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Prevention of Sacral Pressure Ulcers With Preventive Dressings (SACRESS)

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.
ClinicalTrials.gov Identifier: NCT01640418
Recruitment Status : Completed
First Posted : July 13, 2012
Last Update Posted : July 21, 2015
Sponsor:
Information provided by (Responsible Party):
Maastricht University Medical Center

Brief Summary:
In this study we would like to find a way to prevent sacral pressure ulcers in high-risk patients by the use of a Mepilex sacral dressing. The research question we would like to answer is the following: Is the Mepilex sacral dressing a cost-effective dressing for the prevention of grade I to grade IV pressure ulcers in the sacral region in higher-risk hospitalized patients?

Condition or disease Intervention/treatment
Grade I to Grade IV Pressure Ulcers in Higher Risk Patients Device: Mepilex® Border Sacrum dressings

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 253 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Study Start Date : September 2012
Primary Completion Date : October 2013
Study Completion Date : October 2013

Resource links provided by the National Library of Medicine

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

Arm Intervention/treatment
Experimental: Mepilex® Border Sacrum dressings
Mepilex® Border Sacrum dressings
Device: Mepilex® Border Sacrum dressings
Mepilex® Border Sacrum dressings
No Intervention: Standard Care
Standard Care



Primary Outcome Measures :
  1. To compare the number of patients who develop sacral pressure ulcers between the group with the Mepilex® Border Sacrum dressings (Group A) and the group without any sacral dressings (Group B). [ Time Frame: 8 weeks ]
    till hospital release, max 8 weeks



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:

  • Age: ≥18 years
  • Admission in one of the ten high-risk departments of the azM
  • Suspected hospital stay of 5 days or more after admission
  • Braden score 19 or less

Exclusion Criteria:

  • Age: <18 years
  • Pre-existing sacral pressure ulcer
  • Pre-existing trauma to the sacrum
  • Patient is unable to speak Dutch
  • Patients with an inability to give informed consent
  • Patients who are unable to give informed consent within 24h after admission
  • Patients who are unable to give informed consent before surgery

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): NCT01640418


Locations
Netherlands
Academic Hospital of Maastricht
Maastricht, Netherlands, 6229 HX
Sponsors and Collaborators
Maastricht University Medical Center
Investigators
Principal Investigator: Nicole Bouvy Academic Hospital of Maastricht

Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT01640418     History of Changes
Other Study ID Numbers: NL40299.068.12
First Posted: July 13, 2012    Key Record Dates
Last Update Posted: July 21, 2015
Last Verified: July 2015

Keywords provided by Maastricht University Medical Center:
pressure ulcer
dressing
prevention
higher risk patients

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