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Trial registered on ANZCTR


Registration number
ACTRN12613001328763
Ethics application status
Approved
Date submitted
28/11/2013
Date registered
3/12/2013
Date last updated
18/07/2024
Date data sharing statement initially provided
18/07/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Prophylactic dressing to minimise sacral pressure injuries in high risk hospitalised patients: A pilot study
Scientific title
A pilot study comparing prophylactic dressing with routine care versus routine care alone to minimise sacral pressure injuries in hospitalised patients at high risk of developing pressure injury.
Secondary ID [1] 283565 0
Nil known
Universal Trial Number (UTN)
U1111-1150-1556
Trial acronym
Pressure Injury Prevention Pilot Study (PIPPS)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pressure injury prevention 290470 0
Condition category
Condition code
Injuries and Accidents 290861 290861 0 0
Other injuries and accidents
Skin 290862 290862 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Design: The study will use the CONSORT design to test feasibility outcomes over a 12 month period. All participants assessed as ‘high risk’ or greater of PI will be randomly assigned to either a ‘routine care group or dressings group’ . A total of 80 patients will be enrolled (40 per group) which is sufficiently large to yield estimates of effect size for the larger trial. Inclusion criteria: A least 18 years of age; able to provide written informed consent either in person or via guardian; assessed as ‘high risk’ or greater of PI (score of 15+ using the Waterlow Scale at admission); and expected hospital length of stay of at least 72hrs following recruitment. Exclusion criteria: suspected or actual spinal injury; lower back surgery (lumbar spine) which prevents the application of a sacral dressing; existing sacral PI, injury or allergy in the sacral area at the time of hospital admission; faecal incontinence at the time of hospital admission; unable to speak or understand English with no interpreter present. Recruitment: The Research Nurse (ResN) will screen general medical-surgical patients at specified admission entry points for eligibility into the study. If eligible, prospective participants or their guardian will be told about the study at an appropriate time during their admission and provided with sufficient time to read the information and consider their participation. Randomisation: Following consent, the ResN will contact an online randomisation service (based at Griffith University) to obtain a code for random allocation of participants to either the dressings group, or routine care only group. Randomisation will occur using a permuted block approach to ensure even distribution of participants’ diagnostic category (medical and surgical), using a 1:1 ratio with random variations in block sizes. On allocation to the dressings group, the ResN will apply a dressing to the participant’s sacrum, and document their dressing regime in the care plan/chart. Participants allocated to the routine care only group, will continue to receive usual care, as per hospital policy. Protocol fidelity: Education sessions will be conducted for nursing staff in the participating wards during in-service periods in January, 2014 prior to the commencement of trial (i.e., recruitment of participants in February, 2014). The frequency of these sessions will be dependent on the ward in-service schedule, but it is hoped that at least two x 30-60 minute sessions will be conducted in each participating ward area. These sessions will include information about the study, the dressing (including its application) and documentation using the data collection forms located in the end-of-bed charts. Nursing staff will also receive ongoing support by the PI/ResN during the trial period. Blind Assessors will be required to provide evidence of having undertaken pressure injury identification and assessment training using the NDNQI PI classification system and receive training by the PI regarding assessment and documentation using the Blind Assessor Case Report Form. During the study period, inter-rater assessment of 20 photos will be undertaken, by an additional with the expert assessor from being a blinded member of the Stomal Therapy and Wound Management Group. The PI will also provide training to the ResN via an orientation to the research protocol, procedures and data collection tools. Specific areas covered will include recruitment processes, daily data collection and inspection of the prophylactic sacral dressing. Both the ResN and Blind Assessor will also be required to sign a confidentiality agreement to formally recognise and accept their responsibility and obligations regarding the confidentiality of the information provided to them under the provision of the Public Health Act 2005. Regular meetings between the PI ResN and Blind Assessor will be arranged to provide support and ensure study fidelity. Regular random audits by the PI will evaluate the effectiveness of data management practices including the inter-rater reliability of assessment, the timely, accurate and consistent of data collection, and the correct entry of collected data into the electronic database. A trial specific education program will be provided to the ResN, blinded outcome assessors and nursing staff in the participating wards prior to the trial and include information about the