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Pressure Ulcer Prevention in Intensive Care Unit (ICU)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01356459
First Posted: May 19, 2011
Last Update Posted: May 12, 2015
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.
Information provided by (Responsible Party):
Melbourne Health
  Purpose

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 Intervention
Pressure Ulcers Device: Mepilex Border Dressing

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Melbourne Health:

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


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


Enrollment: 440
Study Start Date: June 2011
Study Completion Date: June 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01356459


Locations
Australia, Victoria
Royal Melbourne Hospital
Melbourne, Victoria, Australia, 3050
Sponsors and Collaborators
Melbourne Health
  More Information

Responsible Party: Melbourne Health
ClinicalTrials.gov Identifier: NCT01356459     History of Changes
Other Study ID Numbers: 2010.261
First Submitted: May 17, 2011
First Posted: May 19, 2011
Last Update Posted: May 12, 2015
Last Verified: May 2015

Keywords provided by Melbourne Health:
Pressure ulcers
ICU
Prevention

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