ANZCTR - Registration

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]

Nil

Universal Trial Number (UTN)

Trial acronym

microPUP

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Pressure injuries

Condition category

Condition code

Skin

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]

Treatment: Devices

Intervention code [2]

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]

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]

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]

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]

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]

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]

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]

Epidermal hydration assessed using the SD202 Skin Measurement Device( CK Electronics).

Timepoint [1]

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]

Skin temperature measured with an infrared thermographic scanner (DermaTemp Registered Trademark).

Timepoint [2]

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]

ICU / acute care episode costs determined from a review of hospital records

Timepoint [3]

For the duration of ICU and acute care episode stay assessed after discharge.

Secondary outcome [4]

Erythema assessed using the SD202 Skin Measurement Device( CK Electronics).

Timepoint [4]

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

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]

The Alfred - Prahran

Recruitment postcode(s) [1]

3181 - Prahran

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Smith & Nephew Pty Ltd

Country [1]

United Kingdom

Primary sponsor type

University

Name

La Trobe University

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Country [1]

Other collaborator category [1]

Hospital

Name [1]

Alfred Health

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Alfred Health Human Research Ethics Committee

Ethics committee address [1]

55 Commercial Road, Prahran, VIC 3181

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

13/08/2015

Approval date [1]

09/09/2015

Ethics approval number [1]

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

Public notes

n/a

Contacts

Principal investigator

Name

A/Prof William McGuiness

Address

La Trobe Alfred Clinical School
Level 4, The Alfred Centre
99 Commercial Road, Prahran, Victoria, 3181

Country

Australia

Phone

+613 9479 6743

Email

w.mcguiness@latrobe.edu.au

Contact person for public queries

Name

Charne Miller

Address

La Trobe Alfred Clinical School
Level 4, The Alfred Centre
99 Commercial Road, Prahran, Victoria, 3181

Country

Australia

Phone

+613 94796774

Email

c.miller@latrobe.edu.au

Contact person for scientific queries

Name

Charne Miller

Address

La Trobe Alfred Clinical School
Level 4, The Alfred Centre
99 Commercial Road, Prahran, Victoria, 3181

Country

Australia

Phone

+613 94796774

Email

c.miller@latrobe.edu.au

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