study, the dressing and documentation using structured data collection forms. Random audits will be conducted to ensure correct inter-rater reliability of skin assessment and the timeliness, accuracy and consistency of data collection. Intervention: On allocation to the dressings group, the ResN will apply a self-adherent silicone foam bordered dressing to the patient’s sacrum, and document their dressing regime in the patient’s care plan/chart. Participants in the intervention arm will have the sacral dressing replaced every 3 days or sooner if loose or soiled. A number of nurse researchers undertaking quality improvement projects involving sacral foam dressings to prevent PI have reported changing the dressing every 3 days or twice a week safely and with good effect. Therefore this feasibility study will allow where possible, prophylactic silicone foam dressings to remain on intact skin for up to three days before replacement. Dressings will be applied until the participant is discharged from the ward or is mobilising independently. Where a PI is identified on a sacrum, the prophylactic dressing where clinically indicated, will be removed, and care processes actioned as per hospital policy. The dressing will also be removed in instances of skin reaction, faecal incontinence and patient-rated discomfort. Skin reaction will be reported via the incident reporting process and as an Adverse Event. All participants enrolled in both arms of the study will have their sacrum assessed daily by the ResN or RNs. Patients allocated to the routine care group, will continue to receive usual care, as per hospital policy. This consists of regular skin observation and nursing care via use of a pressure redistributing mattress, multi-disciplinary review (such as dietician and stomal therapy and wound management), and second hourly repositioning schedule. Blinding: As all members of the research team, nursing staff and participants will be aware of group allocation, only the outcome assessor(s) will be blinded. At each 72 hour point following admission, a high resolution digital photograph will be taken of each participant’s sacrum. De-identified and coded photographs will be saved to enable blind assessment in an area removed from the participating wards. Dressing: Mepilex (Registered Trademark) Border Sacrum dressings will be used as the prophylactic silicone foam dressing for this feasibility study. Mepilex (Registered Trademark) Border Sacrum dressings are specifically designed for the sacral area, are highly adaptable, comfortable and hypoallergenic. The silicone layer ensures that the dressing can be changed without damaging the wound or surrounding skin or exposing the patient to additional pain thereby minimising the risk for maceration. In addition to this, the dressing can be lifted and adjusted or removed and reapplied to allow for regular observation, without losing its adherent properties. The dressing is also moisture proof so can remain insitu during hygiene cares including showering and poses no risk for patient mobilisation. Advice from the manufacturer suggests the dressing can remain in place for several days when utilised for managing existing pressure injuries. Measures: Baseline characteristics of participants such as age, gender, place of and admission diagnosis, Waterlow score, existing PI (other than sacral), BMI, mobility and smoking status and health history. The primary measure (the presence and severity of sacral PI) will be assessed using PI staging classification systems. Secondary measures will include: 1) reasons for non-completion; 2) comfort, duration, dislodgement and removal of dressings; 3) suitability of recruitment site, time and budget allocation; 4) effectiveness of preparation sessions and level of support provided; 5) suitability of data collection tools; 6) inter-rater reliability, 7) data collection and management practices. Data collection: Recruitment processes will be recorded using the patient screening form. A Case Report Form (CRF) and end-of bed forms will collect data regarding assessment, dressing use, changes and comfort. Blind assessors will have their own CRF for the formal assessment of participant’s sacral area every 72 hours. Random audits will be conducted using a prepared checklist and staff will be evaluated using surveys post-intervention. Data analysis: All randomised participants will be analysed using an intention-to-treat approach as per their allocated group. The incidence and severity of PI will be measured as a categorical variable and proportions of PI in the two groups compared using Chi-squared. Cohen’s weighted kappa test will estimate inter-rate reliability. Logistic regression will be undertaken to estimate the odds ratio. Confidence intervals of 95% will be used for both groups. Secondary measures will be analysed using descriptive statistics. Ethics: This pilot trial will be conducted in accordance with the Helsinki declaration (2008), NHMRC and the National Statement Guidelines (2007) and will be registered with the Australian and New Zealand Trial Registry.
Intervention code [1] 288259 0
Prevention
Comparator / control treatment
Routine care for patients assessed as high risk or greater (that is assessment score of 15+ via a Waterlow assessment ) involves regular skin observation and 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 multi-disciplinary review and second hourly repositioning.
Control group
Active

