refer to description of intervention(s) / exposure).

Timepoint [2] 369726 0
Daily, for up to 14 days.
Secondary outcome [3] 369727 0
Severity of sacral HAPI, i.e., depth of tissue damage, assessed using daily photographs of the participants’ sacrum (for details regarding the evaluation of photographs, refer to description of intervention(s) / exposure).
Timepoint [3] 369727 0
Daily, for up to 14 days.
Secondary outcome [4] 369728 0
Cost-effectiveness of routine care plus the foam dressing compared to routine care alone assessed by:
- Calculating differences in resource use and cost from hospital medical records and observational data collection (e.g. cost of dressing, cost of time per minute such as time to apply the dressing and move the patient).
- Incremental cost per sacral HAPI avoided assessed by the difference in the costs of prevention (i.e. measured to the 14-day trial endpoint) divided by the difference in sacral PI incidence.
- Benefits of prevention (e.g. any difference in costs of sacral HAPI treatment and the opportunity cost of hospital length of stay between groups) measured in dollars using data from the extended 28-day follow up.
Timepoint [4] 369728 0
Daily, for up to 28 days.
Secondary outcome [5] 369729 0
Process evaluation: Implementation fidelity (i.e. adherence to content, coverage and dose) assessed using the following strategies:
- All ResN and investigators will undertake a program of training (described in description of intervention(s)/exposure) and ResN will work one-on-one with the CTC for the first few days of data collection, and in turn work with weekend ResN as part of a ‘train the trainer’ strategy. A closed Yammer page available only to investigators and ResN will enable team members to communicate in a secure cyber setting for the duration of the trial.
- Assessment of inter-rater reliability of blinded-to-intervention outcome assessors, including audits to monitor inter-rater reliability during the trial.
- The CTC will monitor study processes undertaken by the ResN (e.g. regular checks of data collection and intervention delivery by the CI and CTC via REDCap).
- Thorough screening/enrollment record kept by ResNs and monitoring by CTC.
- Data relevant to the dose of the intervention (documented in REDCap) will be frequently monitored by the CTC and CI.
Timepoint [5] 369729 0
Daily to monthly for the duration of the trial.
Secondary outcome [6] 370496 0
Process evaluation: patient participation assessed using the Patient Participation in Pressure Injury Prevention Scale.
Timepoint [6] 370496 0
Day 2
Secondary outcome [7] 370497 0
Process evaluation: patient comfort with the dressing assessed using a visual analogue scale ranging from 'Completely uncomfortable' to 'Completely comfortable'
Timepoint [7] 370497 0
Measured daily, up to 14 days
Secondary outcome [8] 370498 0
Process evaluation: patient satisfaction with the dressing assessed using a visual analogue scale ranging from 'Completely satisfied' to 'Completely unsatisfied'
Timepoint [8] 370498 0
measured daily, up to 14 days
Secondary outcome [9] 370499 0
Process evaluation: Participant and staff perspectives, including any issues/difficulties with the intervention, assessed via semi-structured interviews and focus groups, respectively, with data analysed thematically.
Timepoint [9] 370499 0
On the day that the participant exits the clinical trial.

Eligibility
Key inclusion criteria
- At least 18 years of age
- Patient or their proxy able to provide written informed consent
- Assessed as being at-risk of a sacral hospital-acquired pressure injury
- Patient screened for the study within 36 hours of hospital admission
- Expected hospital length of stay of at least 48hrs following recruitment
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Patient admitted to high-dependency, critical care (such as intensive care), maternity, mental health and rehabilitation settings
- Patient is unable to be turned
- Existing sacral PI, injury, skin allergy or lesion in the sacral area at the time of admission
- Patients with urinary and/or faecal incontinence at the time of admission
- Unable to speak or understand English if no interpreter present

