CompletedPhase 3Phase 4ACTRN12615001212549

Randomised Controlled Trial comparing prophylactic dressings versus standard care in acute care to manage the microclimate and prevent pressure injury and reduce costs (microPUP)

A study among ICU patients comparing prophylactic dressings versus standard care to prevent the incidence and costs associated with pressure injuries.


Sponsor

La Trobe University

Enrollment

336 participants

Start Date

Feb 29, 2016

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria3

  • Patients will be eligible if they:
  • Are 18+ years of age
  • Have been admitted to the Intensive Care Unit.

Exclusion Criteria6

  • Patients will be excluded from the study if they have:
  • Burn or Toxic epidermal necrolysis (TEN) injuries
  • 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
  • An open chest wound requiring strict spinal immobilisation
  • Been clinically assessed as having non-survivable injuries, requiring palliation or organ donation.
  • A known allergy or sensitivity to silicone.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

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

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.


Locations(1)

The Alfred - Prahran

VIC, Australia

View Full Details on ANZCTR

For the most up-to-date information, visit the official listing.

Visit

ACTRN12615001212549