Outcomes
Primary outcome [1] 290858 0
The specific aim of this pilot study is to test feasibility of this protocol and related processes to inform a larger trial. Hypothesis testing is not possible due to the small sample size.

However, the primary outcome is the presence and severity of PI in patients enrolled in the study. The National Pressure Ulcer Advisory Panel (NPUAP), European Pressure Ulcer Advisory Panel (EPUAP) pressure injury and staging classification system (as reported in the Pan Pacific Clinical Practice Guideline for the Prevention and Management of Pressure Injury), will be used to guide the assessment of the presence and severity of PI. Assessment of patients in both groups will be conducted by a blind nurse assessor via high resolution photographs and occur every third day coinciding with dressing removal in intervention participants, and/or on discharge from the ward.
Timepoint [1] 290858 0
Participants in both groups will be assessed every 3 days until their discharge from ward or until the patient is mobilising independently (that is without 1 or 2 person assist), whichever is sooner.
Secondary outcome [1] 305471 0
Percentage of patients who are approached.
Timepoint [1] 305471 0
January to December, 2014
Secondary outcome [2] 305765 0
Percentage of eligible patients who meet the eligibility criteria.
Timepoint [2] 305765 0
January to December, 2014
Secondary outcome [3] 305766 0
Percentage of eligible patients who do not meet the eligibility criteria and are excluded from the study.
Timepoint [3] 305766 0
January to December, 2014
Secondary outcome [4] 305767 0
Percentage of eligible patients recruited and consented.
Timepoint [4] 305767 0
January to December, 2014
Secondary outcome [5] 305768 0
Percentage of eligible patients who refuse to participate (and why they refused).
Timepoint [5] 305768 0
January to December, 2014
Secondary outcome [6] 305769 0
Percentage of patients who are randomised.
Timepoint [6] 305769 0
January to December, 2014
Secondary outcome [7] 305770 0
Percentage of recruited patients who complete the study.
Timepoint [7] 305770 0
December 2014, or when all recruited participants have completed the intervention or control treatment.
Secondary outcome [8] 305771 0
Percentage of recruited patients who do not complete the study.
Timepoint [8] 305771 0
December 2014, or when all recruited participants have completed the intervention or control treatment.
Secondary outcome [9] 305772 0
Reasons recruited patients were not able to complete the study (including discharge before 72 hours, death, faecal incontinence, skin reaction, discomfort with the dressing, other adverse event).
Timepoint [9] 305772 0
December 2014 or when all recruited participants have completed the intervention or control treatment.
Secondary outcome [10] 305774 0
Baseline characteristics of participants including age, gender, diagnosis or surgery, site of admission, mobility status, body mass index, health comorbidities, current smoking status, Waterlow score, existing PI (other than sacral), and history of PI
Timepoint [10] 305774 0
At baseline, post participant consent and randomisation.
Secondary outcome [11] 305775 0
Average duration (in hours) of applied sacral dressings, as per end-of-bed chart data collection tool.
Timepoint [11] 305775 0
Participant's sacrum will be assessed at least every day or where clinically indicated, until discharge from the ward. Assessment of this timepoint will occur in December 2014, or when all recruited participants have completed the intervention or control treatment.
Secondary outcome [12] 305776 0
Reasons for sacral dressing dislodgement and removal as per end-of-bed chart data collection tool.
Timepoint [12] 305776 0
Participant's sacrum will be assessed at least every day or where clinically indicated, until discharge from the ward. Assessment of this timepoint will occur in December 2014, or when all recruited participants have completed the intervention or control treatment.
