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Trial details imported from

For full trial details, please see the original record at

Registration number
Ethics application status
Date submitted
Date registered
Date last updated

Titles & IDs
Public title
Pressure Ulcer Prevention in Intensive Care Unit (ICU)
Scientific title
A Prospective Randomised Controlled Trial of the Effectiveness of Absorbent Silicone Self Adherent Dressings in the Prevention of Sacral and Heel Pressure Ulcers in Trauma and Critically Ill ED/ICU Patients
Secondary ID [1] 0 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pressure Ulcers 0 0
Condition category
Condition code
Skin 0 0 0 0
Other skin conditions
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Study type
Description of intervention(s) / exposure
Treatment: Devices - Mepilex Border Dressing

Experimental: Intervention - Patients in this arm will have Mepilex dressings applied to their sacrum and heels

No Intervention: Control - Patients in this arm will have standard care

Treatment: Devices: Mepilex Border Dressing
Soft silicone self adherent dressing

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Primary outcome [1] 0 0
Pressure ulcer incidence - Number of pressure ulcers developed in the ICU per week
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Cost - The cost of treating developed pressure versus the cost of preventing the development of pressure ulcers
Timepoint [1] 0 0

Key inclusion criteria
- ED and ICU admission for critical illness and/or major trauma Over 18 years old
Minimum age
18 Years
Maximum age
No limit
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
- Less than 18 years old Suspected or actual spinal injury Pre-existing sacral or heel
pressure ulcer Trauma to sacral and/or heel area

Study design
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?

Intervention assignment
Other design features
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Royal Melbourne Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3050 - Melbourne

Funding & Sponsors
Primary sponsor type
Melbourne Health

Ethics approval
Ethics application status

Brief summary
The study is designed as a randomised controlled trial of trauma patients admitted to the
Royal Melbourne Hospital (RMH) Emergency Department (ED) and subsequently transferred to the
Intensive Care Unit (ICU). Patients meeting the study inclusion criteria will be randomly
allocated to either the control group that will receive usual pressure ulcer prevention
strategies or the trial group that will receive usual care plus have a Mepilex Border Sacrum
dressing applied to their sacrum and Mepilex Boarder Heel dressing applied to each heel in
the ED.

Hypothesis:Patients treated with Mepilex Border dressings will have a lower incidence rate of
sacral and heel pressure ulcer development than patients receiving standard care.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications