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Trial registered on ANZCTR


Registration number
ACTRN12615001212549
Ethics application status
Approved
Date submitted
21/10/2015
Date registered
6/11/2015
Date last updated
5/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Randomised Controlled Trial comparing prophylactic dressings versus standard care in acute care to manage the microclimate and prevent pressure injury and reduce costs (microPUP)
Scientific title
A study among ICU patients comparing prophylactic dressings versus standard care to prevent the incidence and costs associated with pressure injuries.
Secondary ID [1] 287718 0
Nil
Universal Trial Number (UTN)
Trial acronym
microPUP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pressure injuries 296552 0
Condition category
Condition code
Skin 296817 296817 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention: ALLEVYN Life dressing is a multi-layered design incorporating hydrocellular foam, hyper-absorber lock away core and masking layer. Indications for use: ALLEVYN
Alleyvn Life dressings will be placed on participant sacrum, both heels, and the occiput (if the occiput has been shaved for the purpose of clinical care) at the next scheduled repositioning after recruitment and randomisation.
To apply ALLEVYN Life follow the steps below:
1. Cleanse the skin in accordance with local clinical protocol.
2. Select an appropriate dressing size.
3. Prepare and clean the skin.
4. Using a clean technique remove one of the protector films from ALLEVYN Life and anchor the adhesive side of the dressing to the skin. Smooth the dressing over the skin ensuring there are no creases. When positioning ALLEVYN Life Sacrum dressings, place the narrow end of the dressing a minimum of 2cm (3/4in.) above the anal sphincter, then smooth the dressing over the sacrum.
5. Remove the remaining protector film and smooth the dressing over the remainder of the wound without stretching, ensuring no creases.

Heel and occiput dressings can be left in place undisturbed for up to 7 days. Sacrum dressings can be left in place for up to 5 days. All dressings will be changed more frequently if soiled.
To remove ALLEVYN Life, lift the edge of the dressing and slowly peel back until completely removed from the skin. ALLEVYN Life Sacrum should be removed from the top edge down towards the anus to minimise the potential for faecal contamination.

The dressings are indicated for single use only. Use of the dressings will continue for the participants stay in ICU and can be removed upon discharge from ICU, for example to a general ward.

The dressings will be placed by Alfred Health staff working in the ICU. This includes ICU nurses and research officers employed for this trial as they will have honorary Alfred Health status. The dressing is applied in addition to standard care. Dressing changes will be monitored using a data collection log maintained by the research officers employed for the trial and informed by changes sighted by the research officers as well as the dressing changes recorded on the ICU progress notes.
Intervention code [1] 293106 0
Treatment: Devices
Intervention code [2] 293176 0
Prevention
Comparator / control treatment
No prophylactic dressing - usual pressure injury prevention strategies.
At the study setting standard practice includes a number of strategies to address the development of pressure injuries as informed by the Pan Pacific Clinical Practice for the Prevention and Management of Pressure Injury. The Institution has a Pressure injury Prevention Policy, a Pressure Injury Prevention and Management Guideline, and a Nutrition Intervention to Promote Pressure Injury Healing Guideline. The ICU has additional written technical instruction called ICU Pressure Injury Prevention Strategies. Standard care will be implemented in accordance with these guidelines. Standard care in these guidelines require skin and pressure injury risk assessment within 8 hours of admission, a documented pressure injury prevention plan within 24 hours of admission. Additional instruction is provided to guide the conduct of the skin and pressure injury risk assessment. Mandatory pressure injury prevention strategies implemented for all patients include initial and ongoing daily skin and pressure risk assessment, assessment and management of all bony prominences at risk of pressure damage, use of slide sheets when moving the patient, nutritional risk assessment. Patients are repositioned four hourly unless more frequent repositioning is indicated, low air loss mattress is used if spinal clearance received, heel wedges are used for off-loading, and skin care include the use of barrier creams and solutions and management of incontinence.