Secondary outcome [13] 305777 0
Patient perception of the comfort of the sacral dressing as per a patient comfort survey, purposely designed for this trial (for patients in the intervention group only).
Timepoint [13] 305777 0
Participant's sacrum will be assessed at least every day or where clinically indicated, until discharge from the ward. Assessment of this timepoint will occur in December 2014, or when all recruited participants have completed the intervention or control treatment.
Secondary outcome [14] 305778 0
Suitability of site including admission points (based on recruitment data, specifically the number individuals approached and the number recruited), and chosen wards (based on reasons for participant non-completion data) in the divisions of medicine and surgery.
Timepoint [14] 305778 0
December 2014, or when all recruited participants have completed the intervention or control treatment.
Secondary outcome [15] 305779 0
Suitability of time and budget allocation (based on rate of recruitment, use of dressings and judicious budget management).
Timepoint [15] 305779 0
December 2014, or when all recruited participants have completed the intervention or control treatment.
Secondary outcome [16] 305780 0
Effectiveness of preparatory/ training sessions for nursing staff (in participating admission points and wards in the division of medicine and surgery), research nurses and blind nurse assessors, as per an evaluation survey (Evaluation Survey 1 - For nursing staff), purposely designed for this trial.
Timepoint [16] 305780 0
December 2014, or when all recruited participants have completed the intervention or control treatment.
Secondary outcome [17] 305781 0
Effectiveness of support provided to nursing staff, research nurses and blind nurse assessors, as per an evaluation survey (Evaluation Survey 2 - For blind nurse assessors), purposely designed for this trial.
Timepoint [17] 305781 0
December 2014, or when all recruited participants have completed the intervention or control treatment.
Secondary outcome [18] 305782 0
Suitability of protocol and/or procedure instructions for research nurses, as per an evaluation survey (Evaluation Survey 3 - For research nurses), purposely designed for this trial.
Timepoint [18] 305782 0
December 2014, or when all recruited participants have completed the intervention or control treatment.
Secondary outcome [19] 305783 0
Suitability of data collection tools for nursing staff, research nurses and blind nurse assessors, as per evaluation surveys.
Timepoint [19] 305783 0
December 2014, or when all recruited participants have completed the intervention or control treatment.
Secondary outcome [20] 305784 0
Rate and context of identification of patient group allocation by blind assessor, as per an evaluation survey (Evaluation Survey 2 - For blind nurse assessors), purposely designed for this trial.
Timepoint [20] 305784 0
December 2014, or when all recruited participants have completed the intervention or control treatment.
Secondary outcome [21] 305785 0
Evaluation of inter-rate reliability of PI assessment by nursing staff, research nurses and blind assessor (based on repeat assessment by PI, ResN or member of the Stomal Therapy and Wound Management group).
Timepoint [21] 305785 0
December 2014, or when all recruited participants have completed the intervention or control treatment.
Secondary outcome [22] 305786 0
Evaluation of data management (based on evaluation of end-of bed chart, screening tool, case report form, blind assessor case report form and database) for timeliness, accuracy and consistency of data collection/entry.
Timepoint [22] 305786 0
December 2014, or when all recruited participants have completed the intervention or control treatment.