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)
Allocation is not concealed.
Note: Registered Nurse Research Assistants (ResN) will determine if a patient is eligible for inclusion. The ResN will use a web-based randomisation program, but once participants are randomised, the ResN will be aware of group allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Following eligibility assessment and consent, participants will be randomized to either the dressing group or routine care only group via a computer-generated 1:1 ratio, in varying block sizes stratified by hospital and division (i.e., medical or surgical). The ResN at each site will log in to a central randomization service website, independent of the trial via a mobile device.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
All randomised patient data will be analysed by intention-to-treat, regardless of treatment received. The patient will be the unit of measurement. The primary outcome, development of a new sacral HAPI is dichotomous. Main analysis will be based on comparisons of the cumulative incidence of pressure injuries in the two groups. Relative risk (RR) of HAPI for the intervention group compared to the control group will be computed and reported along with 95% confidence intervals and P values.
For the secondary endpoints, “time to HAPI” will be analysed using Kaplan-Meier curve and log rank tests. Hazard ratios along with 95% confidence intervals will be reported. As for the “stage of HAPI”, a chi-square test will evaluate if the intervention group differs from the control patients. All data will be entered directly into a web-based data collection tool (REDCap), and then exported into SPSS (V 24). Prior to analysis, a rigorous process of data cleaning to check outlying figures, missing, and implausible data against source data will be undertaken. Sample attrition will be managed via intention-to-treat analysis to ensure an unbiased comparison of the groups by randomization. Cohen’s weighted kappa test will estimate inter-rater reliability. A score of =07 will be considered acceptable. An expert biostatistician will lead all analyses.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 13653 0
Gold Coast University Hospital - Southport
Recruitment hospital [2] 13654 0
Logan Hospital - Meadowbrook
Recruitment hospital [3] 13655 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [4] 13656 0
Royal Brisbane & Womens Hospital - Herston
Recruitment postcode(s) [1] 26339 0
4029 - Herston
Recruitment postcode(s) [2] 26338 0
4102 - Woolloongabba
Recruitment postcode(s) [3] 26337 0
4131 - Meadowbrook
Recruitment postcode(s) [4] 26336 0
4215 - Southport

Funding & Sponsors
Funding source category [1] 302561 0
Government body
Name [1] 302561 0
National Health and Medical Research Council
Address [1] 302561 0
16 Marcus Clarke Street, Canberra ACT 2601
Country [1] 302561 0
Australia
Primary sponsor type
University
Name
Griffith University
Address
Room 2.04, G01, Griffith University, Parklands Drive, Southport QLD 4222
Country
Australia
Secondary sponsor category [1] 302501 0
None
Name [1] 302501 0
Address [1] 302501 0
Country [1] 302501 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 303206 0
Gold Coast Health Human Research Ethics Committee
Ethics committee address [1] 303206 0
Office for Research Governance and Development
Level 2 Block E – Pathology and Education
1 Hospital Boulevard
Southport, QLD, 4215
Ethics committee country [1] 303206 0
Australia
Date submitted for ethics approval [1] 303206 0
13/05/2019
Approval date [1] 303206 0
Ethics approval number [1] 303206 0

Summary
Brief summary
Aims: to determine the clinical and cost-effectiveness of a prophylactic silicone foam border dressing in preventing sacral (tailbone) hospital-acquired pressure injuries (HAPI) in at-risk hospitalised patients; describe the characteristics and clinical care received by patients who develop a sacral HAPI up to 4 weeks, or until hospital discharge or death after sacral HAPI occurrence; and understand patients' and staff perspectives on the use of prophylactic dressing.

Hypotheses: Primary hypothesis: The cumulative incidence of patients who develop sacral HAPI up to 14 days of admission will be less in patients who are randomly allocated to the intervention group (i.e. routine care plus the trial dressing) compared to patients allocated to the control group (i.e. routine care only).
Secondary hypotheses: The intervention group will have better outcomes compared to the control, including 1) time to onset of sacral HAPI; 2) severity of sacral HAPI and; 3) cost-effectiveness.
Trial website
Nil.
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 92846 0
Prof Brigid Gillespie
Address 92846 0
School of Nursing and Midwifery
Room 2.04, G01, Griffith University, Parklands Drive, Southport QLD 4222
Country 92846 0
Australia
Phone 92846 0
+61 7 5687 3245
Fax 92846 0
Email 92846 0
b.gillespie@griffith.edu.au
Contact person for public queries
Name 92847 0
Prof Brigid Gillespie
Address 92847 0
School of Nursing and Midwifery
Room 2.04, G01, Griffith University, Parklands Drive, Southport QLD 4222
Country 92847 0
Australia
Phone 92847 0
+61 7 5687 3245
Fax 92847 0
Email 92847 0
b.gillespie@griffith.edu.au
Contact person for scientific queries
Name 92848 0
Prof Brigid Gillespie
Address 92848 0
School of Nursing and Midwifery
Room 2.04, G01, Griffith University, Parklands Drive, Southport QLD 4222
Country 92848 0
Australia
Phone 92848 0
+61 7 5687 3245
Fax 92848 0
Email 92848 0
b.gillespie@griffith.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Given that there is potential for the data to be re-identifiable; making IPD available may discourage potential participants from agreeing to consent in the study if they know their data will be shared with others.
What supporting documents are/will be available?
Study protocol
Clinical study report
Ethical approval
Summary results
No Results