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Pressure Ulcer Prevention in Intensive Care Unit (ICU)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by Melbourne Health.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Melbourne Health
ClinicalTrials.gov Identifier:
NCT01356459
First received: May 17, 2011
Last updated: May 18, 2011
Last verified: May 2011
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

U.S. FDA Resources

Further study details as provided by Melbourne Health:

Primary Outcome Measures:
  • Pressure ulcer incidence [ Time Frame: Weekly ] [ Designated as safety issue: No ]
    Number of pressure ulcers developed in the ICU per week


Secondary Outcome Measures:
  • Cost [ Time Frame: Weekly ] [ Designated as safety issue: No ]
    The cost of treating developed pressure versus the cost of preventing the development of pressure ulcers


Estimated Enrollment: 440
Study Start Date: April 2011
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: December 2012 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01356459

Locations
Australia, Victoria
Royal Melbourne Hospital Recruiting
Melbourne, Victoria, Australia, 3050
Contact: Nick Santamaria, PhD     61 3 93424168     nick.santamaria@mh.org.au    
Principal Investigator: Nick Santamaria, RN PhD            
Sponsors and Collaborators
Melbourne Health
  More Information

No publications provided

Responsible Party: Professor Nick Santamaria, Professor of Nursing Research, Melbourne Health & University of Melbourne
ClinicalTrials.gov Identifier: NCT01356459     History of Changes
Other Study ID Numbers: 2010.261
Study First Received: May 17, 2011
Last Updated: May 18, 2011
Health Authority: Australia: Human Research Ethics Committee

Keywords provided by Melbourne Health:
Pressure ulcers
ICU
Prevention

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

ClinicalTrials.gov processed this record on May 19, 2013