Eligibility
Key inclusion criteria
* At least 18 years of age (the Princess Alexandra Hospital is an adult-focused tertiary health facility); * Able to provide written informed consent either in person or via their family member or legal guardian; * Assessed as being at ‘high risk’ or greater of PI (as per a risk assessment score of 15+ using the Waterlow Scale at admission entry points into the general medical-surgical context as per PAH policy). * Expected hospital length of stay of at least 72hrs following recruitment (to enable blind assessment at the first formal evaluation).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Suspected or actual spinal injury which prevents the patient being turned; * Lower back surgery (lumbar spine) which prevents the application of a sacral dressing; * Existing sacral PI, injury or allergy in the sacral area at the time of hospital admission; * Faecal incontinence at the time of hospital admission; * Unable to speak or understand English with 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)
The intervention will commence with screening of general medical-surgical patients at specified admission entry points by the Research Nurse (ResN) for eligibility into the study, following routine PI risk assessment using the Waterlow Scale by nursing staff, as per PAH policy. Assessment of PI risk for patients admitted to the general medical-surgical wards at the PAH is via the Waterlow Pressure Injury Continuous Assessment Chart. The Waterlow assessment relies on the rating of 8 categories including build and weight for height, visual assessment of the skin, age, gender, continence, mobility, measure of malnutrition and a number of ‘special risk factors’ (tissue malnutrition, neurological deficits, major surgery and certain medications). Scores vary for each patient based on individual assessment of each category. A score of 15 or above is accepted as the cut-off point for ‘high risk’ of PI and a score of 20 or above as ‘very high risk’. Thus patients assessed as high risk or greater of PI, will be managed using the PAH Risk Assessment Management Flowchart in relation to the patient’s individual condition. This involves use of a pressure redistribution overlay on a standard mattress, or removal of a standard mattress and replacement with a pressure redistributing mattress, possible multi-disciplinary review (such as dietician and stomal therapy and wound management), and second hourly repositioning schedule. All registered and enrolled nurses at the PAH are required to undertake annual pressure injury identification and assessment training using the National Database of Nursing Quality Indicators (NDNQI) PI classification system (based on the NPUAP and EPUAP pressure injury and staging classification systems). Admission entry points will be via the Surgical Care Unit (SCU) and the Emergency Department (ED). Screening at the point of admission will ensure patients are assessed for risk of PI, screened for eligibility and randomised to either the control or intervention group within the first 12 hours of admission to hospital. Prospective participants or their family member or legal guardian will be told about the study at an appropriate time during their admission and provided with sufficient time to read the information and consider their participation. Researchers will not approach patients or their family where informed consent is impossible due to distress or complications associated with their health condition. When consented and randomly allocated to a study group, recruited patients who are assessed as being ‘very high risk’ of PI will have demographic and health status characteristics recorded including age, gender, diagnosis or surgery, site of admission, mobility status, body mass index, health comorbidities, current smoking status, Waterlow score, existing PI (other than sacral), and history of PI. A high resolution photograph of each participant’s sacrum will also be taken at this point as a baseline reference point. Each recruited patient’s name and hospital information (date of birth, UR number and contact phone number) will recorded in a separate document and only be available to the PI/ResN to ensure patient confidentiality (refer to Appendix G – Participant Key). On allocation to the ‘routine care and prophylactic dressings intervention group’ [A], the PI/ResN will apply a self-adherent silicone foam bordered dressing to the patient’s sacrum, and document their dressing regime in the patient’s care plan/chart. Patients allocated to the ‘routine care group’ [B], will continue to receive routine care, as per PAH policy. All patients enrolled the study will have their sacrum assessed at least once a day and preferably each shift (every 8 hours) by the PI/ResN or RNs caring for the patient as per hospital policy recommendations (refer to Case Report Form). For participants in the dressings group, the dressing will be lifted at least once a day to enable regular observation of the sacrum and replaced every 3 days or sooner if it becomes loose or soiled. The dressings will continue to be used in the intervention group patients until their discharge from ward or until the patient is mobilising independently (that is without 1 or 2 person assist), whichever is sooner.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Following eligibility assessment and consent, the ResN will contact the Griffith University Clinical Trials Coordinating Centre to obtain an online code for random allocation of patients. Patients will be randomly assigned to either the ‘prophylactic dressings intervention group’ [A], or ‘routine care group’ [B]. Randomisation will involve a stratified approach to ensure even distribution of participants’ diagnostic category (medical and surgical), as well as a 1:1 ratio with random variations in block sizes. This method will also ensure concealment of allocation prior to randomisation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
As all members of the research team, nursing staff and patient participants will be aware of allocation to either the intervention or control group, only the outcome research assessor(s) will be blinded to group allocation. The presence and severity of sacral PI will be assessed using the NPUAP/ EPUAP pressure injury and staging classification systems (as reported in the Pan Pacific Clinical Practice Guideline for the Prevention and Management of Pressure Injury), which provide clear guidelines for the identification and assessment of PI. At each 72 hour point following admission, enrollment, randomisation and baseline photograph, a high resolution digital photograph will be taken of each participant’s sacrum. De-identified photographs (labelled only with study number, date and time) will be forwarded to a blind assessor via email. This will ensure the blind assessor is able to evaluate each participant’s sacrum at a computer that is completely removed from the participating wards, thereby reducing the risk of bias.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Eligible patient and recruitment numbers, the participant numbers at each measurement wave and attrition data will be reported using a CONSORT style approach. Prior to conducting any statistical analysis, variables will be checked for outliers, distributional properties, missing values and any observable errors in recording, coding or data entry. Sample attrition will be managed via intention-to-treat analysis to ensure an unbiased comparison of the groups produced by randomization. Cohen’s weighted kappa test will estimate inter-rate reliability. A score of 0.7 or less will be considered acceptable.

Statistical comparisons of baseline demographics and clinical characteristics will be undertaken to test for any substantial (statistical) differences between the intervention and routine care group. Descriptive results will be reported using summary statistics, depending on the level and distribution of the data. Continuous/interval data will be expressed as mean +/ - standard deviation or median +/- interquartile range based on normality of data and categorical data will be presented as counts and percentages.

Analysis will specifically address questions related to presence and severity of PI as well as questions related to secondary endpoints related to study administration, resource and data management and fidelity of the pilot:
1. What is the difference in the occurrence of sacral PI between study groups?
2. What is the difference in the severity of sacral PI between study groups?
3. What is the percentage of patients who were approached?
4. What percentage of patients met the eligibility criteria?
5. What percentage of patients did not meet the eligibility criteria?
6. What percentage of eligible patients were recruited and consented?
7. What percentage of eligible patients who refused to be recruited?
8. What percentage of recruited patients who were randomised?
9. What percentage of recruited patients completed the study?
10. What percentage of recruited patients did not complete the study?
11. What are the reasons recruited patients were not able to complete the study?
12. What are the baseline characteristics of the study population?
13. What is the average duration (in hours) of applied sacral dressings?
14. What are the reasons for sacral dressing dislodgement and removal?
15. How do patients perceive the comfort of the sacral dressing?
16. What is the suitability of site including admission points and chosen wards in the divisions of medicine and surgery?
17. What is the suitability of time and budget allocation?
18. How effective are preparatory/training sessions for nursing staff (in participating admission points and wards in the division of medicine and surgery), research nurses and blind nurse assessors?
19. How effective is support provided to nursing staff, research nurses and blind nurse assessors?
20. What is the suitability of protocol and/or procedure instructions for research nurses?
21. What is the suitability of data collection tools for nursing staff, research nurses and blind nurse assessors?
22. What is the rate and context of identification of patient group allocation by blind assessor?
23. What is the reliability of inter-rater PI assessment by nursing staff, research nurses and blind assessor?
24. What is the timeliness, accuracy and consistency of data management (based on evaluation of end-of bed chart, screening tool, case report form, blind assessor case report form and database)?

Statistical analyses will be performed using SPSS, version 21. Confidence intervals of 95% will be used for all descriptive tests.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
10/02/2014
Actual
18/02/2014
Date of last participant enrolment
Anticipated
29/08/2014
Actual
18/07/2014
Date of last data collection
Anticipated
31/12/2024
Actual
Sample size
Target
1320
Accrual to date
Final
896
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 1677 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 7553 0
4102 - Buranda

