Pressure Ulcer Prevention in Intensive Care Unit (ICU)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01356459
Recruitment Status : Completed
First Posted : May 19, 2011
Last Update Posted : May 12, 2015
Information provided by (Responsible Party):
Melbourne Health

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.

Condition or disease Intervention/treatment
Pressure Ulcers Device: Mepilex Border Dressing

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 440 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official 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
Study Start Date : June 2011
Primary Completion Date : January 2013
Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pressure Sores
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Intervention
Patients in this arm will have Mepilex dressings applied to their sacrum and heels
Device: Mepilex Border Dressing
Soft silicone self adherent dressing
Other Names:
  • Mepilex Border Sacrum
  • Mepilex Heel
No Intervention: Control
Patients in this arm will have standard care

Primary Outcome Measures :
  1. Pressure ulcer incidence [ Time Frame: Weekly ]
    Number of pressure ulcers developed in the ICU per week

Secondary Outcome Measures :
  1. Cost [ Time Frame: Weekly ]
    The cost of treating developed pressure versus the cost of preventing the development of pressure ulcers

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • ED and ICU admission for critical illness and/or major trauma Over 18 years old

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01356459

Australia, Victoria
Royal Melbourne Hospital
Melbourne, Victoria, Australia, 3050
Sponsors and Collaborators
Melbourne Health

Responsible Party: Melbourne Health Identifier: NCT01356459     History of Changes
Other Study ID Numbers: 2010.261
First Posted: May 19, 2011    Key Record Dates
Last Update Posted: May 12, 2015
Last Verified: May 2015

Keywords provided by Melbourne Health:
Pressure ulcers

Additional relevant MeSH terms:
Pressure Ulcer
Pathologic Processes
Skin Ulcer
Skin Diseases