Control group
Active

Outcomes
Primary outcome [1] 296413 0
Pressure injury incidence on the sacrum during ICU stay. Pressure injuries will be classified as per the NPUAP / EPUAP pressure injury classification system. Pressure injuries are classified according to four stages; Stage 1 PI involves non-blanchable erythema, Stage 2 PI involves partial thickness skin loss, Stage 3 PI involves full thickness skin loss, and at the most severe a Stage 4 PI involves full thickness skin loss which the bone, tendon or muscle is exposed. Research Officers will be responsible for assessing skin and determining the presence and stage of a pressure injury. Research Officers will be trained in assessing pressure injuries, inter-rater reliability will be determined. .
Timepoint [1] 296413 0
Assessed at repositioning changes that are scheduled four hourly rotating through the ICU pods between 8-11am and 12-3pm every day, or at unscheduled repositioning's that are required for a patient's clinical care during day shift hours. Time point is any occurrence during ICU stay.
Primary outcome [2] 296504 0
Pressure injury incidence on the heels during ICU stay. Pressure injuries will be classified as per the NPUAP / EPUAP pressure injury classification system. Pressure injuries are classified according to four stages; Stage 1 PI involves non-blanchable erythema, Stage 2 PI involves partial thickness skin loss, Stage 3 PI involves full thickness skin loss, and at the most severe a Stage 4 PI involves full thickness skin loss which the bone, tendon or muscle is exposed. Research Officers will be responsible for assessing skin and determining the presence and stage of a pressure injury. Research Officers will be trained in assessing pressure injuries, inter-rater reliability will be determined. .
Timepoint [2] 296504 0
Assessed at repositioning changes that are scheduled four hourly rotating through the ICU pods between 8-11am and 12-3pm every day, or at unscheduled repositioning's that are required for a patient's clinical care during day shift hours. Time point is any occurrence during ICU stay.
Primary outcome [3] 296533 0
Pressure injury incidence on the occiput if the occiput has been shaved as part of routine clinical care during ICU stay. Pressure injuries will be classified as per the NPUAP / EPUAP pressure injury classification system. Pressure injuries are classified according to four stages; Stage 1 PI involves non-blanchable erythema, Stage 2 PI involves partial thickness skin loss, Stage 3 PI involves full thickness skin loss, and at the most severe a Stage 4 PI involves full thickness skin loss which the bone, tendon or muscle is exposed. Research Officers will be responsible for assessing skin and determining the presence and stage of a pressure injury. Research Officers will be trained in assessing pressure injuries, inter-rater reliability will be determined.
Timepoint [3] 296533 0
Assessed at repositioning changes that are scheduled four hourly rotating through the ICU pods between 8-11am and 12-3pm every day, or at unscheduled repositioning's that are required for a patient's clinical care during day shift hours. Time point is any occurrence during ICU stay.
Secondary outcome [1] 318385 0
Epidermal hydration assessed using the SD202 Skin Measurement Device( CK Electronics).
Timepoint [1] 318385 0
Assessed at repositioning changes that are scheduled four hourly rotating through the ICU pods between 8-11am and 12-3pm every day, or at unscheduled repositioning's that are required for a patient's clinical care during day shift hours.
.
Secondary outcome [2] 318386 0
Skin temperature measured with an infrared thermographic scanner (DermaTemp Registered Trademark).
Timepoint [2] 318386 0
Assessed at repositioning changes that are scheduled four hourly rotating through the ICU pods between 8-11am and 12-3pm every day, or at unscheduled repositioning's that are required for a patient's clinical care during day shift hours.
Secondary outcome [3] 318387 0
ICU / acute care episode costs determined from a review of hospital records
Timepoint [3] 318387 0
For the duration of ICU and acute care episode stay assessed after discharge.
Secondary outcome [4] 318630 0
Erythema assessed using the SD202 Skin Measurement Device( CK Electronics).
Timepoint [4] 318630 0
Assessed at repositioning changes that are scheduled four hourly rotating through the ICU pods between 8-11am and 12-3pm every day, or at unscheduled repositioning's that are required for a patient's clinical care during day shift hours.

Eligibility
Key inclusion criteria
Patients will be eligible if they:

1. Are 18+ years of age
2. Have been admitted to the Intensive Care Unit.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients will be excluded from the study if they have:
1. Burn or Toxic epidermal necrolysis (TEN) injuries
2. Existing injuries which have resulted in a break in the skin on either the sacrum or heels at the location of the skin assessment or the areas are otherwise determined not to be viable for assessment on admission
3. An open chest wound requiring strict spinal immobilisation
4. Been clinically assessed as having non-survivable injuries, requiring palliation or organ donation.
5. A known allergy or sensitivity to silicone.

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 randomised order will be individually printed and placed into opaque sealed envelopes. Envelopes will be numbered and opened consecutively. Allocation will be coordinated by the Research Assistant once a patient has been deemed eligible and consent has been obtained..
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation lists will be generated using a random number function in Microsoft excel.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
n/a
Phase
Phase 3 / Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
Parametric and non-parametric measures will be used to compare the intervention and control groups at baseline to assess the effectiveness of randomisation to achieve comparable groups.
Analysis of the primary outcome measure will be conducted using a Cox’s Proportional Hazard model. An intention to treat analysis will be performed.
Repeated measures analysis of variance will assess differences in epidermal hydration, erythema and temperature for the two study groups, as well as the group of participants who developed a pressure injury and those that did not.
Path analyses of a mediation model will be conducted using AMOS structure equation modelling to further assess the role of microclimate in mediating pressure injury development for the two study groups.