Funding & Sponsors
Funding source category [1] 288248 0
University
Name [1] 288248 0
NHMRC Centre of Research Excellence in Nursing (NCREN)
Country [1] 288248 0
Australia
Funding source category [2] 288355 0
University
Name [2] 288355 0
Centre for Health Practice Innovation
Country [2] 288355 0
Australia
Primary sponsor type
University
Name
Griffith University
Address
170 Kessels Road
Nathan QLD 4111
Country
Australia
Secondary sponsor category [1] 286963 0
Hospital
Name [1] 286963 0
Princess Alexandra Hospital
Address [1] 286963 0
Ipswich Road Woolloongabba QLD 4102
Country [1] 286963 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290148 0
Metro South Human Research Ethics Committee
Ethics committee address [1] 290148 0
Level 7
Centre for Health Research
Translational Research Institute
Woolloongabba QLD 4102
Ethics committee country [1] 290148 0
Australia
Date submitted for ethics approval [1] 290148 0
Approval date [1] 290148 0
10/10/2013
Ethics approval number [1] 290148 0
HREC/13/QPAH/448
Ethics committee name [2] 290149 0
Griffith University Human Research Ethics Committee
Ethics committee address [2] 290149 0
Office for Research
Bray Centre,
170 Kessels Road
Nathan QLD 4111
Ethics committee country [2] 290149 0
Australia
Date submitted for ethics approval [2] 290149 0
Approval date [2] 290149 0
21/10/2013
Ethics approval number [2] 290149 0
NRS/51/13/HREC

Summary
Brief summary
Pressure injury (PI) causes pain, discomfort and immobility for patients, leading to increased length of hospital stay and cost. Although preventable, hospital acquired PI in Queensland in 2011 was 8.8% for patients overall. The sacrum is identified as one of the most common PI sites for patients. Special dressings may reduce PI, however rigorous testing has not been undertaken thus their benefit remains unclear. Further investigation using a pilot randomised controlled trial will assess the feasibility of undertaking a full-scale trial to test the efficacy of this dressing in reducing sacral PI with the potential of improving patient health and economic outcomes.
Trial website
Trial related presentations / publications
Walker R, Aitken LM, Huxley L, Juttner M. Prophylactic dressing to minimize sacral pressure injuries in high-risk hospitalized patients: a pilot study. Journal of Advanced Nursing. 2015;71(3):688-96.
Public notes

Contacts
Principal investigator
Name 44198 0
Dr Rachel Walker
Address 44198 0
Nursing Practice Development Unit (Building 15, level 2)
Princess Alexandra Hospital
Ipswich Road
Woolloongabba QLD 4102
Country 44198 0
Australia
Phone 44198 0
+61 (0)7 3176 5843
Fax 44198 0
+61 (0)7 3176 7356
Email 44198 0
[email protected]
Contact person for public queries
Name 44199 0
Rachel Walker
Address 44199 0
Nursing Practice Development Unit (Building 15, level 2)
Princess Alexandra Hospital
Ipswich Road
Woolloongabba QLD 4102
Country 44199 0
Australia
Phone 44199 0
+61 (0)7 3176 5843
Fax 44199 0
+61 (0)7 3176 7356
Email 44199 0
[email protected]
Contact person for scientific queries
Name 44200 0
Rachel Walker
Address 44200 0
Nursing Practice Development Unit (Building 15, level 2)
Princess Alexandra Hospital
Ipswich Road
Woolloongabba QLD 4102
Country 44200 0
Australia
Phone 44200 0
+61 (0)7 3176 5843
Fax 44200 0
+61 (0)7 3176 7356
Email 44200 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


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
23297Study protocolWalker RM, Chaboyer W, Cooke M, Whitty JA, Thalib L, Lookwood I, Latimer S, Campbell J, Probert R, Gillespie B. EffEctiveness of Prophylactic fOam dressings in the prevention of saCral pressure injuries in at-risk hospitalised patients (the EEPOC Trial): A multicentre, pragmatic randomised controlled trial protocol and update. BMC Trials. 2023; 24:70 https://doi.org/10.1186/s13063-022-06999-yhttps://doi.org/10.1186/s13063-022-06999-y[email protected]
23298Other    Approval from NHMRC to extend the duration of the ... [More Details] 365285-(Uploaded-21-05-2024-13-16-28)-Study-related document.pdf



Results publications and other study-related documents

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