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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01356459




Registration number
NCT01356459
Ethics application status
Date submitted
17/05/2011
Date registered
19/05/2011
Date last updated
12/05/2015

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
2010.261
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

Intervention/exposure
Study type
Interventional
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

Outcomes
Primary outcome [1] 0 0
Pressure ulcer incidence
Timepoint [1] 0 0
Weekly
Secondary outcome [1] 0 0
Cost
Timepoint [1] 0 0
Weekly

Eligibility
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
Sex
Both males and females
Can healthy volunteers participate?
No
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
Prevention
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
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2013
Sample size
Target
Accrual to date
Final
440
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Royal Melbourne Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3050 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Melbourne Health
Address
Country

Ethics approval
Ethics application status

Summary
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
https://clinicaltrials.gov/ct2/show/NCT01356459
Trial related presentations / publications
Public notes

Contacts
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

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01356459