To show a significant reduction of pressure injuries from 15.6% in the control to 3.1% in the intervention (an odds ratio of 5.78), a population prevalence of 10%, a power estimate of 0.80, and a significance level of 0.05, a total sample size of n=305 would be required. Allowing for a 10% attrition, a sample size of n=168 per arm (total n=336) will be sought.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
25/11/2015
Actual
29/02/2016
Date of last participant enrolment
Anticipated
29/06/2016
Actual
17/10/2016
Date of last data collection
Anticipated
Actual
17/10/2016
Sample size
Target
336
Accrual to date
Final
218
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 4497 0
The Alfred - Prahran
Recruitment postcode(s) [1] 10691 0
3181 - Prahran

Funding & Sponsors
Funding source category [1] 292263 0
Commercial sector/Industry
Name [1] 292263 0
Smith & Nephew Pty Ltd
Country [1] 292263 0
United Kingdom
Primary sponsor type
University
Name
La Trobe University
Address
Bundoora, Corner Plenty Road & Kingsbury Drive, Victoria, Australia. 3083
Country
Australia
Secondary sponsor category [1] 290936 0
None
Name [1] 290936 0
Address [1] 290936 0
Country [1] 290936 0
Other collaborator category [1] 278674 0
Hospital
Name [1] 278674 0
Alfred Health
Address [1] 278674 0
55 Commercial Road, Melbourne, Victoria 3004
Country [1] 278674 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293733 0
Alfred Health Human Research Ethics Committee
Ethics committee address [1] 293733 0
55 Commercial Road, Prahran, VIC 3181
Ethics committee country [1] 293733 0
Australia
Date submitted for ethics approval [1] 293733 0
13/08/2015
Approval date [1] 293733 0
09/09/2015
Ethics approval number [1] 293733 0
374/15

Summary
Brief summary
Pressure injury prevalence in intensive care units remains high, 13.1% to 28.7%, despite efforts to stem the prevalence through the implementation of best practice guidelines. Pressure injuries are avoidable, but medical attention goes first and foremost to the task of stabilising the patient’s condition. Pressure injuries occur when patients are immobilised on admission to hospital as a precautionary measure until spinal injury is excluded, during lengthy hours of surgery and during recovery.
Recently, interest in a remarkably simple approach that can reduce the incidence of pressure injury has emerged. The strategy—prophylactic application of a dressing product to areas at risk of pressure injury—has been seen to almost eliminate the incidence of pressure injury on the sacrum and heel and resulted in acute care expenses that were 3.6 times cheaper than usual care. It is suggested that the reason the dressings are effective is because they manage the microclimate of the skin and, specifically, they reduce the amount of moisture on the skin.

Though a systemic review of existing trials support the efficacy of this clinical approach, this theory of microclimate management has not, however, been tested in clinical trials to date. More research is needed to confirm prior study results and test if the intervention does alter the microclimate.
Participants in this study (n=336) will have been admitted to an Intensive Care Unit (ICU). All patients meeting the eligibility criteria will be randomised to either the prophylactic dressing and standard care study condition (intervention) or the standard care study condition (control).
Dressings will be applied to the sacrum, both heels, and the occiput if shaved. The dressing will remain in place for the participant’s duration in the ICU. The primary outcome measure will be the occurrence of a pressure injury in these anatomical locations during their stay in the ICU. Epidermal hydration, erythema and temperature of the pressure prone areas will be assessed for every study participant at scheduled repositioning of the participant during day shift hours.
Monitoring of PI’s elsewhere on the body and during the entire acute episode will be undertaken. The cost of the ICU stay and the full acute episode will be monitored. The incidence of PI development and changes in microclimate state at each anatomical location and cost of care will be compared between the intervention and control groups.
Trial website
n/a
Trial related presentations / publications
n/a
Public notes
n/a

Contacts
Principal investigator
Name 61106 0
A/Prof William McGuiness
Address 61106 0
La Trobe Alfred Clinical School
Level 4, The Alfred Centre
99 Commercial Road, Prahran, Victoria, 3181
Country 61106 0
Australia
Phone 61106 0
+613 9479 6743
Fax 61106 0
Email 61106 0
[email protected]
Contact person for public queries
Name 61107 0
Charne Miller
Address 61107 0
La Trobe Alfred Clinical School
Level 4, The Alfred Centre
99 Commercial Road, Prahran, Victoria, 3181
Country 61107 0
Australia
Phone 61107 0
+613 94796774
Fax 61107 0
Email 61107 0
[email protected]
Contact person for scientific queries
Name 61108 0
Charne Miller
Address 61108 0
La Trobe Alfred Clinical School
Level 4, The Alfred Centre
99 Commercial Road, Prahran, Victoria, 3181
Country 61108 0
Australia
Phone 61108 0
+613 94796774
Fax 61108 0
Email 61108 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



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